Abstracts

O1 Challenges in Establishing a Biorepository in a Veterinary Research Facility

P. Johnston

Vaccine Diagnostics and Development, Agricultural Research Council, Pretoria, Gauteng, South Africa

Background: Worldwide concerns over emerging transboundary infectious zoonotic diseases have increased demands on veterinary diagnostic laboratories. However, biobanking is unlikely to be a top priority, especially in disadvantaged or recently developed nations, because the industry frequently operates with little capacity.

Objectives: In recent years, the Agricultural Research Council-Onderstepoort Veterinary Research (ARC-OVR) has undertaken to establish a biorepository to provide a secure facility for processing, storage, and maintenance of quality biological samples within the campus.

Method: To develop this facility, the ARC-OVR facility focused on the following key areas: 1) National/Regional Regulations and Standards; 2) Biosafety Awareness; 3) Infrastructure; 4) Administrative Controls and Management Procedures; 6) Bio Curriculum; 7) Education; and 8) Biobanking Associations, Professional Competency, and Credentialing.

Results: Several challenges were experienced; the infrastructure does not meet the requirements due to several security issues. Resources are limited, particularly in terms of reliable power and internet connectivity. Power interruptions shorten the lifespan of freezer compressors and other instruments, and the cost of fuel to run the backup generators fluctuates, adding to the operating costs. Obtaining the required equipment and supplies for laboratories can be expensive and time-consuming. Funding of infrastructure places a focus on grants and contracts made to support the beginning of a program with an integrated sustainability plan. Academic and institutional-industrial relationships are frequently regarded as reliable sources of funding, yet they are constrained by shifting economic objectives. Lastly, maintaining a strict ethical division between biological materials gathered for “commercial” programs and those obtained for “open collections” is a source of concern.

Conclusion: Biorepositories must guarantee proper sample and data quality, legal and ethical compliance, as well as open (where possible) and transparent access methods. A more effective approach would be to consider the creation of specialized, high-quality, and access-controlled infrastructure. Such a repository would use the consolidated knowledge of the past decades and lessons from other biorepositories to provide well-formulated guidance, collaborate on national and international research efforts, and contribute to global security.

O2 Decarbonization Strategies at MRC/UVRI and LSHTM Uganda Research Unit Biobank

P. Babirye

Biobank, MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Wakiso, Uganda

Statement of the Problem: Due to their heavy equipment utilization and reliance on ultra-low-temperature storage, biobanks are resource-intensive facilities that contribute significantly to energy consumption and carbon emissions. Reducing these operations’ environmental impact is crucial to lowering carbon footprints and achieving global sustainability goals.

Proposed Solution: The MRC/UVRI biobank has implemented a multi-strategy approach to decarbonization:

1)

Adjusting Storage Temperatures: Increasing the temperature of ultra-low freezers from −80 C to −70 C to achieve substantial energy savings without compromising sample quality.

2)

Participation in the Global Freezer Challenge: Competing to optimize freezer management and reduce energy use.

3)

Waste Management Initiatives: Implementing proper segregation of waste and recycling whenever feasible to minimize environmental impact.

4)

Involvement in Energy and Carbon Management (ECM) Group: Collaborating within MRC’s ECM group to ensure sustainable energy practices across the unit.

5)

Decommissioning Outdated Equipment: Phasing out old, energy-inefficient equipment to reduce overall power consumption.

6)

Raising Staff Awareness: Conducting training sessions to promote awareness and active participation in decarbonization efforts among employees.

7)

Digitalization: Phasing out of paper records and going for electronic documentation and interfacing of systems to reduce use of paper.

Conclusions: The implementation of these strategies has led to observable energy reductions. Ongoing efforts, combined with staff engagement, staff behavioral change, and continuous assessment, will ensure long-term success and serve as a model for other biobanks aiming to implement similar programs.

O3 Current Practices, Barriers, and the Drive for Global Partnerships in LMIC Biobanks: A Comprehensive Qualitative Survey Project

E. Tuboly^{1, 2}, K. Sargsyan^{2, 3}

¹Hungarian Pediatric Oncology Network, Budapest, Budapest, Hungary, ²Medizinische Universitat Graz, Graz, Steiermark, Austria, ³Cedars-Sinai Medical Center, Los Angeles, California, United States

Background: There has been a recent surge in the establishment of human biobanks in low- and middle-income countries (LMICs), yet several regions have received limited attention in the literature. In this survey project, we aimed to explore the detailed views of LMIC biobank professionals regarding their current operations, barriers, and perspectives on collaboration.

Methods: A 13-item questionnaire was designed to comprehensively assess the professionals’ general and pediatric biobanking activities, the related operational challenges and needs, and their willingness and potential for collaboration with international biobanking and non-governmental organizations (NGOs). The link to the survey was distributed via emails, LinkedIn direct messages, and through relevant professional groups and platforms between August and December 2024.

Results: The survey received responses from 85 participants (30% response rate) representing 66 primarily disease-associated institutions in 41 LMICs across five global regions: Europe and Eurasia, Asia, the Arab world, Sub-Saharan Africa, and Latin America and the Caribbean. Collection practices varied, with 52.4% of the participants collecting both pediatric and adult samples and data and only two participating institutions having pediatric-specific collections. Compliance with international quality standards seemed uneven, with 52.9% of participants adhering to ISBER Best Practices, 32.5% following the IARC Minimum Technical Requirements, and 28.8% reporting adherence to ISO 20387. The most significant hurdles, as expected, were financial and infrastructural limitations (89% - 69.6%), but notably, 57.3% mentioned the lack of educated professionals as a major issue. Additionally, 74.4% of respondents expressed an interest in joining international biobank organizations for support, while 78% and 63.4% indicated desirable partnerships with other established biobanks and international NGOs, respectively. However, the latter showed particularly high regional variability.

Conclusions: Biobanking facilities are emerging in all lower-resource regions worldwide, though challenges persist in areas such as infrastructure development, quality assurance, addressing regulatory and societal issues, staff capacity building, and recruiting minors. Enhanced collaboration with international NGOs and biobank organizations is widely regarded as desirable to tackle these barriers, particularly through education and training opportunities.

O4 Establishing Key Performance Indicators to Enhance Biorepository Operations and Quality Management

N. Jawaid¹, J. Aijaz^{1, 2}

¹Biorepository, Indus Hospital & Health Network, Karachi, Pakistan, ²Molecular Pathology, Indus Hospital & Health Network, Karachi, Sindh, Pakistan

Statement of the Problem: Biorepositories face multiple operational challenges including inefficiencies in sample retrieval, temperature fluctuations, contamination risks, and data inconsistencies. These issues can impact overall biobank performance, compliance with international standards, and the quality of resources provided to researchers. Without structured performance metrics, these challenges threaten biobank reliability, accreditation, and quality standards adherence.

Proposed Solution: To address these challenges, a Key Performance Indicator (KPI) framework was developed to monitor and improve biorepository operations. This framework includes indicators across critical areas: (1) specimen processing times and retrieval accuracy, (2) temperature monitoring and control measures, (3) contamination rate tracking, (4) data accuracy in information systems, (5) storage space utilization, (6) staff competency and trainings, (7) KPIs incident reporting time, and (8) specimen request reporting time. Each KPI was selected to align with best practices and regulatory requirements, serving as benchmarks for ongoing performance and identify areas for improvement.

Conclusion: Implementing a structured KPI system in biorepository settings has enabled measurable improvements in quality, efficiency, and compliance. This approach ensures systematic tracking of operations, enhance continuous improvement, and supports accreditation efforts. By monitoring these KPIs, other biorepositories can also better address operational issues, ultimately enhancing their value and reliability as research resources.

O5 The 10 × 10 Partnership Project with Low- and Middle-Income Countries to Access Representative Human Samples through the Virtual Biorepository System

J. Giri¹, Z. Steinberg¹, A. Price², M. C. Chu¹, 10 × 10 Working Group¹

¹Center for Global Health, Colorado School of Public Health, Aurora, Colorado, United States, ²Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, United States

Problem: Access to well-characterized quality sample collections and associated data representative of global diversity is a key need for research, diagnostics, and vaccines. A trusted, sustainable resource of such samples remains unrealized, and the need is evident each time a new outbreak emerges. Reactive background of a market-approved serology test kit, calibrated against samples from European donors, can have significant performance differences when used in a low- and middle-income (LMIC) setting. Access to a representative reference background panel could ascertain how that test will perform in its new setting, saving money and averting misdiagnosis.

Solutions: The Virtual Biorepository System (VBS) was developed as a grassroots approach, based on global consultation with biobanking, scientific, and public health experts, as well as manufacturers, as a flexible system to provide efficient access to qualified samples. These consultations shaped the design of a coordinated system of locally managed collections in sites willing to share samples and build biobanking and laboratory testing capacities. Ten globally distributed LMIC members with variable biorepository capacity have joined with agreement for to each collect 10 large volume samples from 10 individuals (hence the 10×10). The 10×10 is tasked with developing governance, identifying benefits, and addressing sustainability. To work together, we needed to obtain consensus working definitions due to differing uses of “biobank and biorepository” among members. We also had to find a common definition of what is a “healthy control.” A respectful and transparent process was developed to resolve these differences so that we can proceed with the project.

Conclusion: Our project aims to test a biobanking paradigm for collecting samples for public health use and disease priorities. We are working to build trust and confidence towards filling the gap as a reliable resource to access specimens. We are carefully addressing each potential barrier to develop model exchange methods, address them together as barriers are encountered, and putting in place practical solutions. There are many potential partners who could be recruited to join this global good effort that can give access to reference samples in compliance with international regulations and ethical use while provide benefits to the contributing partner. Our vision is to expand the 10×10 incrementally with hopes of building a better pathway to sharing specimens.

O6 10 Years of BCNet: Opportunities, Challenges and LMIC-Specific Experiences in Biobanking

M. Henderson³, E. Caboux¹, S. Villar¹, R. Lawlor², Z. Kozlakidis¹

¹International Agency for Research on Cancer, Lyon, Rhône-Alpes, France, ²Universita degli Studi di Verona, Verona, Veneto, Italy, ³National Institutes of Health, Bethesda, Maryland, United States

Statement of the Problem: BCNet, or the Biobank and Cohort Building Network, is a global initiative led by the International Agency for Research on Cancer (IARC), created in late 2013, to support low- and middle-income countries in establishing and improving biobanks. The network facilitates knowledge sharing, provides training, and promotes ethical standards to strengthen biobanking infrastructure and practices. By connecting researchers and institutions globally, BCNet aims to enhance collaborative studies on cancer and other diseases, addressing local health challenges with a global perspective. The initiative is particularly impactful in regions with limited resources, where it supports sustainable biobank development to drive public health research and improve healthcare outcomes.

Proposed Solution: BCNet has created a robust network of biobanks and institutional facilities (54 from 25 countries as of November 2024), who all try to align towards harmonised protocols in sample collection for cancer research and associated data collection. The poster presents the BCNet activities and the impact they have had over the years.

Conclusion: BCNet has significantly enhanced biobanking capacity in low- and middle-income countries, enabling these regions to participate in global research on cancer and other diseases. By providing training, resources, and a collaborative network, BCNet empowers local researchers to generate valuable data that can shape public health strategies and improve healthcare outcomes worldwide.

O7 Development of REDCap Decision Support Tool for Large-Scale Return of Genetic Results

N. Larson¹, J. Bidwell², K. Kolbert², J. Olson¹, J. Bublitz¹, R. Gupta¹, J. Cerhan¹

¹Quantitative Health Sciences, Mayo Clinic Minnesota, Rochester, Minnesota, United States, ²Center for Individualized Medicine, Mayo Foundation for Medical Education and Research, Rochester, Minnesota, United States

Statement of the Problem: The Mayo Clinic Biobank received whole exome genetic data on 53,000 participants. Our current policy mandates the return of clinically actionable results, specifically pathogenic or likely pathogenic variants in the 78 genes identified by the American College of Medical Genetics, along with select genes from the National Comprehensive Cancer Network. However, the process of notifying participants, scheduling genetic counselor (GC) visits, and preparing individuals for the appointments is both complex and costly. With an estimated returnable result frequency of 4%, approximately 2,120 participants will need to be contacted. To efficiently work through this process with all eligible participants within a reasonable timeframe, we sought to develop a solution that is accessible, cost-effective, and minimizes staff effort per participant.

Proposed Solution: To streamline the process of contacting participants and scheduling GC visits, we implemented a decision-support tool using the free REDCap software. A personalized link to the tool is distributed to participants via email two weeks after an initial notification letter is sent via US mail. The REDCap is designed as a conversational decision tree that offers basic genetics education, allows participants to input their personal and family health history, and prompts them to schedule their genetic counseling phone appointment. The advantages of this approach include its security as an internal database, accessibility for the 93% of participants with email addresses, and the flexibility provided as a database that can be fully modified to fit the needs of each project. This method enables participants to read through the materials at their own pace, preparing participants for their appointment by providing insights into what to expect during their GC visit. By incorporating a medical history section, genetic counselors can better tailor their discussions based on participant backgrounds. To ensure a positive experience for our participants, a follow-up survey is sent immediately after tool completion to gauge user satisfaction.

Conclusions: This method is currently being utilized for our participants, and we plan to expand its application to return easily managed clinical conditions, such as Biotinidase Deficiency (BTD), to participants without necessitating a GC visit. This approach not only enhances participant engagement but also optimizes resource utilization within our biobank operations.

O8 Impact of Local Engagement Funding in the Cancer Moonshot Biobank

J. W. Wanyiri¹, S. McDermott¹, H. Ellis³, M. Samant², L. Agrawal², H. Moore²

¹Leidos Biomedical Research Inc., Frederick, Maryland, United States, ²National Cancer Institute, NIH, Bethesda, Maryland, United States, ³Biobanking Without Borders LLC, Durham, North Carolina, United States

Background: The Cancer Moonshot Biobank project aims to accelerate cancer research by collecting longitudinal biospecimens and health data from cancer patients nationwide. A key component of this initiative is providing dedicated funding for investigator-initiated local engagement projects. These funds are intended to bolster participant and provider engagement to help foster representation from people with diverse demographics and build trust within communities, particularly those historically underrepresented in clinical research. The approach aims to promote better communication and transparency, ensuring participants understand how their contributions support research and, ultimately, improve enrollment and retention rates and diversity in the Biobank.

Method: Funded activities at clinical sites included supplementing the salaries of dedicated clinical research associates (CRAs), creating and distributing educational materials, training healthcare providers, identifying and supporting physician champions, and conducting community outreach. To evaluate the impact of this funding, we compared study outcomes from funded sites to those from sites that did not receive funding.

Results: Clinical sites that received engagement funding demonstrated notable improvements in participant enrollment and retention. Funded sites have attained higher enrollment rates than those without engagement funding (61% vs 39%). Additionally, they achieved higher enrollment of minority participants, specifically Black or African American individuals (16.9% vs13.8%), higher adoption rates of electronic consent (20.7% vs 15.9%), and greater collection rates of fresh biopsies (57% vs 43%). Providing partial funding for dedicated CRAs has had a substantial impact on increasing participant enrollment and retention, suggesting that personalized interactions and coordination are pivotal in participant screening, recruitment, and enrollment.

Conclusion: These findings demonstrate that dedicated resources and targeted participant, provider, and community engagement efforts are essential for enhancing biobank participant enrollment and retention, ensuring quality biospecimen acquisition, improving representation and diversity, and ultimately accelerating cancer research progress and improving the ability to develop effective treatments that benefit diverse populations.

O9 A Biobanking Legacy: The Impact of Post-Mortem Biobanking Programs

C. Griffin¹, M. Carlson¹, M. Walker¹, J. Lynam², C. Paul¹

¹The University of Newcastle, Callaghan, New South Wales, Australia, ²Medical Oncology, Calvary Mater Newcastle, Waratah, New South Wales, Australia

Post-mortem brain donation provides insight into pathogenesis for brain cancer as well as spatial and temporal heterogeneity beyond what a surgical biopsy can afford. Post-mortem biobanking programs are increasing in number. Therefore, it is imperative that biobanking professionals understand the human experience associated with brain donation protocols to ensure benefit is maximised and harm minimised.

We interviewed 27 next-of-kin (NOK) following the death of their loved one and subsequent donation to the Mark Hughes Foundation (MHF) Biobank and 13 NOK at the time of consent. A thematic analysis based on the work of Braun and Clark was carried out on the transcribed, qualitative interviews and the identified themes presented with a narrative synthesis.

Themes included; 1: “We were just doing it, that’s it!” – Brain donation is a decision grounded in altruism and pragmatism, 2: “I didn’t feel helpless” – supporting donors is a source of comfort, pride, and empowerment, 3: “His death has had some sort of purpose” – Brain donation can provide meaning for suffering and tragedy, and 4: “I can still remember the zipping up of the bag” – perceptions of procedures and processes. These themes represent that brain donation can be an instinctive decision grounded in pragmatism, which provides a sense of comfort while assisting in making meaning for loved ones. We also obtained insight into areas in need of improvement; for example, the process for removal of the donor in the event of a home death and the role of the body bag.

Our data indicate that supporting a loved one to donate their brain can be a positive experience providing a source of hope, empowerment, and purpose. This adds an entirely new dimension to the biobanking value spectrum and one that is worthy of further exploration. Data indicating areas for consideration will be utilised to improve delivery of the program for future donors and their loved ones.

O10 Setting up a Bacteriophage Biobank to Support Phage Therapy

K. Kabo², S. Paley¹, N. Dufour³, B. Gaborieau⁴, O. Clermont⁵, F. Betsou¹, O. Chesneau¹, M. L. Ferrari¹, D. Clermont¹, L. Debarbieux³

¹CRBIP, Institut Pasteur, Paris, Île-de-France, France, ²Institut Pasteur Dakar, Dakar, Senegal, ³Institut Pasteur, Paris, France, ⁴APHP, Paris, France, ⁵IAME Université Paris Cité, Paris, France

Background: Bacteriophages are viruses infecting bacteria. Their use to treat bacterial infections was proposed by Félix d’Herelle over a century ago but was disregarded after introduction of antibiotics. Nowadays, phage therapy is regaining interest supported by successful personalized treatments of patients infected by antibiotic-resistant bacteria. Access to controlled resources of well-characterized bacteriophages is one of the main hurdles delaying implementation of phage therapy. Here we report on the early steps of building a bacteriophage biobank at Institut Pasteur.

Methods: We set up a dedicated laboratory area for bacteriophage preparation and characterization. We chose a commercial Biobank Information Management System (MBIOLIMS, ModulBio, France) for the management of both bacteria and bacteriophage collections. We compared two phage titration methods and wrote all applicable preparation and characterization standard operating procedures (SOPs).

Results: A new instance of MBIOLIMS for bacterial strains, including specific taxonomy modules, has been developed and validated. We then configured the MBIOLIMS with specific data fields for bacteriophage collections. Moreover, available SOPs for bacterial strain culture, complete genome sequencing, and MALDI-TOF characterizations and strain storage were completed by new SOPs for bacteriophage procedures: amplification, titration, concentration, and DNA extraction. In particular, we compared the reference method for titration using double agar overlay to the spot deposit plaque assay, which is more rapid and can be performed by liquid-handling robots. Using three pairs of bacteriophages and bacterial strains, our preliminary results indicated very similar titers. The next step is to start the acquisition of the first Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii strains serving as hosts for the corresponding bacteriophages available from academic and clinical laboratories.

Conclusion: Professional bacteriophage biobanks represent a new resource for personalized treatments against infections by multi-drug resistant bacteria. The bacteriophage biobank aims to provide starting materials to manufacturers and clinicians to further implement phage therapy.

O11 Validation of Dual Needle Core Biopsy Device

R. Ackroyd^{1, 2}

¹BioBankBuilders, LLC, Windham, Maine, United States, ²BioMedical Science, Quinnipiac University School of Health Sciences, North Haven, Connecticut, United States

Background: Tissue acquisition is the fundamental mission of biorepositories, yet many cancer cases are unable to be banked due to small tumor size and inadequate tissue availability. As diagnosis is the first priority, core biopsy samples are rarely if ever sacrificed for banking.

With this challenge in mind, a prototype dual needle core biopsy device has been developed, which takes two directly adjacent samples from a tumor, thus providing sufficient tissue to address the needs of diagnosis and, as well, ancillary studies and biobanking.

A recent validation study has confirmed the utility of this new dual needle core biopsy device. Study findings from the microscopic examination of both cores proved diagnostically equivalent tissue. This allows for one core for diagnosis and one for banking. The technology enables the collection of additional research tissue historically unattainable—added tissue that has the potential to accelerate new discoveries by the academic, commercial, and research communities.

Methods: The study utilized 30 residual formalin-fixed surgical pathology cancer cases slated for discard per the participating hospital tissue retention policy. The cases were tested with a 17g dual core biopsy device. Both cores were submitted in a single cassette for routine histology processing and subsequently reviewed for quality and concordance of diagnostic histology.

Core samples were evaluated by a pathologist for consistency and representation of the pair of samples. The two cores were scored for the consistency in:

1)

Presence or absence of tumor.

2)

Percentage of tumor of each sample (when present).

3)

Presence of inflammation.

4)

Presence of fibrosis.

5)

Presence of necrosis.

6)

Presence of normal histology.

Results: This study showed that a dual needle core biopsy device could acquire “equivalent” core samples of cancer tissue in a single pass. The technology preserves the ability to diagnose, as well as support research, especially when tissue samples are limited. The device also allows triaging core samples taken from tumors for the most appropriate testing or research. Because tissues were verified for disease, only verified diseased tissues were sent for testing; the technology ensured that tissue sent for ancillary tests had the most accurate results.

Conclusions: The device has the potential to accelerate medical discoveries by making more tissue available to biorepositories without compromising a patient’s diagnosis.

O12 The CHAMPS Biorepository: Building Quality Biorepository Capacity in LMICs

M. Alam², V. Bailey³, A. Benedito⁴, F. Kabir⁵, I. Mandomando^{6, 7}, D. Marami⁸, J. Ojulong⁹, C. Onyango¹⁰, D. Suleiman¹², S. Tennant¹¹, U. Udoh¹³, K. Maher¹, D. Blau¹⁴, J. Giri¹, S. Child Health and Mortality Prevention Surveillance (CHAMPS)¹

¹CHAMPS, Emory Global Health Institute, Emory University, Atlanta, Georgia, United States, ²Infectious Diseases Division, International Center for Diarrhoeal Diseases (icddr,b), Dhaka, Bangladesh, ³Vaccines and Infectious Diseases, South Africa Medical Research Council, University of Witwatersrand, Johannesburg, South Africa, ⁴Centro de Investigação em Saúde de Manhiça, Manhiça, Maputo, Mozambique, ⁵Pediatrics and Child Health, Aga Khan University, Infectious Diseases Research Laboratory (IDRL), Karachi, Pakistan, ⁶Centro de Investigação em Saúde de Manhiça, Manhiça, Maputo, Mozambique, ⁷Natonal Institute of Health, Ministry of Health, Manhiça, Mozambique, ⁸Haramaya Univesrity, College of Health and Medical Sciences, Harar, Ethiopia, ⁹CHAMPS Laboratory, Makeni, Sierra Leone, ¹⁰Kenya Medical Research Institute, Center for Global Health Research (KEMRI-CGHR), Kisumu, Kenya, ¹¹Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, United States, ¹²Dept. of Histopathology, College of Medical Sciences, Abubakar Tafawa Balewa University, Bauchi, Nigeria, ¹³University of Calabar, Calabar, Cross River, Nigeria, ¹⁴Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, United States

Background: The Child Health and Mortality Prevention Surveillance (CHAMPS) Network was established as a long-term collaborative platform to conduct surveillance in areas of sub-Saharan Africa (seven sites) and Southeast Asia (two sites) with high child mortality. CHAMPS teams collect specimens from stillbirths and deaths in children under five using minimally invasive tissue sampling (MITS) and perform extensive testing to accurately determine causes of deaths. Specimen collection procedures generate aliquots that are available for future investigations and are kept in the CHAMPS Biorepository, established in 2016.

Challenges and Solutions: The multi-site network and unique specimen types presented some challenges, such as: ensuring site representation and contribution to governance; standardization of specimens and associated data; few or incomplete sets of specimens available for each case; potentially infectious specimens; and logistics of sharing. The governance aimed to address these challenges by forming a Specimen Access Working Group (SAWG) that enabled members from each site to participate in decisions regarding the use of specimens. The SAWG developed policies to ensure equitable access and compliance with ethical and legal requirements and wrote protocols, standard operating procedures, and guidance documents to support standardization, quality, and biosafety.

Researchers frequently request specimens from multiple sites for their studies, and asking individual sites to respond would have been a taxing burden. A working solution was developed: half of the specimens are preserved locally, and half are shipped to a central location, the Centers for Disease Control and Prevention Biorepository. Specimens stored at the central location are the primary specimens used for sharing with external investigators and specimens kept locally allow each site to develop new laboratory methods and initiate their own research collaborations.

Conclusions: Several successful studies using CHAMPS biorepository specimens have validated the approach and demonstrated the unique value of having CHAMPS specimens linked to detailed case-level clinical information. A lesson learned is the need for a more robust inventory system that can accommodate growth. Availability of well-managed biorepositories that can maintain specimens safely and securely will have an important and lasting impact on research and capacity development at CHAMPS sites and for external researchers whose work will benefit from these specimens.

O14 An Innovative and Quantitative Tool for Culling Collections of Human Specimens; Multi-Institutional Proof of Concept

I. El Idrissi², V. Piquard¹, W. Fransman², E. Roux¹, C. Mauriac¹, F. Betsou¹

¹CRBIP, Institut Pasteur, Paris, Île-de-France, France, ²FIND, Geneva, Switzerland

Background: Long-term storage in biobanks incurs significant costs linked to space and energy consumption. Institutional strategies may change over time, while significant volumes of historical collections may remain unused. Regular evaluation and culling are essential for sustainability, yet deciding which samples to discard remains challenging, as most biological materials of human origin are non-renewable. This study presents an innovative, quantitative Culling Tool, collaboratively adapted by FIND Specimen Bank and the Biological Resource Center of Pasteur Institute Paris (CRBIP).

Methods: We developed a Culling Tool to help establish culling plans. The originally developed tool includes 18 variables scored individually for each collection and specimen type combination, and the total scores range from 0 to 37. FIND and CRBIP adapted it to their particular contexts: FIND Specimen Bank as an infectious disease biobank whose primary objective is to support development and validation of diagnostics, and CRBIP as an institutional biobank whose primary objective is to support institutional research. Evaluation of the Culling Tool results was performed at CRBIP against independent review of collections and a cut-off value could be established. This threshold ensures optimal sensitivity and specificity of the culling tool in “diagnosing” collections to be culled.

Results: FIND’s adaptation of the Culling Tool resulted in a streamlined version with only nine variables, producing final scores from five to 41. CRBIP tailored the tool to include 13 variables, with final scores ranging from -15 to 58. FIND applied the tool to 182 collections, leading to the culling of over 35 collections, equivalent to approximately 60,000 samples, and saving the capacity of one –80 C freezer, valued at $12,000 per year. Similarly, CRBIP utilized the tool on 44 collections including 201 collection/specimen type combinations. We achieved the removal of 82 collection/specimen type combinations (equivalent to approximately 60,000 samples), saving the capacity of two –80 C freezers and 1/4 liquid nitrogen tank. At the cut-off value of 11, the “diagnostic” sensitivity and specificity for detecting “cullable” collections were 99% and 63% respectively.

Conclusions: The Culling Tool represents an innovative and quantitative approach to culling collections of human specimens. It guides informed culling decisions and represents a scalable and adaptable solution supporting sustainable biobank management.

O15 Institutional Conversion to Energy-Efficient Ultra-Low Freezers Decreases Carbon Footprint and Reduces Energy Costs: Methods and Results

D. Shehu

University of California San Francisco, San Francisco, California, United States

Background: The storage of biospecimens is a substantial source of greenhouse gas emissions and institutional energy costs. Energy-intensive ultra-low temperature (ULT) freezers used for biospecimen storage are a significant source of carbon emissions. ENERGY STAR-certified ULT freezers have the potential to decrease the carbon footprint. We present methods and quantify the impact of an institutional-scale freezer conversion program on carbon emissions and energy costs.

Methods: A ULT freezer energy use prediction model was developed to identify and replace the most inefficient freezers for this pilot, and eventually institution-wide. Multiple linear regression factors included the number of years of use, storage volume, and ENERGY STAR certification status. Electrical usage and carbon emissions were quantified before and after replacement with ENERGY STAR models. Novel models for energy and cost forecasting were developed that incorporate findings from previous work to account for HVAC impact, mechanical decline, and energy rate increases. Logistical methods were developed to decrease the risks of exposure of frozen samples to ambient temperature during content transfers. Institution-wide energy costs were derived by converting electrical burden to electrical costs. Carbon footprint assessment from ULT freezer operation was computed using the United States Environmental Protection Agency Greenhouse Gas Equivalencies Calculator.

Results: The pilot project revealed an annual reduction of 310,493 kilowatt hours of electrical usage, equivalent to 134 metric tons of carbon emissions. Annual electrical costs were reduced by $55,889, resulting in an eight-year payback on the initial investment. Using the pilot results, we modeled the benefit of the freezer exchange across the entire institution: conversion of the institution’s remaining 1,119 conventional ULT freezers to ENERGY STAR models would lower annual electrical usage by 7,911,549 kilowatt hours (3,423 metric tons of carbon emissions), resulting in savings of over $1.4 million annually.

Conclusion: Our models were the basis for a compelling business case to invest in converting University of California San Francisco’s entire ULT freezer fleet to ENERGY STAR freezers. Our methods make a large-scale initiative to replace energy-inefficient ULT freezers logistically possible, reduce carbon footprint, and demonstrate an attractive return on investment while proactively protecting valuable research materials.

O16 Understanding Decarbonization and Environmental Sustainability Practices in the Global Biobanking Landscape

N. Rastegar, T. Sildva, M. Ghany, H. Wagner

Biospecimen Services, University Health Network, Toronto, Ontario, Canada

Background: An increase in atmospheric CO2 not only impacts climate change and resource scarcity but is also a public health risk, increasing the distribution of pathogens globally. Implementing carbon footprint reduction is essential across industries and biobanks are no exception. Despite knowledge of adverse environmental impacts of conventional biobanking practices, these concerns are not prioritized and there is a need for a culture shift in biobanking operations to improve resource sustainability and decarbonization efforts. To facilitate development of standardized environmental sustainability guidelines for biobanks, the Biospecimen Services Program at the University Health Network (UHN-BSP) aimed to understand the current state of sustainable biobanking practices globally.

Methods: UHN-BSP, in collaboration with Université Côte D’Azur Biobanks & Complex Data Management Program, developed a web-based survey in 2024. The survey comprised 30 questions focused on facility design, infrastructure, current sustainable practices, digital footprint, and participant interest in environmental sustainability. The questionnaire was disseminated through national networks across Canada and internationally through the ISBER forums. The participants were de-identified and quantitative and qualitative approaches were used to analyze the responses.

Results: Over 30 biobanks across 10 countries and five continents completed the questionnaire. The repositories ranged from three to 35 years old across a wide range of facilities, collection sizes, and specimen types. Sustainable practices employed included the use of LED lighting, paper recycling practices, and the use of energy-efficient freezers. However, an overwhelming majority of the institutions (53-70%) consistently responded that there are no energy saving or sustainability initiatives such as freezer disposal plans or sustainable consumables use. Only one biobank had any environmental sustainability certifications. Nevertheless, over 70% of the participants expressed interest in implementing these practices and accessing resources to assess their carbon footprint.

Conclusion: This questionnaire reveals the need to explore challenges facing biobanks globally in implementing sustainable practices. The interest in the application of decarbonization guidelines is overwhelming. This snapshot of the global biobanking landscape can aid in developing environmentally sustainable best practice policies internationally.

O17 Blockchain-Based Universal Identifiers for Biobank Sample Tracking in Canada

S. Sion¹, T. Nguyen-Phan², M. Fortin³, A. Mes-Masson^{4, 5}, K. Zhang¹

¹Software and IT Engineering Department, École de technologie supérieure, Montreal, Quebec, Canada, ²The University of British Columbia School of Library Archival and Information Studies, Vancouver, British Columbia, Canada, ³Université de Québec Montréal École des sciences de la gestion, Montreal, Quebec, Canada, ⁴Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, ⁵Université de Montréal Faculté de médecine, Montreal, Quebec, Canada

Problem Statement: Biobanks play a fundamental role in supplying researchers with biological materials, but they are confronted with a major challenge: the inability to track samples once they leave their facilities. This lack of transparency has three major consequences: loss of sample history after external transfers, unverified sample origins in scientific publications, and unauthorized sharing between researchers without biobank consent. Current management systems and efforts like national biobanks and data standards fail to provide consistent monitoring and control across institutions.

Proposed Solution: Blockchain’s inherent transparency and security make it ideal for this challenge. We propose a universal identifier system based on blockchain technology to address the traceability issues around shared biospecimens. This solution ensures the full history of each sample is accessible, verifies sample origins in publications, and prevents unauthorized sharing, supporting transparency and reproducibility. The system includes: a unique identifier for each sample; a permissioned blockchain offering immutability, decentralization, and transparency; smart contracts for sample registration, transfers, and updates; a secure application program interface for integration with an existing biobank inventory management system; a role-based access control system for data confidentiality and security; and an identifier resolution mechanism for efficient information retrieval.

When a sample is first registered, the blockchain system generates a unique identifier. It records all transfers and updates as transactions on the blockchain. Authorized parties can also query the full history of any sample. Integration with scientific publishing will make it easy for editors and reviewers to verify sample provenance.

Conclusion: The blockchain-based universal identifier system is an innovation in biobank management and biomedical research. It can improve reproducibility, strengthen research integrity, and evaluate biobank impact more effectively. This approach also aligns with the FAIR principles. However, implementing this system on a large scale presents challenges, particularly in terms of incentivizing widespread adoption. We propose a phased deployment approach, starting with a pilot phase in collaborative biobanks using the Annotated Tissue Management platform, which is used by over 60 biobanks across Canada; the pilot will also address incentives and governance for the biobanking community.

O18 Demonstrating Biobank Efficacy through the Development of a Bibliographical Metric Tool

Z. vonMenchhofen¹, D. McGarvey¹, K. Radin², K. Montone¹

¹Pathology and Lab Medicine/CHTN, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States, ²CHTN, Indianapolis, Indiana, United States

Background: The Cooperative Human Tissue Network (CHTN) is a National Cancer Institute (NCI)-supported program dedicated to facilitating research by providing human tissue specimens. Biobanks need tools that can demonstrate to their stakeholders the success of their utilization efforts and ensure sustainability. Biobank efficacy is often assessed by references to biobank-provided samples in publications and patents, as these indicate successful downstream use. Traditionally, CHTNED employed a librarian to manually identify citations—an effort both time-intensive and costly. In response, an informatic-based bibliographical metric tool (BMT) was developed to streamline this process, reduce costs, and improve our tracking of CHTN’s impact.

Methods: BMT integrates: 1) automated data-mining using application program interface (API) feeds from scholar.google.com, PubMed’s NCBI Entrez service, and the US Patent and Trade Office (USPTO); 2) to locate references to CHTN, the tool performs Regex-based searches of publication texts, focusing on terms and phrases associated with CHTN (RRIDs, misspellings, site locations, etc.); and, 3) a custom user interface enables CHTN to review, classify, and validate these findings through a matrix of predefined categories (e.g., relevance to protocol, specific usage type, etc.). This classification not only quantifies the impact of CHTN on research outputs but also provides insights into how our resources are utilized by investigators.

Results: The BMT has enabled CHTN to replace manual citation tracking with a more cost-effective, automated solution. By improving classification consistency and operational efficiency, the tool provides an overview of CHTN’s reach and relevance in scientific literature. Preliminary analyses show that this tool reduces manual labor costs associated with reference tracking, while also expanding the scope and accuracy of efficacy metrics through the developed classification matrix.

Conclusion: The BMT demonstrates an effective, scalable approach to tracking biobank impact through bibliometric data. By automating the citation discovery and classification process, CHTN has achieved a more accurate and comprehensive assessment of its impact. This tool exemplifies how biobanks can leverage custom bibliographical metrics to strengthen funding justification, optimize resource allocation, and gauge the impact of their footprint in the research community.

O19 A New Paradigm for the Biorepository: Providing Novel Solutions for Multiomic Analysis of Samples Collected for Research into the Genetics of Human Disorders

M. Sheldon¹, Y. Ding², J. Schultz², S. Nahas²

¹Scientific Affairs, Sampled, Piscataway, New Jersey, United States, ²Sampled, Piscataway, New Jersey, United States

Background: The demands of disease research, cell and gene therapy, and drug development present opportunities for biorepositories to serve the global research community in new and important ways. Advances in human genetic research can be greatly facilitated by integrating analytical laboratory operations with accredited biobanking facilities generating and maintaining genetic resources such as the National Institute on Drug Abuse (NIDA) Center for Genetic Studies (NCGS). The model of such an integrated analytical biorepository is exemplified by the NCGS at Sampled. While the NGCS and other collections were conceived as cell, DNA, and clinical data resources designed to facilitate cost-effective sample sharing among researchers, at Sampled they have surpassed that original mandate by providing multiomics services including long read Whole Genome Sequencing, ATAC-Sequencing, and Proteomics. We will present examples of studies for which innovative solutions were developed to ensure that investigators achieve their scientific goals while maximizing the utility of precious non-renewable biospecimens.

Methods: The first study interrogates the transcriptome and chromatin accessibility related to opioid dependence through RNA-sequencing and ATAC-sequencing, respectively. It accomplishes this by leveraging the peripheral blood mononuclear cell (PBMC) biospecimens that have been collected as blood samples, along with critical clinical and phenotypic data, for more than 20 years by participating NIDA studies, followed by processing and cryopreserved of the PBMCs at the NCGS. The biorepository played a critical role in developing a novel workflow for performing ATAC- and RNA-Seq, as well as MS-based proteomic analysis, from a single vial. In this presentation, we will describe the development of the workflow and its impact on specimen and data quality.

We will then present a second study, which utilizes a new workflow based on long-read RNA sequencing, for the identification of novel RNA isoforms. This is achieved by leveraging the lymphoblastoid cell lines we created and now store as part of the Simons Simplex Collection project. In this instance, Sampled collaborated with the research investigator as well as a technical partner to advance our understanding of the molecular basis of autism spectrum disorder.

Conclusion: These case studies represent a new model for the biorepository in human disease research, as both the guardian of precious genetic resources, and a partner with the researcher in designing strategies that yield important insights.

O20 Tissue Portal: A Case Study in Biobank Support via Derivatization Core Facilities

I. Lungu¹, J. Li¹, A. Dimbleby¹, A. Albano¹, K. Samms¹, A. De Luca¹, L. Liao¹, C. Crozier¹, M. Quintayo¹, D. Dion¹, M. Hopkins¹, S. Barker¹, M. Spears^{1, 2}, D. Chadwick^{1, 2}, J. Bayani^{1, 2}

¹Ontario Institute for Cancer Research, Toronto, Ontario, Canada, ²University of Toronto, Toronto, Ontario, Canada

Statement of the Problem: Biobanks have increasing demand to make high-quality biospecimens available to meet evolving research needs. Industry-sponsored and academic researchers require rapid access to samples in formats optimized for complex analyses, such as next-generation sequencing (NGS) and AI-driven digital spatial pathology. Disease-focused biobanks, sitting at the threshold between bedside and bench, may struggle to support these needs due to the significant infrastructure and personnel investments required to establish such in-house capabilities.

Proposed Solution: Derivatization cores, such as our Diagnostic Development (DD) Program’s Tissue Portal (TP) team, meet this challenge. Our team offers centralized facilities and expertise needed for high-throughput processing, dedicated to the customization of biospecimens for complex assays. Operating within the Ontario Institute of Cancer Research’s Molecular Oncology Core Research Resources, our laboratory is CAP, CLIA, and ACD accredited, allowing biobanks to offload tasks like nucleic acid preparation and slide digitization. This reduces pressure on clinical labs, allowing them to focus on core medical duties, while still allowing for research samples to be processed with the same quality management expected in a clinical setting. Robust workflows support studies needing bespoke services to achieve their research goals. Our team, established in 2018, supports the Ontario Tumour Bank and numerous correlative sciences repositories. We demonstrate a sustainable model for this mutually beneficial partnership, processing and distributing over 10,000 samples annually across a multitude of biospecimen requests.

Conclusions: Derivatization core facilities are complimentary to biobanking operations, helping to meet the growing needs of specialized research. Offering sample processing services suitable for various -omic applications, DD’s TP helps biobanks improve operational efficiency and broaden sample availability. By bridging the gap between specimen collection and complex assays, successfully interfacing with both specimen repositories and those emerging and evolving technologies such as NGS and AI-driven pathology, derivatization cores significantly contribute to the research lifecycle. In this way, we support the important work that brings bedside samples to the bench-top and innovation back to bedside, providing long-term benefit to patients.

O21 Clinical, Biological, Imaging and Genetic Repository (C-BIG): An Integrated Approach to Biobanking in the Context of Open Science

M. Boivin¹, N. Ferry¹, P. Wang¹, A. Boulid¹, K. Lafleur¹, L. Stephan¹, J. Kwizera¹, R. Abou-Haidar², S. Das², T. M. Goldsmith³, X. Chen³, T. Durcan³, J. Karamchandani⁴

¹CBIG Repository, Montreal Neurological Institute-Hospital, Montreal, Quebec, Canada, ²Montreal Neurological Institute-Hospital, Montreal, Quebec, Canada, ³EDDU, Montreal Neurological Institute-Hospital, Montreal, Quebec, Canada, ⁴Pathology, Neurology and Neuroscience, Montreal Neurological Institute-Hospital, Montreal, Quebec, Canada

Background: The Montreal Neurological Institute’s Clinical, Biological, Imaging and Genetic (CBIG) collection and patient registry has recruited more than 4000 participants across Canada with neurological conditions as well as healthy controls since 2016. Using the web-based LORIS open-source database, the open biobank integrates patient and sample data to help scientists around the world to run cutting-edge research projects within an Open Science framework, to advance the understanding of neurological diseases and discover new therapeutic ways to help fight neurological disorders.

Objectives/Methods: The main objective is to collect de-identified biological material as well as clinical, imaging, and genetic information from patients and controls to enable innovative research projects that will advance the understanding of neurological diseases and human health under the Open Science principles.

Results: So far, C-BIG has collaborated with more than 100 academic and industrial partners. Each partner has to give a summary data report on the use of samples within an adjustable period of time if no publication has arisen. The Neuro’s C-BIG repository is using an open version of LORIS (Open Portal) for data access, including a Data Query Tool for scientists. Three different levels of access are available: Open, Registered, and Controlled.

Discussion/Conclusion: The C-BIG Repository hopes to improve and facilitate the material and data collection and sharing under the Open Science principles. The long-term goal is reinforcing the recruitment of participants across the world, by integrating the most information possible of these participants in the multimodal database to have a broader picture of neurological disorders, and accelerating research.

O22 Living Biobanks of Patient-Derived Organoids Facilitate the Promise of Precision Medicine

C. Huynh², A. Laguna², Y. Li², M. Che², Y. Zhang², V. Ramanujan^{2, 1}

¹Academic Affairs and Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, United States, ²Biobank and Research Pathology, Cedars-Sinai Medical Center, Los Angeles, California, United States

Background: Understanding of human diseases warrants a multi-dimensional approach pivoting on the existing inventory of biological models of specific human diseases. Traditional biobanks add value to these research efforts by providing high-quality, well-annotated human specimens such as formalin-fixed paraffin-embedded (FFPE) and fresh frozen tissues. However, these specimen types are not amenable to functional assays for the discovery and validation of therapeutic targets as well as assessment of drug response. To bridge this much-needed gap, living biobanks are currently being explored as viable infrastructure, thereby demonstrating a significant impact on human disease research.

Methods: We have established and validated a framework for generating patient-derived organoids (PDOs) and cell banking pipelines. By obtaining informed consent from specific patients that harbor cancer as well as other rare diseases, a detailed workflow has been developed and is being continuously streamlined to accommodate efficient generation and banking of organoids and living cells for downstream functional assays. High-resolution 3D fluorescence imaging and image analytics protocols further accentuate the characterization of the PDOs probed with clinical markers. We are currently building an in-house partnership for RNA-sequencing of the PDOs to identify drug targets and expediate precision medicine workflows.

Results: By seamlessly integrating the clinical, pathology, imaging, and immunohistology databases for each of these PDOs, we have demonstrated a comprehensive living biobank of PDOs and living cells. This presentation will discuss the infrastructure, process, and outcomes associated with living biobanks and will demonstrate the utility of this framework with case studies in breast and other organ systems. Comparison data obtained between the two-dimensional and three-dimensional models will be presented to highlight the unique advantages of the PDOs.

Conclusions: This symposium presentation will be an exposition of our recent experimental success in establishing a living biobank focused on generating PDOs and to address the real-time challenges of recapitulating the human disease in vitro. Rare diseases that do not have viable pre-clinical models may be particularly benefited by the PDO framework. Collaborative avenues between living biobanks within ISBER may further enhance the speed with which these models can be validated in low-income countries as well.

O23 Building the Kids Eye Biobank: Structure, Governance, and Participant Consent Preferences

H. Dimaras^{1, 2}, K. Flegg¹, F. Argento¹, A. Hoffman¹, A. Mallipatna^{1, 2}

¹Ophthalmology & Vision Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, ²Ophthalmology & Vision Sciences, University of Toronto, Toronto, Ontario, Canada

Background: Pediatric ophthalmic disorders present significant challenges for research due to their low prevalence and clinical variability. We describe the development of the Kids Eye Biobank and report on participant informed consent preferences.

Methods: We developed a biobank devoted to systematic collection of pediatric ophthalmology specimens, clinical data, and images to catalyze innovative research and fill knowledge gaps. Participants are recruited from Canadian and international sites. A broad ongoing consent model is employed, enabling various types of downstream research while maintaining patient autonomy throughout their participation. Biobank governance consists of an External Oversight Committee, Patient Advocate Committee, and Material and Data Access Committee. Committees support biobank objectives and ensure ethical use of resources, outlined in a specific terms of reference document for each. Screening and informed consent logs are routinely reviewed to assess trends in consent, decline and agreement to optional components of participation.

Results: To date, 312 individuals were approached for participation, and written informed consent was obtained for 276 (∼88.5%). Substitute decision-makers consented on behalf of the participant in most instances (79%, 218/276). Pediatric eye conditions represented malignant (174/276, 63%) and benign (51/276, 18%) neoplasms as well as other disorders of the eye (49/276,17%). Participant informed consent preferences for the optional components on the use of biobank resources varied, with higher interest in using whole genome sequencing (WGS) data in future studies (94%; 261/276) and creating cell lines or organoids (91%; 250/276). However, willingness to share resources with industry was lower (78%; 217/276). Opt-in for notification of clinically actionable secondary findings remained high (94%; 259/276). Diagnosis of malignant neoplasm predicted opt-in to WGS data use and cell lines/organoid research.

Conclusions: The Kids Eye Biobank is positioned to catalyze innovative research through systematic collection and sharing of specimens, data, and images. The integration of patients into the governance model builds public trust and promotes sustainability, evidenced by high patient participation and involvement. Further examination of consent predictors may reveal methods to increase acceptance of opt-in choices.

O24 Custom Prospective Fresh Tumour and Blood Procurement from the Ontario Tumour Bank (OTB): Supporting the Next Generation of Precision Medicine Initiatives

R. Cox¹, C. Shire², J. Petzke², K. Maksimovic¹, L. Phouthavongsy¹, I. Lungu¹, D. Chadwick^{1, 3}, L. Stein^{1, 3}, J. Parfitt^{2, 4}

¹Ontario Tumour Bank, Ontario Institute for Cancer Research, Toronto, Ontario, Canada, ²London Health Sciences Centre, London, Ontario, Canada, ³University of Toronto, Toronto, Ontario, Canada, ⁴Western University, London, Ontario, Canada

Background: OTB has historically provided samples for research that have been stored frozen or fixed. Recently, OTB has received a steadily increasing demand for fresh, viable tumour and blood samples to support advanced precision medicine research. Fresh tumour and blood samples have many applications, such as creating patient-derived (PD) models (PDOrganoids/PDXenografts) and supporting AI-fueled drug discovery and assay development.

Methods: Biobanking fresh samples poses several challenges. These include complying with research ethics requirements for living PD models; obtaining consent pre-operatively; ensuring fresh sample collection prioritizes patient care and does not impact OTB’s retrospective collection; preserving samples in customized media; maintaining sample temperature between 2-8 C during transport; and confirming delivery to the client within 24 hours. OTB mitigated these challenges by amending its ethics protocol and informed consent forms; targeting cases where pre-operative chart review (diagnostic imaging and prior biopsy) indicated a large malignancy; prioritizing a portion of each sample for OTB’s inventory; establishing online communication tools for rapid communication of case availability between the hospital team, OTB client coordinator, and research clients; developing protocols for fresh sample collection, processing, and shipping; using temperature-regulating shipping devices; and scheduling shipments using couriers’ highest service tier available.

Results: After the successful pilot of fresh tumour cases from one OTB partner hospital site (London, Ontario) to an American biotechnology startup, OTB is now supporting seven additional studies with custom fresh tumour and blood collections. Storing a portion of each fresh sample type distributed ensures that OTB’s retrospective collection continues to grow and support future research studies.

Conclusions: OTB is one of the few comprehensive solid tumour banks in North America, and demand for high-quality samples and data continues to increase. Fresh tumour and blood samples are essential for many types of research, including rapid drug screening, assay development, and PD model generation. By creating a custom workflow, OTB now broadly offers prospective procurement of fresh samples to meet the growing needs of the academic and industry research communities.

Poster Session

Biobank Tools

PA-01 Setting Up a Tumour Bank at Institut Pasteur de Côte d’Ivoire

K. A. Kintossou¹, S. Coulibaly³, S. Cissé¹, M. Money¹, M. Dosso²

¹Biobank, Institut Pasteur de Côte d’Ivoire, Abidjan, Lagunes, Côte d’Ivoire, ²Department of Bacteriology and Virology, Institut Pasteur de Côte d’Ivoire, Abidjan, Côte d’Ivoire, ³Molecular Genetics Platform, Institut Pasteur de Côte d’Ivoire, Abidjan, Côte d’Ivoire

Background: Cancer is a major public health problem in Côte d’Ivoire, with high morbidity and mortality rates. Globocan 2020 estimates put the number of new cases in Côte d’Ivoire at 17,300, with almost 11,760 deaths. This is largely due to ignorance of the cancerous disease, late diagnosis in almost 75% of cases, and the poor representation of African populations in cancer genomics studies, despite the fact that Africa has the greatest genetic diversity. Consequently, we need to develop research projects focusing on African populations to identify potential biomarkers that can be used for early diagnosis, staging, therapeutic choice, and follow-up of patients. To contribute to this, it is proposed to create a tumour bank within Biobank of Institut Pasteur de Côte d’Ivoire (IPCI).

Objective: To organise collections of biological resources for the following cancers: colorectal, prostate, gastric, and breast.

Methods: This project will involve collecting, transporting, processing, storing, and distributing high-quality biological resources (blood, tissues, urine, faeces).

Results: (i) validation of procedures for collecting, transporting, receiving, processing, storing, and distributing biological resources; (ii) staff training; (iii) raising awareness in the scientific community; (iv) improved care for cancer patients.

Conclusion: The tumour bank will provide access to a wide range of samples combined with high-quality data to contribute to national and international research. Such research projects will benefit not only African populations but also the international community as a whole by enriching existing databases.

PA-02 DNA Quality Comparison of Formalin-Fixed Paraffin-Embedded Tissue and Fresh Tissue

A. Ramadan, R. Mohamed, A. M. Gamal, M. Saady, S. Aboelela, A. Saleh

Research Department, Shefaa Al Orman Oncology Hospital, Luxor, Egypt

Introduction: Biobanks are an opportunity for scientists alike to derive knowledge from thousands of samples. Biobanks were linked to the ambitious chance of screening and treating any disease. Human tissue samples obtained from biopsies and surgical specimens are a great resource to find potential targets to aid clinical decisions such as diagnosis and treatment of diseases. Tissue samples preserve as fresh samples in liquid nitrogen, formalin fixation, cryopreservation, lyophilization (freeze-drying), alcohol preservation, and formalin-fixed paraffin-embedded (FFPE).

In the biobank, tissue samples are collected and stored in liquid nitrogen. Therefore, the biobank provides us with various types of tissue samples to help research. The DNA extracted from tissue is important in the molecular field, so the quality of DNA must be measured. The quality of DNA extracted from FFPE usually has low DNA yields due to abundant lipid and is not always suitable for PCR. This is because of poor quality degraded template DNA as a result of extensive formalin crosslinking compared with DNA from fresh tissue. So, in this abstract we aim to compare the quality of DNA extracted from FFPE samples and fresh tissue.

Methods: The DNA was extracted from FFPE and fresh tissue by QIAamp DNA Mini Kit (Cat.No.51304) and the quality of DNA of both was assessed with spectrophotometer, then the PCR performed by thermal cycler. Finally the PCR product migrated in gel electrophoresis.

Result: After measuring the DNA concentration, we found that the concentration was perfect in two groups: the mean of concentration for FFPE was 96.12 and the mean of concentration for fresh frozen was 101.3. Then the PCR and gel electrophoresis was performed for two groups, the result of FFPE giving nonspecific band compared to the fresh tissue which give specific band.

Conclusion: Collection of fresh tissue is essential in biobanks. We found that the fresh frozen (FF) tissues exhibit superior quality compared to FFPE-derived; FFPE specimens showed lower DNA quality and nonspecific band compared to FF samples.

PA-03 The National Cancer Institute’s Biospecimen Research Database: A Longstanding, Valuable, and Robust Resource for Biobanking

K. B. Engel², S. Greytak³, P. Guan¹, H. Moore¹

¹Biorepositories and Biospecimen Research Branch, National Cancer Institute, Bethesda, Maryland, United States, ²GAP Solutions Inc., Herndon, Virginia, United States, ³Kelly Government Solutions, Rockville, Maryland, United States

Statement of Problem: Human biospecimens are a keystone of biomedical research. The conditions under which biospecimens are collected, handled, and stored can alter their molecular profiles. Differences in specimen-handling practices can translate to variability in downstream results, potentially compromising the reproducibility of clinical assays and research results. Improving reproducibility requires the harmonization of biospecimen procedures among institutions, along with the identification of optimal preanalytical practices that are fit-for-purpose. The evidence base for optimal procedures lies in the biospecimen science literature, which can be difficult to examine using conventional indexing platforms given the transdisciplinary nature of the field.

Proposed Solution: To address these needs, the National Cancer Institute (NCI)’s Biorepositories and Biospecimen Research Branch developed the Biospecimen Research Database (BRD; http://biospecimens.cancer.gov/brd), a free online web database that serves as a centralized public resource in human biospecimen science. The BRD contains (i) a curated literature repository of more than 3500 peer-reviewed articles in the field of human biospecimen science, (ii) a collaborative library of more than 800 standard operating procedures (SOPs) contributed by more than 100 organizations, and (iii) evidence-based, expert-vetted procedural guidance on biospecimen collection and handling. Curated articles and contributed SOPs that reflect the diverse scope of the biospecimen types, diagnoses, analytes, assays, and preanalytical factors captured by the BRD will be featured in the presentation. Content reflecting the interests of visitors to the website, garnered from views of curated articles and SOPs that are frequently downloaded, will also be highlighted.

Conclusions: The NCI’s BRD represents a longstanding, valuable, and robust resource in the field of biospecimen science, containing articles and SOPs that cover a variety of biospecimen types, analytes of interest, and preanalytical factors as well as evidence-based guidance tailored to support protocol harmonization efforts. We invite you to explore the BRD as a resource and to consider contributing relevant publications and SOPs addressing biospecimen handling to the database. To share your BRD experience with NCI, email us at ncibbrb@nih.gov.

PA-04 Inventory and Sorting of the Collections of the Biobank of the Institut Pasteur de Côte d’Ivoire

K. A. Kintossou¹, S. Cissé¹, M. Money¹, C. Ako², L. Coulibaly¹, F. N’Guessan¹, M. Dosso³

¹Biobank, Institut Pasteur de Côte d’Ivoire, Abidjan, Lagunes, Côte d’Ivoire, ²Computer Biology, Institut Pasteur de Côte d’Ivoire, Abidjan, Abidjan Autonomous District, Côte d’Ivoire, ³Microbiology, Institut Pasteur de Côte d’Ivoire, Abidjan, Abidjan Autonomous District, Côte d’Ivoire

Background: Biobanks are structures for managing biological samples, and for over 30 years they have been indispensable to medical research and innovation. Historically, biobanks were developed with excessive, uncontrolled collections for no specific purpose, on the assumption that they could be used for further research. Today, we realize that in many cases, these samples are not used at all, or at least not in the quantities retained, and end up being overstocked in biobanks, probably indefinitely. This phenomenon is of growing concern to biobank managers and represents one of their biggest fears. This is particularly true of the Biobank of Institut Pasteur de Côte d’Ivoire, whose storage capacity is currently reaching saturation point.

Objective: To free up storage space by sorting biological samples on the basis of their identification, associated data, and usefulness for diagnosis and research.

Methods: This work was carried out over a period of seven months (from August 2023 to March 2024) at the Biobank of Institut Pasteur de Côte d’Ivoire. It required the recruitment of six laboratory technicians and six data entry operators trained for the tasks involved.

Results: A total of 256,801 biological samples were identified in 31 storage containers. Of these, 185,965, with information on their identification, origin, and associated data, were classified and stored. This organization resulted in the availability of storage space, including seven −20 C freezers, one −30 C freezer, and three −80 C freezers.

Conclusion: This work will enable us to catalog the samples stored in the Biobank of Institut Pasteur de Côte d’Ivoire and make them available for research.

Biobanking Profiles

PB-01 Expansion of the First Biobank in Saskatchewan, Canada

S. Clairefond¹, L. Hopkins^{4, 2}, M. Milne¹, M. Kinloch^{1, 3}

¹Pathology and Lab Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada, ²Gynecologic Oncology, Saskatchewan Cancer Agency, Saskatoon, Saskatchewan, Canada, ³Gynecologic pathologist, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada, ⁴Division of Oncology & Department of Gynecology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Background: Established in October 2021, the University of Saskatchewan (USASK) Gyn Onc Biobank is the first institutional biobank in Saskatchewan, Canada. The involvement of Dr. Mary Kinloch and Dr. Laura Hopkins was instrumental in securing funding from Ovarian Cancer Canada to support the establishment of the biobank.

Methods: The biobank initially focused on collecting gynecologic oncology samples. Collection began in Saskatoon, and after six months, the same samples started to be collected in Regina. In parallel, the biobank implemented standard operating procedures and acquired the ATiM (Advanced Tissue Management Application) software and received certification from CTRNet (Canadian Tissue Repository Networks). Following an increased request for collection from surgeons, pathologists, and research teams, we adapted our consent form in the fall of 2022 for a global collection of oncology samples from all adult patients. The collection of breast and gastrointestinal samples began in the summer of 2023, while the collection of bone and soft tissue samples began in June 2024. In collaboration with a pediatric team, the biobank also set up a consent process dedicated to minor patients and in July 2024, we included the first minor patient in the biobank.

Results: Since its opening, the USask biobank has enrolled over 315 patients, storing tissue (frozen tissue, preserved live cells, FFPE block, H&E slide, DNA, and RNA), blood (plasma, buffy coat, peripheral blood mononuclear cells, serum, DNA), and ascites fluid samples. The biobank holds the aliquots’ associated data (diagnoses, treatment, and follow-up). The biobank is involved in five projects led by the USASK research teams and in two pan-Canadian projects of the Terry Fox Research Institute. The biobank has also been the focus of recruitment in the pediatric space as more clinician scientists look for access to biobanks.

Conclusions: Expanding the biobank in Saskatchewan has shown to be a significant asset for medical and biomedical research. The USASK Biobank reduces costs and administrative burdens to the researcher. The access to a biobank provides rapid access to valuable resources, promoting innovation and collaboration within the Saskatchewan scientific community.

PB-02 The Signature Biobank: A Longitudinal Biopsychosocial Repository of Psychiatric Emergency Patients

R. Juster^{1, 2}, S. Guay^{1, 2}

¹Centre de recherche de l’Institut universitaire en santé mentale de Montréal, Montreal, Quebec, Canada, ²Psychiatrie et addictologie, Université de Montréal, Montreal, Quebec, Canada

Background: The objective of the Signature Biobank is to investigate psychiatric disorders among patients experiencing crisis. To achieve this, the Signature Biobank was created with four main goals: 1) investigate the biological, psychological, and sociodemographic determinants of common psychiatric disorders; 2) assist health clinicians with improving the choice of care given to psychiatric patients by providing them with valid, reliable, and tailored biopsychosocial predictors of mental health trajectory; 3) facilitate emergency-setting research by providing practitioners with aggregated empirical data to help guide them while also encouraging patients to be involved in their treatment and care; and finally 4) promote knowledge exchange among researchers, clinicians, patients, and the broader community.

Methods: Patients who came to sick care at the emergency services of the Institut universitaire en santé mentale de Montréal (IUSMM) (Quebec, Canada) were recruited for the Signature Biobank between the years 2012 and 2020. Exclusion criteria were: do not speak French or English, not apt to provide consent after careful decisional competence evaluation by a psychiatrist, and pregnancy. Patients could opt-out for questionnaires or biospecimen sampling.

Results: The consent rate was 68%. Participants were men (60%) and aged 17-81. The Biobank has collected biological samples (n = 1,986 participants) and questionnaire data (n = 2,090). A large proportion of patients also consent to blood, saliva, and hair sampling (n = 1,926). A subsample of patients was followed-up at hospital discharge, and two additional outpatient clinic appointments (n = 958 with at least one follow-up). In addition, a socio-demographically matched comparison group of individuals who were not hospitalized for psychiatric disorders (n = 149) was also recruited. Since its initial recruitment the Biobank has participated in the publication of over 20 research publications.

Conclusion: The Signature Biobank is now one of the Canadian’s largest repositories of data collected from patients receiving care at a psychiatric emergency unit. The Signature Biobank provides real-world data for research from a clinical practice in a difficult environment of the psychiatric emergency service.

PB-03 The Quebec Cancer Research Network (RRCancer) Accelerating Oncology Research in the Province of Quebec

V. Ouellet¹, S. V. del Rincon², J. Masson³, A. Mes-Masson¹

¹Cancer Axis, Centre de recherche du Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, ²Lady Davis Institute for Medical Research, Montreal, Quebec, Canada, ³Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada

Background: The Réseau de recherche sur le cancer (RRCancer.ca), is a collaborative network, initiated over 20 years ago. The vision is to create an infrastructure of high quality biobanking to catalyze translational research in oncology in Quebec. The network is supporting more than 40 biobanks and regroups >750 members with multidisciplinary expertise. Researchers, clinicians, professionals, students/fellows, patients, and strategic partners are working toward the same goal: improving the diagnosis, prognosis, as well as care and services for cancer patients across the province.

Methods: To support high-quality biobanking aligned with international best practices, the RRCancer has been a founding member of the Canadian Tissue Repository Network that provides the research community with educational material, certification processes, policies, generic standard operation procedures (SOP), and a data management system which provides a comprehensive solution to track all biobanking activities. This infrastructure favors cohesive interoperability across institutions.

Results: The Network led the harmonization of SOPs across Quebec biobanks involved in large projects. SOPs for blood and tissue collection, processing, and generation of derivatives were harmonized for breast, ovarian, colorectal, lung, prostate, pancreas, melanoma, and hematologic cancers. RRCancer expertise is also being requested as part of pan-Canadian initiatives.

Moreover, the RRCancer led the harmonization of a general biobank information and consent form (ICF), working in concert with the ethics review boards of all university health centers affiliated with the Network. The ICF adheres to international guidelines and includes information on live biobanking, sequencing, and data deposition in large databases. During the pandemic, the RRCancer collaborated with the Centre hospitalier de l’Université de Montréal ethics review board to create remote consenting documentation to reduce interruptions in recruitment. This included phone scripts, email, and letter templates, and a comprehensive procedure. Safety measures for biobanking during the pandemic were also shared with its affiliated biobanks. A patient focus group revealed a preference for remote consent, with participants feeling more comfortable asking questions at home compared to in-hospital.

Conclusion: RRCancer’s biobanking infrastructure has enhanced agility and reduced duplication among affiliated biobanks.

PB-04 Advancing a Lipedema Research Roadmap: Planning of a Biobank to Fuel Research to Characterize the Biology of a Complex Disease

Stacey Heil^{1, 2}, Ashok Srinivasan^{1, 2}, Felicitie Daftuar¹, Guy S. Eakin¹, Stephanie Galia¹, Laura Harmacek^{1, 2}, Jonathan Kartt¹, Stephanie Peterson¹

¹Lipedema Foundation, New York, New York, United States, ²Lipedema Foundation, Greenwich, Connecticut, United States

Statement of the Problem: Lipedema is a type of adipose tissue disorder predominantly in women characterized by cuffing at the hands and feet, and pain and bruising of the limbs following an accumulation of subcutaneous adipose tissue. The lipedema field is nascent, and, despite recent advancements, approximately 50% of research papers have been published in the past five years. The Lipedema Foundation, which is a funder of research in this field, took a unique collaborative approach with a multi-stakeholder and multi-disciplinary Research Roadmap. This roadmap serves as a compilation of critical priorities that must be addressed to realize a compelling vision for the future of lipedema research that can build an environment for high-quality clinical trials and advance diagnosis and treatment. A major challenge identified in this field is the lack of centralized, well-documented biological samples that can support both current and future studies. A lipedema biobank to store and disseminate high-quality specimens and associated metadata from patients and controls is a critical unmet need.

Proposed Solution: We propose the establishment of a dedicated lipedema biobank, designed to collect, store, catalog, and distribute biological samples from a robust cohort of individuals with lipedema, as well as related conditions, and healthy controls. The biobank will facilitate the collection of diverse specimens (e.g., blood, adipose tissue, genetic material) linked to clinical data, ensuring a rich resource for researchers exploring the molecular and genetic underpinnings of lipedema. By creating a centralized, accessible platform for data and sample sharing, the biobank will enable both current and future research efforts, accelerating the discovery of biomarkers, therapeutic targets, and potential interventions, all goals from the Research Roadmap for this underserved population.

Conclusion: The ultimate goal of this initiative is to create a robust research infrastructure and biobank of accessible samples and data that accelerates scientific discovery in lipedema research, as recommended in the Research Roadmap. The biobank is designed to enhance collaboration across the research community, and support evidence-based treatment strategies for individuals with lipedema.

PB-05 Australasian Biospecimen Network Association: Harnessing the Diversification of Our Membership

G. Reaiche^{4, 2}, L. Ludlow^{5, 2}, C. Griffin^{3, 2}, A. Hettiaratchi^{1, 2}

¹University of New South Wales, Sydney, New South Wales, Australia, ²Australasian Biospecimen Network Association, Melbourne, Victoria, Australia, ³The University of Newcastle, Newcastle, New South Wales, Australia, ⁴The University of Adelaide, Adelaide, South Australia, Australia, ⁵Murdoch Children’s Research Institute, Parkville, Victoria, Australia

Statement of the Problem: Since the establishment of the Australasian Biospecimen Network Association (ABNA) in 2009 the association has grown to over 300 members, both national and international. As the membership numbers increased it became apparent that there was scope for increasing outreach and a requirement for new incentives to keep members engaged.

Proposed Solution: To capitalise on the diversification of membership several initiatives commenced in 2022, including a Seminar Series, Special Interest Groups (SIGs), and an ABNA Emerging Leadership Scholarship.

The ABNA Seminar Series is now an annual event with themes designed to showcase the breadth of the network whilst providing educational content for all members. The 2024 Seminar Series “Revolutionising Biobanking Models: Centralised, Distributed, Harmonised” consisted of three online seminars and culminated in an in-person debate at the 2024 Annual Conference, a format that has been embraced by the membership.

The ABNA SIGs was established in 2023 with four groups: the Clinical Trials & Population Cohort Biobanking SIG, the Post-Mortem Tissue Collection SIG, the Banking for Biodiversity SIG, and the Quality Management & Improvement SIG, all of which are now entering their second year of activity. This year the Indigenous Engagement in Culturally Safe Biobanking and Biospecimen Science SIG was announced at the annual meeting.

Entering its second year, the ABNA Emerging Leadership Scholarship was awarded to two recipients in 2024; this award is designed to ensure sustained engagement to emerging leaders—providing an opportunity to attend meetings or stand for committee after their initial year of membership.

Conclusions: From this sustained engagement ABNA hopes to be better placed to maintain membership and be able to continue to provide succession planning and growth in the Australasian biobanking community.

PB-06 The ISO 20387 Accreditation Practice of the Clinical Biobank of Peking Union Medical College Hospital

X. Wang, H. Zhu, T. Xie, Y. Zhang, D. Guo

Peking Union Medical College Hospital, Beijing, Beijing, China

Background: The Clinical Biobank of Peking Union Medical College Hospital (PUMCH) was established in 2012, a standardized hospital-level specimen biobank built according to international standards and national regulations. The Biobank received accreditation to ISO 20387 international standard since 2022 as the sixth accredited biobank in China.

Methods: The Clinical Biobank set up a quality management system following ISO 20387. This system covers all aspects, including personnel competence, dedicated facilities and environment, external supplies, equipment management, sample collection, preparation, storage, and quality management for standardized operations. Since 2021, the sixth-edition system documents have been in use. A total of 267 internal documents at four levels have been established. The Biobank conducts internal and external quality management activities annually. Internal quality management covers sample types like body fluids, tissues, cells, and nucleic acids. Random checks on project and sample information are done to ensure project compliance and sample information accuracy. External quality management includes PT, external quality assessment, and third-party quality control. The Biobank regularly conducts personnel, instrument, method comparisons, verification, and validation tests on new methods. Internal audits and management reviews are carried out annually for the whole of the biobanking activities. By combining self-inspections and external audits, the Biobank improves its quality management system. Based on this quality management system, the Biobank has established an integrated platform for technical services, scientific research cooperation, teaching, and training. This platform turns each sample into high-quality specimens and data, providing full-process, standardized, intelligent, all-around, and traceable sample and information management for clinical and translational medicine research projects.

Results and Conclusions: Standardization is the basis for high-quality scientific and technological development for the Clinical Biobank of PUMCH. Conducting international cooperation and exchanges via accreditation and striving to create a “Chinese model” in standardized construction and translational application drives the sustainable development of the biobanking industry.

PB-07 Establishment of a Biorepository of Philippine Bat Virome and Therapeutics for Clinical and Research-Based Applications (PhilBioBaT)

M. P. De Leon¹, N. G. Sabino², L. B. Sibal¹

¹Microbial Culture Collection, Museum of Natural History, University of the Philippines Los Baños, Los Baños, Laguna, Philippines, ²Microbiology Division, Institute of Biological Sciences, University of the Philippines Los Baños, Los Baños, Laguna, Philippines

Statement of the Problem: The COVID-19 pandemic took the world by surprise, resulting in millions of deaths due to its high transmissibility and virulence. The pandemic’s effects were disproportionately severe in third-world countries, such as the Philippines, which lacked the technological resources and facilities necessary to actively participate in the global effort to contain the SARS-CoV-2 virus through vaccine research. Consequently, these nations depended heavily on data and prophylactic measures generated by developed countries, highlighting the need for local capacity building in pandemic preparedness.

Proposed Solution: To address this gap, the project “Establishment of a Biorepository of Philippine Bat Virome and Therapeutics for Clinical and Research-Based Applications under the VIP (PhilBioBaT)” was conceptualized. The PhilBioBaT project functions as a biological resource center (BRC) for bat-borne specimens and metadata, aiding its mother program called the PREVENT Program (Pandemic Response Preparedness for Emerging Bat-Borne Viruses), together with its three other sister projects. This initiative aims to enhance the country’s readiness to combat bat-borne viruses with pandemic potential.

The project funded by the Philippine Department of Science and Technology (DOST) seeks to establish a biobank for the preservation of specimens and metadata from bat species in Quezon Province, Miagao, and Sultan Kudarat, Philippines (nexus of bat-human interfaces). The biobank will ensure the integrity and quality of biospecimens for clinical and research applications, eventually transitioning to the Virology and Vaccine Institute of the Philippines. Additionally, the PhilBioBaT initiative emphasizes training personnel in biobanking, biosafety, and biorisk management to ensure compliance with international standards.

Conclusions: The establishment of PhilBioBaT will bolster the Philippines’ capacity to respond to pandemics as BRCs aid immediate emergency response that relies on diagnostics, surveillance, testing, and treatment proposals. The project will also enhance the country’s research capabilities through the Virology and Vaccine Institute of the Philippines, ensuring preparedness for future outbreaks. This initiative represents a significant step towards self-reliance in public health and virology research.

Biobanking Structures & Cross-Sector/Species Partnerships

PC-01 Westmead Biobank Facility Advancing Precision Medicine through the PrecisionGO Project

Y. Wang¹, P. Harrison¹, J. Carpenter^{1, 2}, C. Clarke^{1, 2}, X. Wang^{1, 2}

¹Westmead Institute for Medical Research, Westmead, New South Wales, Australia, ²The University of Sydney, Sydney, New South Wales, Australia

Statement of the Problem: Despite Australia’s growing medical research capabilities, there remain significant gaps in infrastructure and research capacities that hinder the development of a comprehensive precision medicine framework. These deficiencies slow down biomarker discovery, the creation of personalized treatments, and improvements in patient outcomes. PrecisionGOTM is a transformative initiative funded by the Medical Research Future Fund (MRFF) under the National Critical Research Infrastructure program.

Proposed Solution: Anchored at the Westmead Institute for Medical Research within the Westmead Research Hub, PrecisionGOTM aims to bridge these gaps by integrating cutting-edge technologies to create comprehensive precision medicine pipelines, sophisticated data analytics, and educational initiatives aimed at accelerating biomarker discovery, developing personalised treatments, and improving patient outcomes. This initiative capitalises on the resources of the WRH Core Facilities (WRHCore), which supports over 690 research projects involving 260 clinical and research groups across 46 organizations. WRHCore provides key scientific platforms including biobanking, genomics, flow cytometry, imaging, histology, and bioinformatics, all crucial to advancing precision medicine. This collaborative and resource-rich environment enables multidisciplinary teams to advance research and innovation in personalised healthcare.

Established in 2018, the Westmead Biobank (WB) has been a vital component of this ecosystem, offering standardised sample collection, processing, storage, and distribution, alongside effective data management through the laboratory information management system Matrix Gemini. WB has supported over 60 projects from 50 groups from nine organisations. Its unified governance structure ensures rigorous quality control and consistency in biobanking practices, which are critical for high-impact research.

Conclusions: As a critical component of the PrecisionGOTM pipelines, WB will enable breakthroughs in precision medicine by providing an integrated platform that combines biological samples with essential clinical information. These efforts will significantly enhance Australia’s precision medicine landscape, maximising the benefits of biobanking and improving precision medicine for patients nationwide.

PC-02 Bridging Theory and Practice: Lessons from Establishing Pakistan’s First Pediatric Acute Leukemia Biobank

J. Aijaz¹, F. Naseer³, N. Jawaid², N. Bhakta⁴, T. Alexender⁵, M. C. Roberts⁶

¹Molecular Pathology, Biorepository, Indus Hospital & Health Network, Karachi, Pakistan, ²Biorepository, Indus Hospital & Health Network, Karachi, Sindh, Pakistan, ³Molecular Pathology, Indus Hospital & Health Network, Karachi, Sindh, Pakistan, ⁴Global Pediatric Medicine, St. Jude Children’s Research Hospital, Memphis, Tennessee, United States, ⁵Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina, United States, ⁶Division of Implementation Science in Precision Health and Society, University of North Carolina, Chapel Hill, North Carolina, United States

Background: Biobanks are increasingly recognized as a fundamental resource for research but pose unique implementation considerations. Most implementation science literature, however, focuses on clinical interventions. Applying well-documented implementation theories and strategies to biobanking will enhance cross-situation comparisons and promote effective utilization. This is crucial for environments where both biobanking and implementation science are in their inception stages. The study has thus employed the most widely recognized implementation science frameworks (EPIS and ERIC) to plan and report pediatric acute leukemia sample banking at Indus Hospital & Health Network (IHHN), Karachi. IHHN is a network of country-wide, non-profit, free of charge, health care facilities in Pakistan—a low-middle income country.

Methods: Implementation planning workgroups included clinicians, electronic medical records department, information technology department, clinical management, senior leadership, and institutional review board. External planning support was provided by St. Jude Children’s Cancer Hospital and University of North Carolina, USA. ERIC (Expert Recommendations for Implementing Change) strategy selection through stakeholder workgroups considered scope, budget, feasibility, and context in addition to standard protocols from ISBER and BCNet. The EPIS framework (Exploration, Preparation, Implementation, Sustainment) was used to map and organize the selected ERIC intervention strategies.

Results: Biobank implementation, organized by EPIS stages, employed 41 strategies. Of these, 34 were selected from the originally published ERIC strategies (73 in total). Seven were added through workgroup consensus; 599 acute leukemia and 1137 solid tumor specimens have been banked since inception of the biobank operations two years earlier. The implementation activities and challenges to be described include infrastructure, swift specimen collection, and informed consent. The ancillary processes including training and quality control will also be described and related data presented.

Conclusion: The implementation of Pakistan’s first acute leukemia biobank using ERIC and EPIS frameworks offers a structured approach beneficial for settings with limited biobanking experience. This intervention aligns with recognized implementation science frameworks, while addressing aspects pertinent in low- and middle-income countries.

PC-03 Significance of Biobank Registry in Facilitating Biobanking Process and Enhancing its Quality

M. Saady, R. Mohamed, A. M. Gamal, A. Ramadan, S. Aboelela, A. Saleh

Shefaa Al Orman Oncology Hospital, Luxor, Egypt

Background: Health information systems in health care institutions are based on detailed individual level information. All register-based sources include a personal identification number for patients, which can be used for data linkages. Research in cancerous diseases is typically fragmented by data type and disease. Individual efforts often do not systematically connect data across clinical phenotype, genomic data, biomaterial availability, and research/trial data sets. In addition, the main problems in using biobank material are limited availability of blood derivatives, the risk of decreased sample quality, the ideal selection of study plans, and the complex process to get permission to use the data and to form it. The use of register data is limited to existing data with good quality, so the archiving and sharing of completed biobank analyses are recommended. Biobank register aims to gather enough information about enrolled samples to be able to physically trace them.

Methods: In Shefaa Al Orman Hospital, we have registered the medical data of the enrolled patients in biobank. In accordance with biobanking criteria that was implemented, cancer-diagnosed patients without any treatment were accepted. By biobank coding system, patients’ specimens are stored; their demographic and medical data, including cancer type, morphological diagnosis, topography site and sub-site, grade, stage of cancer, clinical features, and comorbidities, are all registered in biobank registry to facilitate the collection of such data for any participant in any study and to ensure the correct diagnosis as a biobank sample.

Results: After working hard on enrolled biobank samples and inventory of medical information for their correct diagnosis, we came up with the following. It was found that about 10,080 total biobank samples until Sep 2024 are registered in detail with the medical condition and clinical data. About 1987 samples are diagnosed breast cancer, 775 liver cancer, 697 colorectal, 604 lung, 565 bladder, 535 lymph nodes, 457 thyroid, 355 pancreatic, 322 prostate, 214 ovarian; 545 non-cancer samples are used as controls, And the remaining samples are distributed among other cancer types.

Conclusion: Our efforts that have been invested in collecting and recording patients’ diagnostic data contributed to enhancing the quality of the biobank samples and their information for significant results for future studies.

PC-04 Sustainability Strategies at the MRC/UVRI and LSHTM Biobank; A Pathway to Long Term Viability

E. Nabanoba

MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Wakiso, Uganda

Statement of the Problem: Biobanks are a vital resource in advancing biomedical research through collection,storing and distribution of biological samples. However,as the demand for the collections continues to grow,biobanks are faced with financial constraints,environmental impacts and social concerns.These create the need for biobanks to adopt sustainable practices to ensure long term viability and hence continued support to scientific discoveries and innovations.The MRC/UVRI biobank has a growing collection of samples, to ensure that there is long term viability of this resource, a number of sustainability strategies are being implemented.

Proposed Solutions: The MRC/UVRI and LSHTM Uganda Biobank, through its sustainability plan, is currently undertaking activities to ensure operational, financial, environmental, and social sustainability.

Financial and operational strategies include a cost recovery model that was initiated in 2020 and a user fee attached to biobank services such as storage and retrievals. A well-written not-for-profit organisation business plan outlined strategies for optimizing resource utilization:

1)

Investment in infrastructure and technology through procuring energy-efficient machines, use of solar energy, and secure data management systems.

2)

Standard operating procedures to ensure consistence in all its operations.

3)

Quality management systems, including regular audits, to ensure compliance to national and international standards.

4)

A well-established risk management committee that meets regularly.

Environmental strategies include: 1)

Procuring energy-efficient freezers.

2)

Decommissioning of old equipment.

3)

Use of LED lights.

4)

Digitalization of paper-based procedures.

Social strategies include: 1)

A well-established community advisory board with annual meetings to address community concerns as well as providing updates to the community.

2)

Regular review reports from the compliance and regulatory office to ensure that all requirements are being met.

3)

International networks to increase visibility and opportunities for collaborations.

Conclusion: The sustainability of biobanks is crucial and requires an integrated approach of all pillars of sustainability through adoption of a cost recovery model, a clear business plan, standard operating procedures, and a good quality management system. Use of energy efficient freezers, waste management initiatives, and social strategies such as community engagement have seen the biobank take a step in ensuring sustainability.

PC-05 Understanding Biobank Participation: Demographic Insights into Biobank Consent Decisions and Refusals

P. Seenauth, L. Weiss, N. Recio, H. Wagner, N. Fleshner

Surgical Oncology, University Health Network, Toronto, Ontario, Canada

Background and Rationale: Biobanks have served as invaluable resources for advancing research in conditions affecting the urinary systems. By facilitating large-scale, longitudinal studies, the McCain GU Biobank has led researchers to an improved comprehension of disease etiology, progression, and treatment response, setting in motion a foundation for advancing diagnostics, therapeutic interventions, and precision medicine. Based in the multi-cultural downtown core of Toronto, understanding the ethnicities and demographics of patients who readily participate in the biobank is essential in providing continued support to biobanks as repositories, integral of development of a well-curated representative collection for research as well as underscoring the behavioral shift in patients in regard to research participation.

Objective: This investigation aims to quantitatively assess consent rates obtained over the years, with a focus on identifying trends among those who have consented. To further analyze this objective, refusal rates were compiled and compared with the consent rates.

Methods: Data on consent rates were collected and demographics were obtained from questionnaires collected at the point of consent. Refusal rates, without demographics, were also documented. Comparative statistical analyses as well as patient feedback evaluations were employed to understand the deviations in consenting and refusal patterns.

Conclusion: Our findings provide insights into demographic factors attributed to biobank participation. These data can tailor a new recruitment strategy to enhance biobank enrollment in underrepresented communities, leading to a more inclusive future in biobanking.

PC-07 Efficiently Reducing the Carbon Footprint of a Large Biorepository

E. Shepherd, J. Cannon, K. Langenbach

Precision for Medicine, Precision Medicine Group LLC, Bethesda, Maryland, United States

Statement of Problem: What level of energy savings (kWh per day) can be realized through implementation of energy-saving practices in a large biorepository setting?

Proposed Solution: Reducing energy consumption, by improving storage efficiency, performing routine/preventative maintenance, and retiring equipment is a focus of our organization. In this scenario we explored the energy savings gained from one of the biorepositories we manage, on behalf of the National Institutes of Health (NIH). The National Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen Repository (Biorepository) holds > 4 million specimens collected from > 62 completed NHLBI clinical studies and trials, allowing continued biospecimen access to qualified investigators for secondary analysis. The specimens are stored in 138 freezers (at ≈ −80 C), two units at −20 C, one unit at 4 C, and in eight liquid nitrogen (LN) units (at ≈ −196 C).

Historically, the majority of the biospecimens housed in the Biorepository had been received as bulk transfers at the end of a clinical study and freezer boxes had not been consolidated prior to transfer. Additionally, non-consecutive unoccupied spaces occur as vials are requested/distributed. The result was that ≈30% of available freezer space was not being utilized effectively. In 2016 we engaged in an effort to consolidate units. Beyond routine consolidation the team performs tasks aimed at reduction of energy consumption.

To quantify the energy savings gained by these activities from August 2023 to May 2024 we leveraged the “My Green Lab Freezer Challenge” sponsored by My Green Lab®. During the Challenge period the team created new sample inventories, or updated existing inventories, for 15 units and cleaned out, or removed samples from, 78 freezers and three LN units. We discarded 57,597 samples leading to the retirement, without replacement, of 10 freezers.

Additionally, we focused on energy efficiencies gained from freezer repair and preventative maintenance including removing dust/debris from the 141 storage units. Additionally, we cleared the door gaskets, hinges, sub-lids, and seals of frost or ice buildup. Preventative maintenance was also performed on the eight LN units, including ensuring there was no leakage and the units were operating optimally.

Conclusion: Taken together, these efforts resulted in an estimated savings of 496.35 kWh per day and are part of a larger corporate initiative to reduce our carbon footprint and our greenhouse gas emissions.

PC-08 Overcoming Challenges in Building a Rare Cancer Biobank: Strategies for Definition and Collaboration

A. Mejia Benitez, N. Rastegar, M. BeGora, N. Fleshner, H. Wagner

Biospecimen Services, University Health Network, Toronto, Ontario, Canada

Background: Rare cancer definitions vary internationally, with thresholds ranging from fewer than 2-6 cancer cases per 100,000 in Europe and Canada to fewer than 15 cancer cases in the United States. Rare cancers represent a substantial cause of morbidity and mortality. However, limited research, inadequate models, and fragmented data sharing hamper progress in understanding and treating these diseases. Establishing a rare cancer biobank could significantly accelerate research and clinical breakthroughs by improving collaboration, enhancing data accessibility, and addressing common barriers across rare cancer types.

Objective: The goal of this initiative is to develop standardized definitions across University Health Network (UHN), improving data sharing and creating a robust infrastructure to collect and manage these biospecimens.

Methods: A retrospective cohort analysis with full-text and synaptic searches was made to identify potential cases of rare cancers. This process also involves screening patient records for consent status and collecting relevant clinical and pathological data.

Results: We’ve chosen to organize the collection by tissue site to enhance coordination with pathologists and clinicians. This strategy streamlines collaboration and enables us to refine our list of rare cancers based on their collective expertise. So far, we have gathered 300 biospecimens from gastrointestinal cancers and are currently selecting cases from genitourinary cohorts. However, we’ve encountered some internal challenges, including discrepancies in rare cancer definitions across healthcare providers, variations in terminology, and difficulties in securing full engagement from clinical teams and pathologists to ensure accurate data collection.

Conclusions: A concerted effort to define rare cancer types and standardize data collection practices is essential for creating a successful biobank. Strengthening collaboration across healthcare providers, and clinical teams is crucial for overcoming existing barriers, such as terminology inconsistencies and the complexity of consent processes. The establishment of a rare cancer biobank will improve accessibility to research materials, facilitate data sharing, and expedite the discovery of novel treatments for these high-mortality cancers. Future initiatives should focus on developing unified protocols, enhancing training for healthcare professionals, and fostering collaboration.

PC-09 Driving Increased Training Engagement, Flexibility, and Resource Improvement through Utilization of a Peer Training Structure in the Biobank

A. Thangeswaran, N. Harvey, S. Ding, N. Rastegar

University Health Network, Toronto, Ontario, Canada

Background: Biobanks rely on a team with diverse skills and expertise across several fields. The complex and multidisciplinary nature of biobanking poses ongoing challenges with respect to hiring, training, and staff retention. At their foundation, biobanks rely on highly trained lab technicians, adept in sample handling, storage, and quality control protocols. However, factors such as demanding work, limited funding and growth opportunities, and a competitive job market lead to high turnover in lab staff, driving the need for continuous training. While the training of new biobank staff can be repetitive, UHN Biospecimen Services (UHN BSP) has implemented a peer-training model that allows for increased staff engagement and continual improvement of training resources.

Methods: Since 2018, UHN BSP has hired and trained undergraduate co-operative/professional work term (co-op) students with overlapping work terms, developing a peer-training model with junior and senior technicians. This structure has helped UHN BSP combat common training challenges such as inflexible instruction and outdated guidance documents, while also providing leadership experience to senior co-ops. By avoiding overreliance on online training modules and rigid training structures, learning responsibilities become more accessible and engaging. Furthermore, the peer-to-peer training model fosters open communication and allows new staff to seek guidance comfortably from their peers in the fast-paced and demanding work setting.

Trained biobank staff can also utilize their training experience to identify and update gaps in guidance documents or standard operating procedures. To accommodate protocol updates, new studies, or any staff-recommended troubleshooting, guidance documents are regularly established and updated. This reduces the risk of repeat errors and enhances training efficiency and thus improves biospecimen handling and storage quality. Creating and modifying training materials to improve knowledge transfer to new staff leads to a wealth of reliably tested resources and enhanced training outcomes.

The peer-to-peer training model at UHN BSP allows for flexible and engaging training and encourages the continuous improvement of biobank instructional resources. Empowering senior students as active participants in the training process fosters a cooperative, dynamic environment for biospecimen banking, strengthening staff investment and commitment to the continuous growth of the organization.

PC-10 Breaking the Specimen Black Box Cycle

K. Wyatt¹, A. Black², M. Henderson²

¹Cancer Genomics Research Lab, Leidos Biomedical Research Inc., Rockville, Maryland, United States, ²Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, United States

Statement of the Problem: NCI’s Division of Cancer Epidemiology and Genetics (DCEG) has accumulated millions of specimens from its numerous studies over the years. As investigators retired or moved on to other institutions, the specimens remained with DCEG, and the custodianship was passed onto other investigators who may or may not have been aware of their responsibility. Our Biological Resources team is reviewing each study collection with the custodians. Custodians are being asked about their knowledge of the specimens associated with each study, where the accompanying documentation and data are located. A cycle of passing down studies with incomplete knowledge existed, and needs to be interrupted, shedding light into a current black box.

Proposed Solution: A review and overhaul of the offboarding process was conducted by DCEG’s Office of the Director. Procedures addressing the appropriate custodial transfer of specimens were identified and added to the offboarding process. The necessary steps for a quality transfer of custodianship of the collection and data will be discussed. Involvement of the outgoing custodian and the new custodian is crucial to the process and to align with data sharing policies.

Conclusion: Many repositories have “those specimens” where no one seems to know what study they were collected for, nor where any of the associated documentation/data resides. When procedures are in place, the transition of specimen custodianship from one investigator to another should help eliminate confusion after an investigator has left the institution. This presentation will discuss how DCEG recognized the problem, and the procedures added to the offboarding process to ensure all information is transferred along with the custodianship of specimens. DCEG’s experience with knowledge management during custodial transfer is not unique. Other biobankers will benefit from the details of our new off boarding procedures to support their own operational processes.

PC-11 Facilitating Research Access and Biobank Sustainability: Creation of a Collaborative Network of Independent Oncology Biobanks

K. Maksimovic¹, R. Cox¹, L. Phouthavongsy¹, I. Lungu¹, D. Chadwick^{1, 2}, L. Stein^{1, 2}, A. Oduwole³, A. Zaidi⁴, A. Bondoc⁵, C. Shire⁶, C. McKenna⁷, C. Giuffrida⁸, D. Torti⁹, D. Stuart⁷, E. Zaffino⁹, E. McKay⁹, G. Wood⁷, G. Celebre⁴, H. Wagner¹⁰, H. Dimaras¹¹, J. Petzke⁶, K. Flegg¹¹, K. Godard¹², K. McDonald¹³, M. Oblak⁷, M. Sabloff¹², N. Rastegar¹⁰, S. Hafezi Bakhtiari¹⁴, S. Virk¹⁵, S. Kellett⁸, S. Chowdhary¹⁶, T. Bryce¹⁷, T. Khazaee¹⁸, V. Di Giovanni¹⁹, W. Matar²⁰

¹Ontario Institute for Cancer Research, Toronto, Ontario, Canada, ²University of Toronto, Toronto, Ontario, Canada, ³Biospecimen Repository and Processing Lab, Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada, ⁴Ontario Tumour Bank, St. Joseph’s Healthcare Hamilton, (Hamilton, Canada), ⁵Brain Tumour Research Centre, Hospital for Sick Children, Toronto, Ontario, Canada, ⁶Ontario Tumour Bank, London Health Sciences Centre, (London, Canada), ⁷Ontario Veterinary College Veterinary Biobank, University of Guelph, (Guelph, Canada), ⁸Brain Tissue Biobank, Unity Health Toronto, Toronto, Ontario, Canada, ⁹Central Biobank, Hospital for Sick Children, Toronto, Ontario, Canada, ¹⁰UHN Biospecimen Services, University Health Network, (Toronto, Canada), ¹¹Department of Ophthalmology and Vision Sciences Biobank, Hospital for Sick Children, Toronto, Ontario, Canada, ¹²The Ottawa Hospital Hematology Biobank, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada, ¹³Ontario Health Study, Ontario Institute for Cancer Research, Toronto, Ontario, Canada, ¹⁴Lakeridge Health Biobank, Lakeridge Health, (Oshawa, Canada), ¹⁵Tumour Tissue Data Repository, Canadian Cancer Trials Group, (Kingston, Canada), ¹⁶McCain GU Biobank, University Health Network, Toronto, Ontario, Canada, ¹⁷Clinical Research Laboratory & Biobank-Genetic & Molecular Epidemiology Laboratory, Hamilton Health Sciences, (Hamilton, Canada), ¹⁸Sunnybrook Biobank, Sunnybrook Research Institute, Toronto, Ontario, Canada, ¹⁹Unity Health Biobank, Unity Health Toronto, Toronto, Ontario, Canada, ²⁰Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada

Statement of Problem: Ontario is home to over 20 independent oncology biobanks. Researchers who need access to large numbers of samples, especially from rare cancers, can be hampered by having to deal with multiple biobanks, each with unique sample access procedures, fee schedules and contracts. To enhance access to samples, data, and services and to facilitate collaboration, the Ontario Tumour Bank, supported by the Ontario Institute for Cancer Research, is leading the formation of a provincial biobank network. Members include diverse biobanks specializing in solid cancers and hematologic malignancies from adult, pediatric and companion animal participants, and from population and cancer clinical trials biobanks. Current challenges are creating a federated catalogue of inventories and harmonizing the research request process across member biobanks.

Proposed Solution: Progress includes approval of a network charter and terms of reference for working groups. The working groups have been assigned responsibilities based on members’ specializations. The Governance group is responsible for ensuring network progress including member engagement. The Internal Processes group is reviewing informed consent forms to better triage requests, as well as Material/Data Transfer Agreements to work towards harmonization. The Public Facing group is developing a federated catalogue of samples, data and service offerings. This involves compiling retrospective inventories of samples and data from member biobanks, as well as research services such as sample processing, digital slide scanning, cryogenic storage, and capacity for custom prospective collections. The Funding group is developing a common application and harmonized fee schedule by comparing forms and access fees charged by member biobanks to research clients. Annual workshops are being organized where members will approve the harmonized research request process to start sharing requests from academic and industry clients.

Conclusions: With strong involvement from member biobanks, development of the provincial network of oncology biobanks has progressed significantly since its inception. Future work includes launch of a website to access the federated catalogue. Networking across biobanks has the potential to increase collaboration, accelerate research through streamlined access to samples, data and services, and increase visibility to clients, ultimately enhancing cancer research and care in Ontario and beyond.

PC-12 Evolving Biobank Database Architecture: Supporting Growth and Adaptation Over 20 Years of Operation

L. Phouthavongsy¹, K. Maksimovic¹, R. Cox¹, D. Chadwick^{1, 2}, L. Stein^{1, 2}

¹Ontario Institute for Cancer Research, Toronto, Ontario, Canada, ²University of Toronto, Toronto, Ontario, Canada

Statement of the Problem: For two decades, data capture at Ontario Tumour Bank (OTB) has progressed to support more complex research studies. Hosted at the Ontario Institute for Cancer Research, the existing database has evolved to store more diverse data, support sample accrual from new partner hospitals, and data migration to a scalable commercial platform. A key challenge was ensuring that the migration process preserved the integrity and accessibility of existing data, while also accommodating new data fields. At inception, OTB relied on Excel worksheets for sample tracking. As the data grew and Excel became increasingly unmanageable, OTB migrated to its first biobank information management system (BIMS), which laid the foundation for data collection over the next decade. OTB recently completed another migration, and as part of this process, there was a need to ensure smooth integration with reporting software to support key performance indicator (KPI) reporting.

Proposed Solution: Currently, OTB utilizes a centralized database with four hospitals that recruit participants and collect specimens and clinical data. With an integrated framework between internal and external software, OTB recently executed a data migration to an updated, scalable central database capable of accommodating both existing and new data types. To achieve this, it was essential that our database included a comprehensive data dictionary, which was crucial to ensure that data could be accurately mapped and transferred to the new system without loss of information or compatibility issues. With this in place, KPI reports were migrated as to continue current reporting processes.

Conclusions: The migration to a new biobank database, underpinned by a robust data dictionary and dynamic data framework, has enhanced OTB’s ability to capture new data types such as custom prospective blood and tissue collections. In addition, this system is well positioned to support the onboarding of new partner hospital sites. The data dictionary remains an essential tool for maintaining data consistency and guiding the incorporation of new data fields as research needs evolve. An important outcome of this migration was the ability to maintain accurate, real-time KPI reporting using new software. Looking ahead, we plan to continue evolving our database architecture by integrating machine-learning tools and genomic data to support the biobank’s growth and development and better meet the evolving needs of researchers.

PC-13 Infectious Disease Biobanking in Low-Middle Income Countries

I. Cheong, J. Luong

Shanghai Jiao Tong University School of Public Health, Shanghai, Shanghai, China

Background: Biobanking facilities are well established in high-income settings with significant funding for infrastructure. In contrast, biobanks in low- and middle-income countries (LMICs) face ongoing challenges due to a high burden of infectious diseases. Their establishment often stems from targeted projects addressing health issues, such as human immunodeficiency virus, tuberculosis, Zika, Ebola, and recently COVID-19. This has resulted in dedicated biobanks aimed at monitoring and controlling these infections.

Key challenges for biobanks in LMICs include inadequate equipment, lack of laboratory information management systems (LIMS), insufficient dedicated facilities, a shortage of skilled personnel, and the need for robust governance frameworks. Addressing these challenges is crucial for developing successful biobanks that can impact public health.

Methods: To navigate these obstacles, several actions can be implemented. Manufacturers are forming partnerships to invest in low-cost innovations, such as COVID-19 diagnostics, enabling biobanks to collaborate on evaluating these products in resource-limited settings. LIMS should enable standardized data collection per international guidelines like Minimum Information About Biobank Sharing (MIABIS 2.0), ensuring data quality and comparability across collections. This is essential for sharing within institutions and engaging in international research initiatives. Continued exploration of Open Access Software can also provide vital support for biobanking initiatives focused on infectious diseases.

Conclusion: While there is notable engagement in infectious disease research among LMIC biobanks, their numbers remain insufficient to meet population and clinical needs. Our experience highlights five primary challenges: equipment, LIMS, dedicated facilities, skilled personnel, and governance. Addressing these issues, along with leveraging existing infrastructure, may enhance the value of biobanks and lead to increased resource allocation and public support. Collaboration with established systems will bolster their contributions to clinical research and enhance health outcomes in LMICs.

PC-14 Biobanking Regulatory Framework in Southeast Asia

I. Cheong

Shanghai Jiao Tong University School of Public Health, Shanghai, Shanghai, China

Background: Southeast Asian countries face major public health challenges due to population growth, urbanization, environmental pollution, and the (re)emergence of infectious diseases. To address these challenges, the capacity for research that meets local and regional needs is crucial. In this context, biobanking—standardized collection of biological samples and data—has evolved over recent decades to support biomedical and clinical research and surveillance. However, the regulatory landscape surrounding biobanking in ASEAN member states is not well understood or reported, which this narrative review aims to explore.

Each ASEAN nation has unique regulatory arrangements that may be adequate for current operations but unlikely to support the regional sharing of biological samples and data. Many countries have overlapping regulatory frameworks, indicating a need for consolidation under a unified structure. This field warrants further investigation and the development of practical proposals to harmonize biobanking and facilitate the exchange of samples and data regionally and beyond.

Methods: The narrative review focuses on the legal frameworks governing biobanking, offering a comprehensive overview rather than using systematic review methodologies. A query regarding existing national regulatory frameworks was posed to ASEAN biobanking and biosafety experts during the Biobank Feasibility Study Project, reflecting their national expertise.

Established biobanks demonstrate compliance with national and international standards for tissue and data handling, integrating effectively into local research and maintaining governance frameworks. Countries like Singapore have robust legal instruments that clearly define biobanking operations, which are regularly reviewed. In contrast, countries like the Philippines have created guidelines in response to immediate needs but require a more coordinated approach for future development.

Conclusion: While some nations, such as Cambodia, Myanmar, and Malaysia, have legal frameworks that are currently sufficient, the scientific community agrees that a specific set of guidelines will be necessary to address unique biobanking challenges. Overall, while current arrangements in ASEAN member states may address present needs, they are inadequate for supporting the regional sharing of biological samples and data benefits, necessitating future consolidation under a unified framework.

PC-15 Survive, Drive, and Thrive – Business Model for Collaborative Research

L. Wallace, A. Henders

Institute for Molecular Bioscience, The University of Queensland, Brisbane, Queensland, Australia

Statement of the Problem: The Human Studies Unit (HSU) has needed to develop strategies to enable and support financial self-sustainability. Managing the on-going costs associated with our biorepository against limited opportunities to generate income has seen the HSU employ multi-pronged business strategies to progress financial independence and deliver successful research outcomes.

The HSU provides dedicated and centralised human research support specifically in the areas of genetics and genomics. It supports national and international research and commercial research programs across a broad range of areas ensuring regulatory and legal compliance. Establishing centralised research infrastructure underpinned by our HSU Content Management System, developed and built in-house, enables research projects to undertake genetic and genomics strategies within their programs, avoiding the requirement for independent large investments in their own laboratories.

Proposed Solution: Working closely with research governance experts and financial advisors, the HSU has adapted its operational model from a research laboratory to a collaborative research and infrastructure provider. This blended model facilitates basic research but enables independent research and development in methods and technologies (in emerging research themes) to attract contract research whilst providing on-going professional development for staff and opportunities for post-graduate students.

Financial viability and on-going sustainability are paramount to its continued success and have necessitated the management of multiple income streams from national and foreign sources. Key changes were implemented in 2024 and new ventures undertaken to support the growth of the HSU and accumulate profits that could be used to support operational and investment cost into the future.

Conclusions: Key changes implemented in the last financial year have seen the HSU generate a profit that will support operational and R&D activities. These will underpin the sustainability of the unit, facilitate diversifying our capabilities, and enable our research infrastructure and expertise to remain current and in line with emerging technologies.

PC-16 ZIMS—A Biobank Data Management Tool with Global Implications for Species Conservation

R. Thompson², P. Mackie¹, G. F. Mastromonaco¹

¹Reproductive Sciences, Toronto Zoo, Toronto, Ontario, Canada, ²Species360, Minneapolis, Minnesota, United States

Background: Conservation efforts for threatened and endangered species rely heavily on accurate and accessible data to inform action plans. However, existing biobank data for these species are fragmented, lack standardization, and are not effectively integrated with essential conservation tools. This disconnection poses significant challenges for researchers, conservationists, and policymakers seeking to implement timely and evidence-based strategies for species preservation.

Methods: To address this critical issue, a collaborative partnership has been established with Toronto Zoo and Species360 to develop an innovative biobanking software solution. The Zoological Information Management System (ZIMS) platform aims to globalize biobank data by standardizing collection methods, enabling secure data sharing, and providing advanced data analytics capabilities. Additionally, the solution provides integration opportunities with the International Union for Conservation of Nature Red List categories, facilitating alignment with global conservation priorities. A key growth opportunity includes incorporation of PMx gamete resource bank to support population management and genetic diversity assessments.

Conclusion: A viable product has been successfully developed, providing a robust foundation for addressing the disconnection in biobank data management. Looking forward, we seek to expand the ZIMS functionality and encourage its adoption among global conservation stakeholders. By doing so, this initiative aims to further support the development and execution of effective conservation action plans, fostering collaboration and innovation in the fight to preserve global biodiversity. It also highlights the importance of cross-industrial partnerships and leveraging unique expertise to create global conservation-focused technologies.

Biodiversity/Environmental/Animal Repositories

PD-02 The Ontario Veterinary College Veterinary Biobank: Facilitating Translational Cancer Research

D. Stuart¹, C. J. McKenna¹, B. Coomber², P. Woods³, M. Oblak¹, G. Wood⁴

¹Clinical Studies, University of Guelph Ontario Veterinary College, Guelph, Ontario, Canada, ²Biomedical Sciences, Professor Emerita, University of Guelph Ontario Veterinary College, Guelph, Ontario, Canada, ³Clinical Studies, Professor Emeritus, University of Guelph Ontario Veterinary College, Guelph, Ontario, Canada, ⁴Pathobiology, University of Guelph Ontario Veterinary College, Guelph, Ontario, Canada

The Problem: Research in veterinary medicine is often limited to prospective clinical trials due to a scarcity of available retrospective samples. There is a notable lack of veterinary biobanks in Canada, leaving a significant gap in veterinary and translational research on both an academic and industry level.

Proposed Solution: The formation of standardized veterinary biobanks in Canada will facilitate access to research samples; many academic referral institutions have sufficient caseloads and resources for this purpose. To ensure best standard practices, registration, certification, and training through the Canadian Tissue Repository Network (CTRNet) and International Society for Biological and Environmental Repositories (ISBER) are essential to maintain consistency and quality across all biobanks. Standardized client consent practices; data collection, including diagnostic reports and treatment outcomes; and collection of biological samples within pre-determined times and processing into derivative samples as resources allow further strengthened research potential. Storage of outcome and treatment data in secure anonymized databases is essential to facilitate retrospective analysis.

Conclusion: The Companion Animal Tumour Sample Bank was established in 2009 as the first of its kind in Canada. While the primary focus has been oncology samples, the scope of the biobank is expanding to include other areas of interest, evolving into the Ontario Veterinary College Veterinary Biobank (OVCVB). With informed client consent, samples and relevant clinical data are collected. Currently OVCVB has almost 2,000 cases and continues to grow, including serum, plasma, buffy coat, urine, and tissue. A wide variety of neoplasms have been collected: the most prevalent in dogs are soft tissue tumour (STT), lymphoma, and osteosarcoma (OSA); in cats, STT, mammary carcinoma, and OSA. Samples and data from the OVCVB have been used in 36 internal and external projects, including biomarker analysis and test validation. The OVCVB is a unique resource with the mission to facilitate research to improve the lives of companion animals through the collection and distribution of patient samples and clinical data. Through initiatives such as the Ontario Biobank Network and regulatory bodies such as CTRNet, increased awareness of disease similarities in humans and pets and improved quality of sampling allow for greater access to samples that contribute to more impactful translational research.

Biospecimen Research, Science and Outputs

PE-01 Current NCI Funding for Biospecimen Science

A. Rao, L. Agrawal, P. Guan, M. Ossandon, H. Moore

National Cancer Institute, Bethesda, Maryland, United States

Statement of the Problem: The methods to collect, process, and store tissue and liquid biopsies donated by cancer patients can vary widely across research laboratories and clinical sites. Preanalytical variability introduced during biospecimen handling can affect the reliable assessment of biomarkers and subsequent analysis. It is critically important to learn more about preanalytical factors that may compromise the accuracy of clinical assays important for patient diagnosis.

Proposed Solution: The Biorepositories and Biospecimen Research Branch (BBRB) of the National Cancer Institute has a long-standing history of supporting biospecimen science. BBRB currently supports studies that examine how preanalytical factors introduced during biospecimen handling affect clinical biomarker assay performance. To date, 21 awards have been funded covering a variety of cancer types, biospecimen types, and analysis platforms.

Conclusions: The funded program aims to better understand whether and how different methods of biospecimen handling practices affect molecular integrity and downstream data as measured by specific biomarkers and analytical platforms. Optimization of preanalytical workflows to improve biomarker validation and assay development is also of significance to the program. The funding opportunity has successfully been renewed and investigators are encouraged to apply with receipt dates beginning in February of 2025 and ending in September of 2027. Data and publications from the program will further develop the body of knowledge that describes the contribution of specimen preanalytical factors to clinical assay variability and reproducibility. Importantly, the program will continue to engage multiple grantees across the cancer research and diagnostics community to systematically investigate and solve critical biospecimen preanalytical issues facing the research community.

PE-02 Tumor Biobank Enhanced by Digital Pathology and AI in Developing Countries

A. Saini^{1, 2}

¹Biobank, CNC PATH LAB, New Delhi, India, ²Pathology, Smart Salem, Dubai, United Arab Emirates

Background: Tumor biobanks are vital for oncology research, providing annotated specimens essential for understanding tumor morphology, mutation profiles, and treatment response patterns. However, developing countries often lack robust biobanking infrastructure, limiting local cancer research capabilities. The CNC PATH LAB Tumor Biobank addresses these challenges by using digital pathology and artificial intelligence (AI) to enhance specimen description, optimize quality control, and streamline data analysis, thereby strengthening oncology research in resource-constrained settings.

Methods: CNC PATH LAB established a biobank integrating digital pathology and AI to support comprehensive specimen management, analysis, and annotation. Digital pathology technology captures high-resolution images of tumor specimens, enabling remote access and reducing specimen handling. AI-driven algorithms assist in identifying key histopathological features, including tumor grade, morphology, and mutation patterns, and provide predictive analytics based on these digital images. All tumor samples are arranged with detailed patient demographics, mutation profiles, and clinical data, stored in a secure database accessible to national and international research collaborators.

Results: The biobank currently houses over 5000 tumor samples across various cancer types, including lung, breast, and colorectal cancers, with digital annotations enriched by AI-powered analysis. The integration of AI has improved diagnostic accuracy in mutation identification by 90% and reduced specimen processing time by 70%, facilitating faster, high-quality data generation. This model has also supported collaborative studies, contributing to region-specific insights into tumor mutation and treatment response, which are instrumental in guiding precision medicine initiatives tailored to local population needs.

Conclusions: The CNC PATH LAB Tumor Biobank represents a pioneering model for integrating advanced technologies in biobanking within developing countries. By combining digital pathology with AI, it overcomes conventional barriers in specimen collection, studying, processing, and data processing, enhancing cancer research and collaboration opportunities. This scalable model has the potential to drive transformative improvements in cancer research infrastructure, supporting precision oncology and improving healthcare outcomes across developing regions.

PE-04 From Storage to Study: SOH Biobank’s Commitment to Supporting Research

R. Mohamed, A. M. Gamal, M. Saady, S. Aboelela, A. Ramadan, A. Saleh

Shefaa Al Orman Oncology Hospital, Luxor, Egypt

Introduction: Biobanks are essential to advancing modern research by supplying researchers with high-quality biospecimen and associated data, supporting studies across diverse fields such as genetics, epidemiology, and oncology. The availability of well-preserved, carefully managed samples is a cornerstone for scientific progress, especially in fields like personalized medicine and biomarker discovery, where specific sample quality is critical. By releasing biospecimen, biobanks facilitate sample collection for research.

The Shefaa Al Oman Hospitals (SOH) Biobank exemplifies this role by acting as a pivotal resource for scientific studies through its provision of high-quality biological samples for a broad range of research studies. This abstract reflects our experience in samples management and distribution, emphasizing how these efforts facilitate a wide array of research activities.

Methods: First, research proposals are submitted to the scientific committee for review. Once approved, they proceed to the Institutional Review Board (IRB) for further evaluation. Following IRB approval, a formal sample request is submitted to the biobank. The biobank team then reviews the request to confirm that the requested samples are available. Upon verification, the biobank team prepares and provides the samples to the principal investigator, who signs a receipt of received samples.

Results: In 2024, the SOH Biobank provided a total of 442 samples to support eight different studies. The released samples included 184 plasma samples for lung cancer research, 138 serum samples for colorectal cancer studies, 61 serum samples for liver cancer research, 51 samples for a chronic lymphocytic leukemia study, and eight tissue samples for bladder cancer research.

Of these studies, two have already been published, one is currently in the publication process, and the remaining studies are actively in progress. This contribution highlights the critical role of the SOH Biobank in facilitating impactful research across various areas of medical science.

Conclusion: The SOH Biobank plays a vital role in advancing medical research by providing high-quality biospecimens. In 2024, it supported eight studies across various cancers, contributing to published and ongoing research. This work highlights the biobank’s essential contribution to studies in personalized medicine and biomarker discovery, underscoring its impact on scientific and healthcare advancements.

PE-05 RNA Sequencing from Small Biopsy Specimens: Challenges and Best Practices

L. Agrawal¹, S. Gloria², K. Engel¹, S. Greytak¹, A. Rao¹, P. Guan¹, M. Ossandon¹, S. Ghatak³, P. Abbosh⁴, S. Gaston⁵, M. Arcila⁶, K. Bomsztyk⁷, R. Clark⁸, K. Dillehay McKillip⁹, F. Symmans², H. M. Moore¹

¹National Cancer Institute, Bethesda, Maryland, United States, ²MD Anderson Cancer Center, Houston, Texas, United States, ³National Cancer Institute, Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States, ⁴Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, ⁵University of Miami Miller School of Medicine, Miami, Florida, United States, ⁶Memorial Sloan Kettering Cancer Center, New York, New York, United States, ⁷University of Washington, Seattle, Washington, United States, ⁸Brigham and Womens Hospital, Boston, Massachusetts, United States, ⁹University of Cincinnati, Cincinnati, Ohio, United States

Statement of the Problem: RNA sequencing from minimally invasive procedures—such as fine needle aspirations, small biopsies, and exfoliative specimens—offers a powerful method for analyzing gene expression patterns and detecting RNA-level changes associated with various cancers. However, there is no universally accepted “gold standard” for RNA specimen handling, as protocols and best practices are still evolving. Researchers face several challenges in obtaining reliable results, including issues with sample quality and quantity, cellular heterogeneity, batch effects, and RNA extraction methods. Furthermore, since there is no one-size-fits-all approach, it is crucial to tailor procedures to the specific requirements of the intended downstream applications.

The U.S. National Cancer Institute (NCI) sponsors research on the pre-analytic considerations of various biospecimen types and analytical platforms used in clinical biomarker assays, with the goal of developing the data to support best practices for biospecimen handling and standardization. A dedicated working group on “RNA Sequencing from Biopsy Specimens” has been established to identify and address the challenges and opportunities in standardizing RNA research methodologies.

Proposed Solution and Methods: The working group is reviewing existing literature, resources, and researcher experiences to identify best practices for pre-analytic procedures, focusing on key areas such as specimen collection, processing, nucleic acid extraction, storage, library preparation, and platform selection for specific downstream applications. Through coordinated efforts, the team aims to pinpoint unanswered questions and address gaps, with a particular emphasis on pre-analytical factors.

Conclusions: The working group employs a collaborative and systematic approach, incorporating expert review, to develop best practices and recommendations. The goal is to ensure that the final recommendations are evidence-based, practical, and broadly applicable in laboratory settings. These guidelines will serve as a foundation for creating standard operating procedures to optimize biospecimen handling for RNA sequencing applications.

PE-06 High-throughput Fluorescence Assay for Plasma Quality Measurements in Biobanks

D. Hernandez², C. Climer², C. Huynh², V. Ramanujan^{2, 1}

¹Academic Affairs and Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California, United States, ²Biobank and Research Pathology, Cedars-Sinai Medical Center, Los Angeles, California, United States

Background: Human blood plasma has been ubiquitously isolated and banked in a number of biobanks across the world, owing to its ease of collection and isolation with relatively low investment. Plasma specimens have contributed to development of therapies and medical diagnostic kits. By profiling thousands of proteins in very small volumes, the modern proteomics technologies have further accentuated on the utility of plasma specimens in drug discovery. As the blood processing protocols and practice can differ significantly across the biobanks, it is imperative that plasma quality metrics need to be standardized, so that sophisticated proteomic profiling methods are leveraged to their fullest potential and the data shared across various research labs bear meaningful outcomes. This brings the need for reliable and effective plasma quality measurements.

Methods: Current quality control measures for blood samples often rely on liquid chromatographic separations and/or mass spectrometry, which can be an expensive endeavor for smaller biobanks. In order to facilitate rapid assessment of plasma quality and cost-effectiveness that can be easily deployed in any biobank setting, we have developed a fluorescence-based assay for detecting plasma specimen quality. The principle of this method is based on a fluorescent-indicator of redox molecule glutathione (a potential red blood cell contaminant) in isolated plasma specimens.

Results: We have demonstrated the efficacy of this assay in plasma specimens from cancer patients and the assay sensitivity was found to reflect physiological levels of glutathione contamination in plasma specimens. A 96-well plate format for rapid assessment of plasma concentration as well as plasma quality has been tested and this may add value as a high-throughput plasma quality monitoring platform even in a small-size biobank setting. In this poster, we will discuss the workflow to ensure that the plasma specimens are fit-for-purpose for various downstream assays in the context of both targeted and unbiased proteomics.

Conclusions: A cost-effective, sensitive fluorescence-based assay for checking plasma-specimen quality in a high-throughput fashion has been developed, tested, and validated using human plasma specimens in a hospital-based biobank. By complementing this assay with other blood derivative quality metrics, it is possible to harmonize the blood QC pathway in biobanks and to create impact in biospecimen research discoveries.

PE-07 Quality Plan for Optimizing Preservation and Storage of Mycobacterium tuberculosis Isolates in a Biorepository

N. Jawaid¹, N. Khursheed², S. Hussain^{1, 3}, M. Dojki², S. Asif⁴, J. Aijaz^{1, 3}

¹Biorepository, Indus Hospital & Health Network, Karachi, Pakistan, ²Clinical Laboratories, Indus Hospital & Health Network, Karachi, Sindh, Pakistan, ³Molecular Pathology, Indus Hospital & Health Network, Karachi, Sindh, Pakistan, ⁴Mycobacteriology, Indus Hospital & Health Network, Karachi, Sindh, Pakistan

Introduction: Biobanking of Mycobacterium tuberculosis (MTB) isolates is essential for TB research and diagnostics. However, a standard quality plan for MTB cryopreservation and subsequent DNA extraction does not exist. This study aims to implement a quality plan for MTB isolate viability, prevention of contamination, as well as subsequent DNA extraction quality to ensure high-quality samples for research and diagnostic use.

Methodology: A total of 2110 MTB isolates retrieved from −70 C to −80 were sub-cultured on solid media. Genomic DNA was extracted using the cetyl trimethylammonium bromide (CTAB) method and spectrophotometric measurements were taken to quantify DNA concentration and purity for downstream analysis. Isolate revival and DNA quality data were analyzed and a quality plan was implemented to increase the viability and sterility of preserved isolates.

Results: Of the isolates inoculated, 1606 (76.1%) were successfully revived, 31 (1.5%) were contaminated, and 445 (21.1%) showed no growth upon subculture. Seventeen isolates were identified as mycobacteria other than tuberculosis. DNA extraction was done for n=1548 isolates. Of those 1324 (85%) had a DNA concentration >100ng/µL DNA, while the remaining 224 (15%) had <100 ng/µL. Additionally, 763 (49%) had 260/280 between 1.8-2.0. To increase the viability of stored isolates, each preservation batch undergoes sterility testing and viability testing on Lowenstein-Jensen and MGIT (Mycobacteria Growth Indicator Tube) media. Isolate preservation follows defined timelines. Freezer temperatures are monitored every four hours by JRI data logger device and data analyzed monthly. Internal audits are conducted bi-annually, with additional random monthly audits.

Conclusion: The QC plan has provided a structured framework for maintaining the viability and sterility of MTB isolates, ensuring consistent storage conditions and compliance with biobanking best practices. It will offer a reliable, replicable approach to preserving MTB samples for research and diagnostic purposes, maintaining the highest standards of sample quality.

PE-08 Thermal Excursions of Cryogenically Frozen Vials (below −150 C) and the Risk of Rising Above Tg,H₂O: Analyzing Warm-Up Rates from Cryogenic Storage to Both Dry Ice and Ambient Temperature Environments

E. Waller

Azenta US Inc, Burlington, Massachusetts, United States

Background: Many biological samples are stored at cryogenic temperatures (i.e., temperatures below −150 C) to preserve their viability. Typically, these samples are stored in liquid nitrogen vapor-phase freezers. The underlying assumption is that biological samples show highly reduced degradation and metabolic activity while below Tg (the glass transition temperature). On the other hand, every time a sample is manipulated or temporarily removed from an LN₂ freezer, the sample will experience thermal excursions marked by warm-up rates of several degrees per second. In these cases, the risk of harming a sample by inadvertently crossing the Tg threshold is very likely.

Methods: This study will provide supporting data to fully characterize the thermal excursions of cryogenically frozen single vials filled with H₂O during typical transient temperature events. We expect the measurements operated on H₂O-filled vials to be representative, in their order-of-magnitude, of the thermal response of vials filled with a broad range of bio-materials. Further testing will be soon undergoing to confirm the claim. Here, we focus our attention on the cold-chain steps that involve transferring a single vial from an LN₂ vapor environment to either an ambient temperature (room temperature) or transportable dry ice (-80 C) environment.

Results: In general, the warm-up rates experienced by the biological sample correlate to the thermal energy exchanged with the warmer environment via convective, radiative, and conductive heat transfer. The magnitude of the heat transfer is driven by multiple factors: the warmer environment temperature and the overall time of exposure, the size and shape of the vial, the volume of H₂O in the vial, its placement in a cryobox, the type of handling (manual or automated), etc.

Conclusion: In this study, we rationalize all the above factors and present experimental measurements supported by calibrated finite element simulations showing typical expected warm-up rates. As a result, best-practice time constants for handling vials of biological samples without risking excessive thermal excursions above the glass transition temperature of H₂O (Tg,H₂O) are suggested.

PE-09 Assessment of SARS-CoV-2 RNA Stability in Biorepository Samples: Impact of Long-Term −80 C Storage and Room Temperature on Ct Values

S. Ali¹, A. Zaid¹, F. Naseer¹, N. Jawaid², J. Aijaz^{2, 1}

¹Molecular Pathology, Indus Hospital & Health Network, Karachi, Sindh, Pakistan, ²Biorepository, Indus Hospital & Health Network, Karachi, Sindh, Pakistan

Introduction: Biorepositories play a crucial role in infectious disease research by storing biological samples for longitudinal studies and retrospective analyses. The stability of viral RNA, particularly under varying storage conditions, is a significant factor influencing the accuracy and reliability of diagnostic tests over time. Understanding the effects of long-term storage on SARS-CoV-2 RNA stability, especially under conditions where samples are transitioned from ultra-low temperatures to room temperature, is essential for ensuring accurate downstream molecular analyses.

Objective: This study aimed to evaluate the stability of SARS-CoV-2 RNA nasopharyngeal samples stored in viral transport medium under prolonged storage at −80 C and subsequent exposure to room temperature.

Material and Methodology: SARS-CoV-2 RNA was detected through real-time PCR on Cepheid GeneXpert system. Forty-five pooled, archived patient samples, stored at −80 C from 2021-2022, were maintained at room temperature and re-tested in April 2023. Each sample was tested over 20 consecutive days, organized into 40 batches: 45 samples processed each morning and another 45 each evening. The cycle threshold (Ct) values for the E and N genes were subsequently evaluated.

Results: Upon retrieval from −80 C storage, the initial analysis showed no Ct value for the E gene in four samples, while all samples initially showed detectable Ct values for the N gene. After one day of storage at room temperature, the Ct value for the E gene dropped to 0 in 12 samples, while only one sample displayed a Ct of 0 for the N gene. These results suggest that the E gene is more sensitive to Ct value fluctuations due to room temperature exposure than the N gene. Among the 45 samples, 11 showed Ct value deviations for the E gene, compared to only eight for the N gene.

Conclusion: Our findings demonstrate that SARS-CoV-2 RNA stability in biorepository samples is affected by storage conditions, with room temperature exposure impacting Ct values more significantly than long-term storage at −80 C. The E gene was particularly susceptible to degradation, as indicated by the increase in no Ct values following room temperature exposure, in contrast to the N gene, which showed less sensitivity. Overall, these results highlight the importance of consistent low-temperature storage to preserve RNA integrity, especially for E gene assays.

PE-10 Socio-Demographic and Health-Related Characteristics of the PROCURE Biobank Participants, a Biobank for Prostate Cancer Research

G. McKercher¹, A. Bergeron³, S. Chevalier¹, A. Mes-Masson⁵, A. Piché⁴, F. Brimo², M. Latour⁵, N. Ekindi-Ndongo⁴, M. Carmel⁴, L. Lacombe³, F. Saad⁵, A. Aprikian²

¹Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada, ²McGill University Health Centre, Montreal, Quebec, Canada, ³Centre hospitalier universitaire de Québec-Université Laval, Quebec, Quebec, Canada, ⁴Centre intégré universitaire de santé et de services sociaux de l’Estrie, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada, ⁵Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada

Background: Translational prostate cancer research requires access to high-quality biospecimens and clinical data. However, since lifestyle plays an important role in prostate cancer etiology, socio-demographic data should be considered to better stratify patients and control confounding effects. The PROCURE Biobank is a multi-site biorepository of biospecimens and clinical and socio-demographic data of patients undergoing radical prostatectomy (RP) for their cancer and who are followed longitudinally during remission or recurrence of their disease.

Methods: Ethics approval of the four participating universities/hospital centers in the province of Quebec was obtained. Operating documents included: a consent form, a questionnaire on socio-demographics, lifestyle habits and diseases, standard operating procedures, and worksheets.

Results: From 2006 to 2013, the biobank enrolled 2007 men. Biospecimens obtained at RP were banked and clinico-pathological data were collected. Follow-up visits permitted biospecimen recollection and clinical data update. We selected among the Biobank participants those providing a complete case (i.e., with biospecimens, pathological, clinical and follow-up data, and questionnaire completed) and ended up with 1812 participants (90%).

To date, 619 of these participants had a biochemical recurrence (34%), and 233 deaths (13%) were recorded, among which 51 (2.8%) were due to PCa.

The following data are available from the questionnaire:

1)

Personal information (racial and ethnic origin, civil status, education, occupation or profession).

2)

Information relative to diagnosis (prior and after).

3)

Lifestyle information (alcohol consumption, tobacco use, physical activity, anthropometric data, nutrition habits and supplement intake).

4)

Clinical information (co-morbidities, family history of cancer).

The typical participant of the PROCURE Biobank has the following profile: a Caucasian man in his sixties, who was born and who has lived in Quebec province most of his life; he is married, is semi-retired, was a regular smoker, is devoting three to four hours per week to physical activity, and has some extra weight (mean body mass index of 27). He has 34% risk of having a relative (father, brother, uncle) with prostate cancer.

Conclusions: The available clinical, follow-up (more than eight years) and socio-demographic data makes the PROCURE biobank a precious tool to evaluate the impact of demography and lifestyle on the characteristics and the progression of prostate cancer patients.

PE-11 Investigating Long-Term Storage Stability of TNF-α and IL-6 Plasmatic Concentrations in a Psychiatric Sample and Provide Strategies to Mitigate Potential Degradation: The Signature BioBank

E. Cipriani, C. Giguere, S. Guay, R. Juster

Centre de recherche de l’Institut universitaire en santé mentale de Montréal, Montreal, Quebec, Canada

Background: Chronic inflammation is increasingly recognized as an important factor influencing mental health. Blood IL-6, TNF-α and CRP are the best-known biomarkers of acute inflammation. These cytokines are also used as markers of the inflammatory component of the allostatic load, the accumulation of chronic stress. Biobanks enable easier access to large samples offering the possibility to study such biomarkers in psychiatric disorders. However, long-term storage may result in degradation of sample quality and pre-analytical biases in data. Existing research have not addressed the impact of long-term (+4 years) storage on cytokine concentrations in biobanked human plasma.

Methods: Here we analyzed circulating IL-6 and TNF-α in the stored plasma of the Signature Biobank collected between 2012 and 2020. We tested the correlation between IL-6 and TNF-α concentrations and storage length among the entire available data (n=1203 for IL-6 and n=1220 for TNF-α, respectively). We also evaluated in a subset of sample sets (n=50), for cytokine measures at two-time points separated by 32 or 45 months.

Results: In the large biobank set of samples we identified a slight negative correlation (r = −0.215; p<0.001) for TNF-α indicating a slow degradation with longer storage. Correlation was not significant for IL-6 (r = −0.034, p=0.24). A corrective equation was extracted from this analysis and applied to TNF-α in the subgroup but did not improve the test-retest quality. In the retest study, we observed a moderate to strong stability of measures (rTNF-α=0.61; rIL-6=0.71) between both storage periods with a slight, but not significant, higher concentrations of IL-6 and TNF-α for the second time of measure (32 or 45 months). Several statistical manipulations were provided to have a clearer picture of the potential degradation process: stratification depending on storage time between analyses, controlling for initial storage length, excluding outliers allowing better correlation coefficients (r=0.94 and r=0.76, for IL-6 and TNF-α, respectively).

Conclusion: Long-term storage induces degradation patterns depending on the analyte, with a non-linear degradation pattern for IL-6 and faster degradation for TNFs. This degradation effect could be mitigated by integrating the age of the sample in statistical analyses. Systematic and rigorous quality controls across time must be done regularly in biobanked samples to avoid bias and detrimental impact on research data.

PE-12 Precision Aliquoting Supports Spatial Tracking and Longevity of Human Tissue Samples for the Somatic Mosaicism across Human Tissues (SMaHT) Network Biobank

I. Sleeman, A. Hasan, K. Leonard, T. Bell, M. VonDran

National Disease Research Interchange, Philadelphia, Pennsylvania, United States

Background: The Somatic Mosaicism across Human Tissues (SMaHT) project will establish the first comprehensive public resource cataloguing genetic variation due to somatic mosaicism. The SMaHT Tissue Procurement Center (TPC) will provide high-quality human biospecimens from deceased adult donors and establish the SMaHT Biobank. Due to the enormous amount of cell mixing and migration that occurs across the lifespan, spatially linking molecular analyses from a given tissue sample is a critical scientific need for the program. A proof-of-concept study is presented here to determine how a precision aliquoting approach will support the experimental needs of the SMaHT Network.

Methods: Tissue samples from all three developmental layers were recovered from deceased donors utilizing standardized recovery protocols. Immediately after excision, multiple aliquots of each tissue site were snap frozen. The TPC utilized a CXT 353 Frozen Sample Aliquotter for subsampling each aliquot to distribute cores to the SMaHT Network investigators. This instrument is a semi-automated bench-top instrument that can extract multiple frozen cores from a single sample. A grid-mapping system was utilized to prepare tissue samples for aliquoting and maintain spatial detail. Using two extraction bore-sizes (1.5 mm and 3.0 mm), the TPC extracted and distributed tissue cores to investigators. Nucleic acids were extracted from the cores for RNA, DNA, and sequencing analyses.

Results: The TPC workflow for precision aliquoting includes imaging of frozen tissue samples both before and after aliquoting. A grid map is utilized to pre-label tubes for core collection, which differs based on extraction bore size. The TPC was able to extract 7-18 cores per tissue aliquot (1 cm × 1 cm × 1 cm). All investigators were able to extract DNA and RNA from the frozen tissue cores using the precision aliquoting approach. However, variable results were identified across groups depending on the extraction method. For most molecular methods, the 3.0-mm core size was best able to isolate the quantity of DNA/RNA for analysis.

Conclusion: The SMaHT TPC validated that a precision aliquoting methodology meets the experimental needs of the Network. The use of precision aliquoting will provide several long-term benefits for the SMaHT Biobank. It will: 1) maximize SMaHT biobank sample utilization, 2) support spatial tracking in molecular analysis, and 3) expand the impact of each generous donation for donor families.

PE-13 Optimizing Prostate Cancer Tissue Sampling: MRI and Puncture Biopsy Reports Improve Tumor Cell Content of the Tissue Collected by Biobank

B. Liu, Q. Wang, M. Xu

Biobank, Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Background: Ensuring high tumor cell content in biobank specimens is critical for downstream molecular research, including genomics and proteomics. Traditional macroscopic inspection often fails to meet the stringent tumor-rich criteria needed for advanced analyses. This study evaluates the effectiveness of magnetic resonance imaging (MRI)-guided and puncture biopsy-guided sampling methods in optimizing tumor cell content in prostate cancer specimens.

Methods: A retrospective analysis was conducted on 300 prostate cancer patients who underwent radical prostatectomy at Fudan University Shanghai Cancer Center between 2023 and 2024. Patients were categorized into three groups: the MRI-guided group (n=100), the biopsy-guided group (n=100), and the control group (n=100) relying on macroscopic visual inspection. Tumor-rich areas were identified using MRI and biopsy reports for targeted sampling. Tumor cell nucleus percentages were assessed via hematoxylin-eosin (H&E) staining, and chi-square tests and logistic regression analyses were conducted to compare qualification rates (≥20% and ≥50% thresholds).

Results: The MRI-guided and biopsy-guided groups demonstrated significantly higher qualification rates compared to the control group. For the ≥20% tumor cell threshold, qualification rates were 77% (MRI), 79% (biopsy), and 53% (control) (P < 0.0001). For the ≥50% threshold, qualification rates were 60% (MRI), 56% (biopsy), and 29% (control) (P < 0.0001). Logistic regression analysis further confirmed the superiority of MRI and biopsy-guided methods, with significantly higher odds ratios compared to the control.

Conclusions: MRI and biopsy-guided sampling significantly improve the accuracy and quality of prostate cancer specimen collection for biobanking, ensuring higher tumor cell content. These methods offer a robust solution for meeting the rigorous requirements of molecular research and advancing translational oncology.

PE-14 Specimen Handling Methods for Optimizing Microplastic Investigations in Pediatric Surgical Patients

W. Schleif^{1, 2}, J. DeRosa³, A. Ford³, A. Green³, R. Heromin³, V. Ignjatovic¹, D. Voronin⁴, C. Snyder^{5, 3}

¹Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, United States, ²Pediatric Biorepository, Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, United States, ³Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, United States, ⁴Physics, University of South Florida College of Arts & Sciences, Tampa, Florida, United States, ⁵Surgery, Johns Hopkins Medicine, Baltimore, Maryland, United States

Statement of the Problem: Microplastic (MPS) accumulation in pediatric patients is a phenomenon of concern with unknown impact on normal childhood development and clinical outcomes. MPS are defined as plastic particles between 5mm and 1 micron in size. MPS have been detected in many specimen types, including urine, blood, feces, breast milk, placenta, and lung. To investigate MPS-associated issues, biospecimens must be handled using carefully controlled methods that account for potential plastic contamination after specimen exposure to collection devices, labware, and hospital environments.

Proposed Solution: In this pilot study of up to 150 patients, we collected whole blood and urine from consented pediatric patients undergoing general surgical consultation/evaluation in the outpatient or inpatient setting. Although no standardized methods currently exist for human subjects microplastic research, other investigators have published MPS-specific approaches utilizing environmental specimens, as well as the control procedures required to account for MPS-associated background, which we utilized as a baseline for our optimized methods. In brief, we utilized plastic-free EDTA vacutainers to collect blood in parallel to a water control specimen for each specimen. These were centrifuged, and the plasma and cell layers further degraded using various reducing agents to isolate MPS from biological conjugates that hinder identification. Urine specimens were collected using a glass and metal collection system designed by the study principal investigator, and a water control was also collected in the same area using the same device. The urine and control specimens were similarly degraded using a reducing agent. After a 24-hour incubation, blood and urine specimens, alongside controls, were each concentrated onto ∼1-μm pore size filters for microscopic examination. MPS were further characterized using Raman microspectroscopy and further identified using Raman spectral reference profiles to define their origin.

Conclusions: We share our optimized methods for the identification of microplastics in pediatric blood and urine specimens. We determine research processes adopted from environmental sampling (e.g., water, soil) require additional steps to properly identify and characterize MPS quantities and morphology isolated from human sources, and collection of parallel control specimens are essential for understanding potential MPS contamination from hospital environments.

PE-15  

PE-16 The Mathison Centre Neurogenetics Biobank and Advancing Precision Mental Health

S. Shaheen

Psychiatry, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada

Background: Neurogenetics Biobank is a research biobank that includes collaborators, multiple research institutes, and studies based in the community and the clinic. The aim of the biobank is to support gene discovery and knowledge translation in child and youth mental illness and precision medicine approaches.

Method: The Biobank features include controlled rate freezing, sample storage and transfer, ethics and biosafety, data preservation, documentation, and consultation. Neurogenetics Biobank is currently focusing on major areas:

1)

Developing an outline of the types of bio-specimens regularly collected, stored, retrieved, and distributed in a biobank (https://www.bcplatforms.com) system and the procedures involved with strict standard operating procedures (SOPs) to ensure sample quality fits the purpose of use.

2)

Implementing a specimen data and record management system for internal and external stakeholders, using an automated method, which ensures secure collection, storage and retrieval of genetic and phenotypic data.

Research Involvement with Biobank: 1)

Gene & Environmental Influences on Behaviour and Cognition in Childhood Neuropsychiatric Disorders.

2)

PGx -Spark: The Discovery of Pharmacogenetics Markers and Tools for Child and Youth Mental Health. The aim of this project is to implement Canada’s first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.

3)

Harnessing the Power of Population-Based Samples for Detecting Gene x Environment Interactions.

4)

Brain Function and Genetics in Pediatric Obsessive-Compulsive Behaviors.

5)

Genetic Architecture for Youth Anxiety, a pan-Canadian study. Funding includes multiple sources including the National Institutes of Health, Canadian Institutes of Health Research, Canadian Foundation for Innovation, the Mathison Centre, Hotchkiss Brain Institute, and Alberta Children’s Hospital Foundation.

Results: To date, the Biobank has successfully stored 5455 clinical bio-specimens (DNA from blood, saliva, and buccal swabs) from eight different sites. The Biobank system has also established a database system focused on sample tracking, phenotype-genotype linkage, and health information for different users in Canada and the United States.

Conclusion: Neurogenetics Biobank applies dynamic approaches to gene discovery and precision medicine. We emphasize project engagement and return of value to participants, collaborators, and other stakeholders.

PE-17 The Optimal OCT Tissue Storage Temperature for Biobanking and Spatial Transcriptomics

K. McCortney¹, J. Walshon¹, A. Steffens¹, M. Gomez Hjerthen¹, M. W. Youngblood¹, C. Horbinski²

¹Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, ²Pathology, Northwestern Memorial HealthCare, Chicago, Illinois, United States

Background: Biobanks need to remain up-to-date with the ever-changing landscape of scientific technology. One of the latest developments in tissue imaging and analyses is spatial transcriptomics, with many platforms requiring tissue preserved in optimal cutting temperature (OCT) medium. This is a challenge for biobanks, because most tissue blocks are preserved via formalin-fixed paraffin-embedding (FFPE), in both clinical and research settings. FFPE tissues are generally not suitable for transcriptomics platforms, thus necessitating additional biobanking of OCT samples.

Method: Our team at the Northwestern Nervous System Tumor Bank (NSTB) determined the optimal conditions for OCT preparation and storage. While −80 C is often used for the storage of OCT blocks, we found that tissue degradation is noticeable on sections when the tissue is repeatedly alternated between storage at −80 C and sectioning at −20 C. One sample was sectioned five days after storage at −80 C and then again one month later. A second sample was sectioned 10 days after storage at −80 C and then again one year later.

Conclusion: In both instances, the second sectioning time point contained larger areas of freeze artifact. Our data therefore suggest that OCT samples should not be stored at −80 C, and instead should be stored at −20 C. In total, the NSTB has banked over 75 cases with OCT tissue. Additional experiments are ongoing to determine the lifespan of a sample stored at −20 C.

Ethical, Legal, and Social Issues

PF-01 Informed Consent Forms Shouldn’t Be Reminiscent of a Software’s Terms and Conditions

H. Ellis

Biobanking Without Borders, LLC, Durham, North Carolina, United States

Statement of the Problem: Have you read the iTunes Terms and Conditions in its entirety? Probably not, because when printed using 8pt font, it’s 32 feet long. The informed consent form (ICF) is a crucial step in the informed consent process, yet ICFs are often too lengthy, overly complex, and contain unnecessary information that may not be important to participants. Most of us are educated professionals and are used to writing with sophistication to communicate and even impress the reader. If a potential participant doesn’t fully understand everything in the ICF, there are three possible outcomes.

1)

They take the time to ask questions and get a better understanding, and then make an informed decision.

2)

They get discouraged and overwhelmed, and decline to participate out of frustration.

3)

They glance through the form and agree to participate, without fully grasping all of the content. The days of copying and pasting dense language from another ICF because it was previously approved are over. We have an ethical obligation to provide an easy-to-understand ICF to our potential participants.

Proposed Solution: We must use plain language principles when writing ICFs. There are many publicly available resources that teach plain language principles as well as tools, tips, word lists, and example language. Time and attention should be given to the language in required sections such that they are easier to understand by the potential participant, so that the inclusion of the language isn’t solely to tick a box on a checklist. For example, authorization for use of one’s health information for research in the U.S. (HIPAA) often duplicates information that is already in a biobanking ICF. And, although there is a U.S. law for protection from discrimination due to one’s genetic information (GINA), it’s complicated and most people have other concerns about their participation.

Conclusion: Too often information required by regulations or local ethics committees are written in “legalese” to protect the institution, but don’t bring value to the informed consent process. Plain language principles should be used when writing research ICFs, and important content can be written clearly using existing tools and principles.

PF-02 Protecting Privacy - African Data Regulations

E. S. Mayne^{1, 2}

¹Pathology, University of Cape Town Faculty of Health Sciences, Observatory, Western Cape, South Africa, ²Immunology, National Health Laboratory Service, Johannesburg, Gauteng, South Africa

Background: The European General Data Protection Regulations (2016) have implications for data transfers and collection including that collected with biospecimens. The regulatory environment is less well understood in Africa although the African Union published the Malabo Convention on Cyber Security and Personal Data Protection (2014).

Methods: A scoping review was performed of African data protection regulations with specific reference to research and data storage and processing as well as transfer of data out of countries.

Results: Of 54 countries surveyed, 18 countries currently have not enacted data protection laws. A further six countries have enacted laws but have not appointed data protection officers/data regulators. Early adopters of data protection include Cabo Verde (2000) and Tunisia (2004). Most countries do have exemptions for research although many require complete de-identification and may require verbal or written consent. In some cases, long term data storage even for scientific purposes is restricted although many laws allow long-term storage of data for research. Individuals typically have rights to have data corrected or deleted. Most transfers require demonstration of equivalent protection in the receiving country. Some countries prohibit transfer or require for storage and processing to occur within country.

Conclusion: Understanding the regulatory environment is critical to facilitate the storage and transfer of data related to human biospecimen collections.

PF-03 Opportunities and Challenges in a Groundbreaking Research Programme – an Ethics Perspective

A. Parry-Jones

Our Future Health, Manchester, United Kingdom

Background: Our Future Health (https://ourfuturehealth.org.uk/) started to recruit participants in the UK in October 2022 and has the goal to consent up to five million people. The sheer scale and ambition of the programme, coupled with the rapid expansion since inception, presents huge research opportunities but also introduces challenges to ensure ethical principles and management are at the forefront and core of the organisation. An external Ethics Advisory Board is in place with an Ethics and Governance Framework to give guidance and act as “critical friends.” A dedicated Ethics team sits within the Ethics, Compliance, and Governance group of the organisation.

Methods: Participants follow a digital consent process and complete a comprehensive questionnaire. They attend specific Our Future Health clinics to donate blood samples and have physical measurements taken, which are fed back to them at the appointment. Biosamples and data are stored for future use and researchers worldwide can apply to access the data from the trusted research environment. In addition to data studies, Our Future Health will facilitate access to stored biospecimens for disease-specific biomarker discovery and validation, as well as selective invitation of participants to additional studies and trials.

Results: Two million participants have consented to Our Future Health in the 26[MC1] months of recruitment, making it the largest research programme of its type in the world. Over half have so far completed the questionnaire and donated blood samples. The consent allows for recontact for future questionnaires and donation of other samples but inclusion in additional studies and trials will be separate, project-specific consents.

Conclusion: A strong relationship with the approving Research Ethics Committee and forward planning for upcoming initiatives within the programme are vital. This presentation will examine some of the ethical issues encountered and anticipated, such as consent and withdrawal, feedback of genomic and other results, and recontacting participants.

PF-04 Development of a Patient Advocate Committee for the Kids Eye Biobank

F. Argento¹, I. Ristevski¹, K. Flegg¹, H. Dimaras^{1, 2}

¹Department of Ophthalmology and Vision Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, ²Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada

Background and Aims: The Kids Eye Biobank holds an international collection of biospecimens, images, and clinical data for use in future research. Patient engagement in research is a top priority of the Kids Eye Biobank. This study describes the development of a patient advocate committee (PAC) for the Kids Eye Biobank.

Methods: Patients (defined as anyone with lived experience of pediatric eye disease) contributed to the design of the Kids Eye Biobank and co-wrote funding applications. This included creating an initial patient engagement plan and a Terms of Reference to outline PAC membership. Once the Kids Eye Biobank was established, PAC members were recruited through advertisement to relevant patient groups. The PAC held regular meetings to prioritize tasks and revise and implement the patient engagement plan.

Results: As of November 2024, the PAC has six members; five live in North America and one member lives outside of North America. Three members were directly affected by a pediatric eye condition and four were parents (one had dual experience). Additionally, three PAC members joined other Kids Eye Biobank governing committees. The PAC has held 14 virtual meetings. The original patient engagement plan was strengthened to focus initial efforts on member recruitment, mentorship, and enhancing the Kids Eye Biobank’s informed consent experience.

To enhance recruitment, the PAC contacted 11 cancer organizations, five Facebook groups and 30 Kids Eye Biobank participant families. To sensitize and train new members, the PAC created a “PAC Information Guide” and hosted a drop-in information session. PAC members identified the need for a patient-centered tool to facilitate informed consent discussions and have developed a prototype.

Conclusions: PAC member commitment is demonstrated by regular meetings, project progression, and involvement in Kids Eye Biobank’s governance and operations. Patient partners made unique contributions from their lived experience to suggest enhancements to the Kids Eye Biobank’s informed consent process. Future diversification of PAC membership promises to further maximize impactful patient contributions.

PF-05 Who Gets to Decide? Clinical Judgement vs. Gatekeeping in Biobank Participation

H. Dimaras^{1, 2}, K. Flegg¹

¹Ophthalmology & Vision Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, ²Ophthalmology & Vision Sciences, University of Toronto, Toronto, Ontario, Canada

Statement of Problem: Biobanking relies on obtaining informed consent from a diverse range of eligible patients. Ethical guidelines require that researcher introductions to patients be brokered by a member of their circle of care. However, this is often conflated with clinical judgment on whether the patient should be approached. This can be particularly challenging for time-sensitive research, where introductions occur in-person, often unscheduled near the time of diagnosis, heightening risk of gatekeeping that may unintentionally limit patient autonomy and research inclusivity.

Proposed Solution: We propose a novel framework that positions research as an essential component of the patient experience by formally embedding research team members into the clinical care pathway. Through coordinated introductions alongside clinical staff, patients are introduced to research opportunities as a valued aspect of their care journey, which is aligned with the mission of academic hospitals. This integrated approach removes the need for clinical staff to act as intermediaries, reducing demands on their time and removing the implication that they must evaluate the relevance of research introductions.

Conclusion: Reducing clinician gatekeeping in research participation respects patient autonomy and addresses logistical barriers to recruitment in high-demand clinical environments. Establishing direct, standardized pathways for introduction to research teams is essential to ensure patients have equitable opportunities to contribute to and benefit from medical research. Expanding this model could create a paradigm shift, enhancing the integration of research into patient care while protecting the ethical integrity of informed consent processes.

PF-06 Enhancing Decision-Making Capacity Assessment in Biobank Consent: A Proposed Role for Research Staff at the Kids Eye Biobank

K. Flegg¹, A. Hoffman¹, H. Dimaras^{1, 2}

¹Ophthalmology and Vision Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, ²Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada

Statement of the Problem: In Canada, individuals can consent to research at any age, provided they have decision making capacity. Decision making capacity refers to the ability to understand a research study and its associated risks and benefits. Research studies conducted in healthcare institutions often necessitate that a regulated health professional assess decision making capacity.

Biobank consent forms, used to convey research to prospective participants, have become increasingly complex. Biobanks routinely collect broad consent with optional components including return of results, for-profit research, genomic sequencing, and the creation of cell lines and pluripotent stem cells.

Located at The Hospital for Sick Children (Toronto, Ontario), the Kids Eye Biobank collects, stores and manages biological specimens, images and data relevant to vision and eye health. Ongoing assessment of decision-making capacity by regulated health professionals for the Kids Eye Biobank has been a challenge. Logistical constraints made it difficult for regulated health professionals to assess decision making capacity during standard of care appointments. Time constraints prevented regulated health professionals from adequately familiarizing themselves with the biobank consent form.

Proposed Solution: We propose that Kids Eye Biobank research staff assess decision making capacity of prospective participants. We adapted the Aid to Capacity Evaluation Tool (ACE), so that a standardized and objective determination of a decision-making capacity could be obtained. A training framework was also created to accompany the capacity evaluation tool. Training includes a theory-based module and practical training module with a regulated health professional.

Conclusion: Research staff plays an integral role in determining whether a potential participant has decision-making capacity. By shifting the responsibility for decision-making capacity assessments to research staff, we address the practical challenges faced by healthcare professionals and ensure that biobank consent can be efficiently and ethically obtained.

PF-07 Shaping Biobanks Together: The Power of Consumer Co-Design in e-Consent

A. Rudge², S. Higgins¹, S. Cauberg², W. Ng¹, S. Fox²

¹Cancer Council Victoria, Melbourne, Victoria, Australia, ²Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Background: Participant consent is a fundamental requirement for human biobanks, enabling ethical medical research. However, innovations in participant consenting vary globally, with biobank digitisation efforts often hindered by resource and cost restraints. Many studies continue to use manual (paper) methods, despite growing consumer-based literature favouring hybrid consenting models, incorporating online and paper capabilities resulting in increased flexibility. Australia has cultivated a strong national initiative to implement consumer co-design as a core element of research. Furthermore, patient digital literacy has increased in a world post COVID-19 pandemic, increasing healthcare consumer expectations. These shifts influenced Victorian Cancer Biobank (VCB), an Australian biobank consortium of 5 hospital-embedded biobanks and lead agency to transition to a co-designed electronic hybrid consenting model, investing in technical enhancements and engagement capabilities for ∼1,000 annual participants.

Methods: Through a structured project plan with embedded co-design principles, ongoing focused consumer meetings and collaboration with existing institution partnerships, VCB is implementing a consortium-wide electronic consent (e-Consent) workflow. Leveraging existing hospital capabilities, the VCB assembled a cohort of 6 consumers with diverse cultural, technological and geographical backgrounds and evenly distributed them to 3 User Acceptance Testing (UAT) workflow subgroups (phone call, video call and in-person/tablet). Structured interviews with Likert scale questions were used to collect feedback once testing concluded. All relevant privacy and ethical policies were adhered to.

Results: Embedding consumer co-design with UAT was effective to improve biobank consent workflows with appropriate consideration of participant perspectives, enabling an efficient, impactful rollout of digitized, streamlined consent capabilities.

UAT group’s responses indicated e-Consent capabilities:

- Simple to understand and complete.

- Increased participant flexibility.

- Increased opportunity for remote recruitment.

Conclusion: Consumer co-design is a value-add resource, efficiently enhancing biobanking consent workflows. By embedding consumer values and perspectives, improvements in consumer experience and potential effective integration of biobanking infrastructure with increasingly digital healthcare sector are seen.

PF-08 A Preliminary Analysis of Ethical Issues in Analyzing Public BioBank Data Using AIGC Technology

Y. Ji, T. Chen, H. Jiang

Huashan Institute of Medicine, Huashan Hospital Fudan University, Shanghai, Shanghai, China

Background: This study explored the ethical challenges by using Artificial Intelligence Generated Content (AIGC) technology to analyze the data from the public BioBank. Recently with the high technological developing, AIGC technology is gradually being applied into various research fields, even being used into the medical research. Public BioBank is an important resource for medical research, analysis the data from public BioBank by using AIGC technology will become very common. Whether the application of this new technology will change the traditional methods of data analysis and research, as well as a series of ethical challenges caused by the technology that cannot be ignored, are questions that deserve to be discussed by researchers around the world.

Methods: We analyzed AIGC technological potential in the processing of data at public BioBank, meanwhile we discussed the ethical issues will be faced, such as privacy, consenting, algorithm bias, responsibility, and transparency. These issues is not only being triggered from the technology itself, but also being caused by the limitations of current ethical standard. Because of above, we recommended to establish specialized ethical standards, for example, enhance algorithm transparency, strengthen data protection, or other methods to achieve a balance between the applications of technology and social welfare, and enhance the coordinated development of science and technology and ethics. In the details of our article, we will show the specific cases to reveal how we solved the problem caused by using AICG at ethical field.

Conclusion: From data privacy to social impact, the ethical issues faced by AIGC technology in analyzing data from public BioBank are multifaceted and complicated. By rethinking on these ethical issues, we realized that we need to continuously perfect our ethical standards with the scientific and technological progress, and this process itself will deepen considering at the relationship between technology and ethics.

PF-09 Material and Data Transfer Agreement Support or Obstacle in International Research and Collaboration

J. Kinkorova

Dept of Immunochemistry, University Hospital Pilsen, Pilsen, Czechia, Czechia

Statement of the Problem: Material and data from biobanks are the fundamentals for biomedical research. The main role of biobanks is to collect the material of the optimal quality and related data for current and future research purposes. The use of biobanking material and data is a fuel for research and innovation in health care, and for pharmaceutical industry, and others. To facilitate these processes, correct and precise MTA/DTA are necessary. MTA/DTA is a contract governing the transfer of materials between researchers. The researchers might be employees of universities, research institutions, biobanks, or commercial companies. MTA/DTA are necessary to sign to permit use of material, to obtain the access to research results, to have an appropriate recognition in any publication, to obtain a legal right to use these results and data, to receive a share of any revenues, to protect that the material/data are not being sold, to clarify other legal responsibilities: the risk of loss and damage.

Proposed Solution: The first step is to define: meaning of material, purpose for which the materials are provided, terms: time period, meanings of recipient and supplier; common restrictions: use only by specified persons, use only in a particular project, methods of transport, handling, delivery, charges of material, publications, confidentiality provisions. Then to open a wide discussion with all potential partners at national and international levels and start the process of harmonization. At the same time use the results and experience of “good practice” reached until now, and the European results from the international infrastructures operating in biobanks as, e.g., BBMRI-ERIC (Biobanking and Biomolecular Resource Research Infrastructure), that started this process at European level.

Conclusion: In the end MTA/DTA should facilitate the optimal use of material and data in biobanks. To find the optimal solution it is fundamental to accelerate reasonable use of material and data stored in biobanks worldwide and to accelerate the innovative processes in biomedical research and use of research results. The experience with the MTA/DTA harmonizing process in the European Research Area will be discussed as an example to present the success and the obstacles.

PF-10  

Hot Topics

PG-01 To Cull or How to Cull, Those Are the Questions!

M. Henderson¹, A. Black¹, K. Wyatt²

¹Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, United States, ²Cancer Genomics Research Laboratory, Leidos Biomedical Research, Inc., Rockville, Maryland, United States

Statement of the Problem: Biorepositories around the world are storing specimens that have minimal or no utilization, based on our 2017 global survey of biobanks, that was published in Biopreservation and Biobanking (https://doi.org/10.1089/bio.2018.0079). Our US government population-based research biorepository contains over 15M specimens from over 400 global cancer research projects conducted by investigators in the Division of Cancer Epidemiology and Genetics, NCI. Our collections date from the early 1960s, with most of the collection accruals from the 1990s and beyond. With such a vast and large set of collections, the need for space to store NCI’s newest accruing US-population cohort, CONNECT, and tightening of federal budgets, we have been motivated to accelerate the detailed evaluation of our biorepository collections.

Proposed Solution: Our biospecimen resource team took the initiative to understand the use of our collections in the past, currently and any future plans, to ascertain if there were any collections for which our scientists had little future utilization plans. Part of the efforts included an internal review of the sample types, consent restrictions, quality, and associated data availability. The thorough review and important decisions to keep, transfer, or destroy collections and/or a selected subset of specimens were made by the investigators, reviewed by their branch leadership, our team, and recommended to our Division leadership before proceeding.

Conclusions: This presentation will describe our process of trimming down our collections, creation of tools to support our careful review and the interim results of our ongoing efforts to cull our collections through smart operational review. We believe our lessons learned through this process could be easily transferrable to other biorepository operations globally.

PG-02 Decentralized Biobanking to Empower Patient Engagement in Organoid Research

A. Dewan¹, E. Budd⁴, M. Eifler⁷, W. Sanchez⁶, J. Kahn⁵, R. C. Miller³, M. Macis², M. Gross^{5, 6}

¹Johns Hopkins Medicine, Baltimore, Maryland, United States, ²Carey Business School, Johns Hopkins University, Baltimore, Maryland, United States, ³Mayo Clinic College of Medicine and Science, Rochester, Minnesota, United States, ⁴Binghamton University, Binghamton, New York, United States, ⁵Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, United States, ⁶de-bi, co., Baltimore, Maryland, United States, ⁷BlinkPopShift, San Francisco, California, United States

Background: Organoids are living, patient-derived tumor models revolutionizing precision medicine and drug development. However, current privacy practices that strip patient identifiers undermine ethics and effectiveness for patients and research. Decentralized biobanking is a novel approach leveraging non-fungible tokens (NFTs). It empowers patients to remain engaged with organoids derived from their specimens and collaborate with scientists and physicians in a privacy-preserving network. We explore patient perspectives and pilot a decentralized biobanking application for breast cancer organoids.

Methods: From 2021-2023, we surveyed and interviewed breast cancer patients in a large US academic institution’s biobank. Organoids were described as “living 3D copies” of donated tumors/tissues, supplemented with visuals. Questions assessed perspectives on organoid significance and preferences for tracking, viewing, and commercializing organoids derived from their tissues. Using ERC-721 and ERC-1155 NFT protocols, web, and Flutter mobile app, prototypes of the decentralized biobanking platform were developed, featuring organoids from the local breast cancer biobank and Human Cancer Models Initiative. Prototypes were tested in participatory design surveys, workshops, and a live pilot.

Results: Of surveyed patients, 69% wanted to know if their cells were immortalized. Most wanted to be notified if researchers/companies outside the academic institution sought to use their organoids. Most surveyed patients (76%) were interested in viewing their organoid images; however, preferences varied on image sharing. Advanced-stage cancer patients expressed that knowing their immortalized cell lines could aid other patients and advance cancer research beyond their lifetime provided a sense of purpose and reassurance. We further review our series of patient-centered organoid platform prototypes, describe how it was designed as a citizen science network for personalized research communities, and discuss deployment for a subset of locally-sourced patient-derived organoids accessible to the biobank donor population.

Conclusions: Patients valued tracking organoids, appreciated their visually captivating images, and were enthusiastic about decentralized biobanking’s potential to unlock transparency, dignity, and engagement. Next steps must address precision medicine opportunities, ethical considerations, and scalable technologies for a biomedical metaverse.

PG-03 Biobanking in the ASEAN Region: Challenges and Opportunities

D. L. Garcia⁴, Z. Kozlakidis¹, I. Cheong², P. B. Medina³

¹International Agency for Research on Cancer, Lyon, Rhône-Alpes, France, ²Shanghai Jiao Tong University, Shanghai, China, ³Research Institute for Tropical Medicine, Muntinlupa City, Philippines, ⁴Independent Consultant, San Francisco, California, United States

Statement of the Problem: Biobanking in the ASEAN region has been gaining momentum as countries focus on developing infrastructure to support personalized medicine, genomics, and public health research. Countries such as Singapore, Malaysia, Indonesia, and Thailand are leading the way in biobank development, establishing centralized biorepositories that facilitate research collaborations across the region. Therefore, ASEAN-based biobanks have the potential to play a critical role in studying genetic diversity, which is essential for understanding disease prevalence and developing treatments tailored to the region’s unique populations. However, the growth of biobanking in ASEAN faces challenges, including the need for standardized ethical guidelines, data sharing protocols, and funding support.

Proposed Solution: An ambitious program, led by the Research Institute for Tropical Medicine, Philippines, has been created and has been active since 2019, aiming to understand the development of biobanking in the ASEAN member states, to conduct feasibility studies where appropriate and possible, and to generate educational and training material that would be customised to the needs of the region.

Conclusions: This poster will summarise the findings of the work conducted thus far, and will highlight three planned engagements for the following years. As ASEAN biobanks continue to expand, they are likely to foster greater research innovation, improve healthcare outcomes, and contribute significantly to global biomedical research initiatives.

PG-05 Standardized Construction of Experimental Cell Bank of Rare and Complex Diseases in Peking Union Medical College Hospital of China

H. Zhu, S. Zhang, Y. Yang, X. Wang, F. Li, K. Zhao, A. Wang, D. Guo

Clinical Biobank, Peking Union Medical College Hospital, Beijing, Beijing, China

Background: Rare and complex diseases are a category of illnesses characterized by rare individuals, diverse types and severe symptoms, and their diagnosis presents diagnostic and therapeutic challenges. The standardized construction of rare diseases cell repository and information management system will provide qualified samples for scientific research, drug discovery, diagnosis and treatment.

Methods: Blood samples were collected from clinically diagnosed patients and families, and peripheral blood mononuclear cells (PBMCs) were isolated. To establish immortal lymphoblastoid cell lines (LCLs) by EBV transformation from PBMCs, mycoplasma contamination was detected by PCR and the marker CD19 was detected by flow cytometry. Cell genetics were determined by karyotype analysis, and cell stability and viability were assessed by AO/PI staining and culture. Induced pluripotent stem cells (iPSCs) were derived from cultured PBMCs, into which reprogramming factors were introduced via the non-integrated virus vector. The pluripotency of iPSCs was detected by immunofluorescence staining, flow cytometry, and qPCR. The differentiation potential of iPSCs was assessed by subcutaneous teratoma formation in nude mice or in vitro three-germ layer differentiation. The identity of iPSCs was verified and compared with parental cells by STR site analysis. Additionally, the karyotype during reprogramming was detected by chromosome karyotype analysis.

Results: Forty-four LCLs and 13 iPSCs were successfully established from dilated myocardium, left ventricular noncompaction, hypertrophic myocardium, transthyretin amyloidosis, limb-girdle muscular dystrophy R2, thrombotic microangiopathy, primary biliary cirrhosis, and hypotrichosis-lymphedema-telangiectasia syndrome. Furthermore, the standardization of process and information management system for LCLs and iPSCs banks of rare and complex diseases were also accomplished.

Conclusion: The processes pertaining to LCLs and iPSCs were satisfactorily adapted in the establishment of the cell line panel. The cell model of LCLs and iPSCs from rare diseases could provide a samples resource for studies related to potential new pathogenic genes or mutation sites. In addition, this study laid the foundation for further research into the pathogenesis and therapy of diseases.

PG-06 An Organoid Platform for Ovarian Clear Cell Carcinoma

Y. Chen, S. Zhang, J. He, Y. Wang, Y. Gao, Y. Zhang, A. Wang, K. Zhao, Z. Zhang, Y. Yang, J. Sun, D. Guo

Peking Union Medical College Hospital, Beijing, Beijing, China

Background: Ovarian clear cell carcinoma (OCCC) is a subtype of ovarian cancer, it is considered a rare tumor type, ranking second in incidence among the various histological subtypes of ovarian cancer. However, patients with advanced OCCC have a poorer prognosis compared to other histological subtypes of ovarian cancer and exhibit resistance to conventional therapies, making clinical diagnosis and treatment particularly challenging. Therefore, developing relevant preclinical models to identify new therapeutic strategies is crucial. Organoid models have emerged as important tools for simulating human physiology and diseases. Currently, there have been no reports on the establishment of relevant organoid repositories. Thus, this study aims to establish an OCCC organoid research platform and explore its applications in drug testing and personalized medicine.

Methods: In this study, OCCC organoids were generated from patient tumor samples and cultured using 3D culture system. To compare the organoids with their corresponding tumor tissues, we performed hematoxylin and eosin staining and evaluated the expression of biomarkers, such as paired box gene 8. Next, we conducted whole exome sequencing analysis to compare somatic mutations, driver gene mutations (such as ARID1A), tumor susceptibility gene mutations (such as MSH2), and frequently mutated genes (such as PIK3CA). To date, we have successfully established 10 cases of OCCC organoids and developed a comprehensive management system to support this research.

Results: The results demonstrated that the established OCCC organoids retained the histopathological features and genetic signatures of the parental tumors. We will investigate and identify specific drug sensitivities and resistance mechanisms to guide treatment strategies for individual patients.

Conclusions: In conclusion, the successful establishment of OCCC organoids provides a valuable platform for studying the biology of ovarian clear cell carcinoma and offers promising avenues for personalized therapeutic approaches. The ability to model tumor heterogeneity and drug responses in vitro may significantly enhance our understanding of OCCC and improve treatment outcomes. Future studies will focus on integrating these organoid models with high-throughput screening technologies to identify novel therapeutic targets and optimize treatment regimens for patients with OCCC.

PG-07 Intelligent Development of Biobank Enables Scientific Research Transformation

A. Wang, F. Li, K. Zhao, Z. Zhang, Y. Yang, D. Guo

Peking Union Medical College Hospital, Beijing, Beijing, China

Background: With the rapid application of artificial intelligence (AI) technology, the automated and intelligent biospecimen repository is moving from a single storage device automation to the deep integration of automation applied to the whole process. Peking Union Medical College Hospital (PUMCH) biobank has been established for 12 years as a hospital-level comprehensive biobank, and it has begun to see results in the intelligent and automated operation and management of the whole process of biospecimen and information data.

Methods: After more than a decade of development, PUMCH biobank has established three major species banks for humans, animals, and microorganisms. The standardized biobanking activities of clinical biospecimen have achieved internationally advanced levels. We use AI technology to accurately determine informed consent signing compliance during biospecimen receipt and preparation. The biobank is equipped with a pneumatic transfer device to automatically transfer samples from operating theatres and wards to the receiving area in an efficient and time-saving manner throughout the hospital. We have an automated pipetting workstation for pathological tissue sample processing; meanwhile, we are equipped with an automated dehydrator that can process 300 formalin tissue samples in 14 hours. Depending on research needs, we have fully automated tissue microarrays with up to 588 cores in a single run. The merscope spatial transcription system enables in situ sub-single cell spatial transcriptomics analysis for gene visualisation. The biobank leverages China’s independent technologies to build automated and intelligent storage platforms for ambient, low, ultra-low, and deep low temperatures storage, with a total storage capacity exceeding 10 million aliquots. The biobank integrates information technology with automated equipment, achieving high-quality, high-efficiency, and high-precision biospecimen management.

Results: By using the automated and intelligent equipment resources, we can improve sample quality and data integrity, promote synergistic development of multiple hospital districts, and ultimately, in the research of rare diseases, the biobank can rapidly carry out clinical basic and translational research.

Conclusions: The intelligent development of biobank provides strong support for scientific research transformation and comprehensively empowers hospitals’ research management.

Informatics & Technology

PH-01 Experience in Building a Biobank CDM Linked with EMR-Based CDW

E. Kim^{1, 2}, S. Song³, J. Kim⁴

¹Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ²Inje Biobank, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ³Indang Biomedical Research Institute, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ⁴Pukyong National University, Busan, Busan, Korea (the Republic of)

Background: Inje Biobank, one of the Korea Biobank Network (KBN) members, collects clinical data along with biospecimens from participants. Biobanks around the world have been trying to build health databases linked with hospital electronic medical records (EMRs) so that they can be used along with biospecimens for biomedical research. KBN established KBN common data model (CDM) for data standardization of which KBN member biobanks load their data by the CDM format. Our biobank also recognized the need to establish a biobank CDM linked with our hospital EMR-based clinical data warehouse (CDW), which can load data to KBN CDM.

Methods: Personal information contained in EMR must be de-identified to build a CDW according to our hospital policy. To solve this, a de-identification solution software was introduced. In order to avoid the impact on the operating system, the backup database of our EMR was set as the data source. Only the data processed through the de-identification solution was transferred to the CDW database. Methods used for de-identification include format-preserving encryption, deletion, etc., depending on the data characteristics. Our biobank CDM was created based on the KBN CDM format to load data efficiently.

Results: A text-based CDW (Busan paik Archive for medical Data, BADA) was established based on our EMR. In the constructed CDW, BADA, data are automatically de-identified and transferred every month based on scheduling, and this includes about 200 tables containing key data such as patient information, medical recording, prescriptions, and test results. A biobank CDM based on KBN CDM format was constructed using BADA to link KBN CDM and additional research is being conducted to convert BADA to some CDMs which will be able to be used in various studies in the future. BADA has the same source and target database structure of our EMR, making it difficult for general researchers to use as it requires understanding the database to extract data directly. To complement this, we have additionally developed a dashboard to provide researchers with information about current data characteristics of BADA.

Conclusions: Using the created CDW, BADA, based on our EMR, an efficient biobank CDM was built, which can be linked to the KBN CDM. In the era of big data, the constructed system can be contribute to future biomedical research by further development.

PH-02 Automated Screening for Study Eligibility: Increasing Recruitment and Optimizing Biobank Workflow

C. O. Familusi, S. S. Fox, C. C. Valente, C. B. Schleicher, J. M. Crawford, Y. C. Ziemba

Department of Pathology and Laboratory Medicine, Northwell Health, New Hyde Park, New York, United States

Background: Efficient patient screening is central for biobanking operations, especially when managing multiple studies with sophisticated eligibility criteria. We developed a solution that integrates appointment scheduling data and electronic health record data with inclusion criteria to automate eligibility screening across more than 15 concurrent studies. The streamlined workflow then uses dashboarding to flag proposed patients with research staff, who then confirm eligibility.

Methods: Our pipeline gathers data from an enterprise scheduling system, the inpatient electronic health records (EHR) and the outpatient EHR. The computer scripts model eligibility criteria based on ICD codes, chemotherapy history, and natural language screening of pathology and radiology reports. The automated screening rules examine the coming three weeks of scheduled surgeries; eligible candidates are displayed on a Power BI dashboard, updated twice daily. The dashboard provides key details including proposed study name, patient identifiers, contact information, and preferred language. Research coordinators then manually confirm eligibility based on the dashboard’s output, and contact patients to assess interest in study participation.

Results: Before implementation, an average of 435 patients per day required manual triage. Following implementation, manual confirmatory screening averaged 78 per day, representing an 82% volume reduction. Similarly, prior to automation, five research coordinators spent 8-12 hours per week reviewing a single day on the week’s schedule. Post-implementation, this has been reduced to just 1-3 hours per week, achieving approximately 80% time savings. This equates to 217 work hours saved per month. Within a year of implementation, the monthly number of patients approached increased by 51%, consented patients increased by 57%, and the patient consent rate increased from 72% to 76%.

Conclusions: This centralized, streamlined approach saves research coordinators valuable time, boosts recruitment volumes and success rates for patient consent, and significantly reduces the chance of missing eligible patients. While effective, there are limitations, particularly regarding the reliance on radiological interpretations to ensure that the tumor size threshold is met, as imaging may not always accurately reflect actual tumor size. Future enhancements will focus on incorporating advanced analytics and machine learning to further increase identification accuracy and reduce coordinator time.

PH-03 The Peripheral Blood Mononuclear Cell (PBMC) Isolation Automation Experience: The Benefits and Challenges of Transitioning Workflows

M. Villalva, Y. Li, S. Macphail, B. Caruana

NSW Health Statewide Biobank, Camperdown, New South Wales, Australia

Background: Peripheral blood mononuclear cell (PBMC) isolation is a key service that is requested at the NSW Health Statewide Biobank (NSWHSB), with the demand exponentially increasing over the last two years. Our initial PBMC isolation method, based on manual density gradient centrifugation, became a bottleneck in meeting this growing demand. To address this, we explored a magnetic bead-based PBMC isolation method compatible with automation, aiming to enhance throughput and consistency. To validate this new method in line with our ISO-9001 certification, we compared the new and existing methods and reported that cell viability and the proportion of cell types were comparable, with the added advantage of significantly reduced red blood cell, granulocyte, and neutrophil contamination¹.

Results: Implementation of the bead-based automated method allowed us to increase daily PBMC processing per technician. The upgraded workflow, supported by three automated PBMC isolation units, now enables the processing of up to 12 samples within 30 minutes with minimal hands-on time required per technician. This shift not only provides consistency and precision in sample processing but also helps reduce staff fatigue—an increasingly crucial benefit as our team manages up to 60 PBMC samples daily.

Conclusion: In this presentation, we expand on our findings published in the Journal of Visualized Experiments¹ by sharing our experience transitioning to the automated workflow. We discuss the benefits and challenges of this transition, reflecting on insights gained from processing over 6,000 PBMC samples in the last 18 months, and prepare this PBMC isolation service for accreditation under ISO-20387.

Reference

(1) Villalva M, Macphail S, Li Y, Caruana B. Isolating Human Peripheral Blood Mononuclear Cells from Buffy Coats via High Throughput Immunomagnetic Bead Separation. Journal of Visualized Experiments (JoVE). 2024 Jul 19(209):e66887.

PH-04 Development and Configuration of a BIMS for Data-Driven Microbial Collections

O. A. Mantilla, E. Muhle, D. Clermont, M. L. Ferrari, O. Chesneau, M. Gugger, D. Garcia Hermoso, L. Debarbieux, J. Vanhoutte, F. Betsou

Biological Resource Center of Institut Pasteur (CRBIP), Institut Pasteur, Université Paris Cite, Paris, Paris, France

Statement of the Problem: Microbial collections are a strategic tool for research and development across various industries. However, there are hardly any biological information management systems (BIMS) that meet modern data management standards and that are adapted to microbial collection specificities. The Biological Resource Center of Institut Pasteur (CRBIP) administers more than 200,000 samples related to more than 8,300 different species of bacteria, fungi, and cyanobacteria, gathered over more than 100 years. These samples undergo microbiological preparation methods and various analyses to improve strain characterization. The home-made legacy BIMS lacked the flexibility needed to manage diverse types of samples and characterization data, including genomic, phenotypic, and taxonomic information. It often stored different types of information within the same data fields, leading to redundancy, which made it challenging to maintain comprehensive, organized, and accessible records that could be updated promptly and presented effectively to end users.

Proposed Solution: To remain relevant and support the growing demands of scientific and industrial research, the CRBIP has transitioned to a data-driven management model by implementing new data storage and analysis technology. For this, we have worked with the supplier of a commercial BIMS (MBIOLIMS) to develop, configure, and validate a novel instance adapted to the specific requirements of microbial strain samples. This system enables the creation of data fields under specific modules designated for the different stages of the life cycle of a sample in the biobank. Additionally, the system allows dynamic communication with other databases to maintain updated taxonomic information, while integrating with systems involved in sample distribution, such as SAP. This facilitates seamless tracking from accession to distribution.

Conclusions: This shift to a data-driven management model is vital for improving operational efficiency and ensuring compliance to ISO 20387 and ISO 21710, which demand strict data integrity, traceability, and reliability. By enhancing the organization of data, the system gives end users more confidence in the microbiological materials. Moreover, it ensures that data are structured in a way that promotes better understanding and is readily accessible for advanced data analysis, ultimately supporting more informed decision-making.

PH-05 GTEx Resources: Still Empowering Biomedical Research after 10 Years

P. Guan, A. Rao, H. Moore

National Cancer Institute, Bethesda, Maryland, United States

Statement of the Problem: Big data in health research can enable revolutionary breakthroughs in understanding diseases and their treatment. However, access to datasets such as comprehensive clinical data abstracted from electronic health records, medical imaging, and genomic sequencing, and using data cohesively across many disciplines, has been a major challenge to the successful use of big data.

The NIH Common Fund’s Genotype-Tissue Expression (GTEx) Project established a data resource and tissue bank to study the relationship between genetic variants and gene expression in multiple human tissues and across individuals. By 2015 GTEx had generated, from a cohort of ∼1000 healthy individuals, a large volume of data including clinical and histopathological data as well as genotyping and gene expression data from whole genome sequencing, whole exome sequencing, expression array, and RNAseq.

Proposed Solutions: GTEx generated valuable biospecimen and data resources that continue to support biomedical research. A unique public ID assigned to each GTEx donor links all data collected and generated from that donor. The resources [HM1] are available at the following public websites:

1)

GTEx Portal: an open access database of GTEx expression data and analysis Results: http://www.gtexportal.org

2)

Database of Genotypes and Phenotypes (dbGaP): controlled access of comprehensive GTEx clinical data and raw sequencing data: https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000424

3)

Access to residual GTEx biospecimens for research: http://www.gtexportal.org/home/samplesPage

4)

SOPs and best practices from GTEx biospecimen collections: http://biospecimens.cancer.gov/resources/sops/library.asp

5)

GTEx histological image viewer: http://biospecimens.cancer.gov/resources/tissue_image_library.asp

6)

NEW open access to digital histopathology images in DICOM format at NCI’s Imaging Data Commons: https://portal.imaging.datacommons.cancer.gov/explore/filters/?collection_id=gtex

Conclusions: GTEx data have been used in combination with other data sets such as The Cancer Genome Atlas and genome-wide association studies to further explore the genetic causes and biology of cancer. More than 2000 research articles have been published in multidisciplinary fields using GTEx data over the years. New data are being generated from the GTEx legacy biospecimens, available through a transparent access policy.

PH-06 Can Biobanks Be the Solid Bridges between Pediatric Oncology Prognostics and Machine Learning: Results from a Comprehensive Meta-Analysis

P. Varga^{1, 2}, M. Obeidat¹, T. Kói¹, S. Kiss-Dala¹, E. Tuboly^{3, 1}

¹Centre for Translational Medicine, Semmelweis Egyetem, Budapest, Budapest, Hungary, ²Heim Pal Gyermekkorhaz, Budapest, Budapest, Hungary, ³Hungarian Pediatric Oncology Network, Budapest, Hungary

Background: Current pediatric cancer care requires innovative approaches to predict prognosis that facilitates personalized stratification. Building modern, trustworthy prediction models demands large, diverse, and quality-assured databases, which can be provided best by biobanks. However, the scarcity of pediatric cohorts limits the availability of data necessary to establish biobanks in this field. To demonstrate the rapid development of model construction, we reviewed the literature and meta-analyzed the available data on the effectiveness of prediction models.

Methods: A systematic search was conducted in four databases on 28 June 2024. Studies on the accuracy of prognostic markers or models used in pediatric hematological malignancies, central nervous system (CNS), or non-CNS solid tumors (NCNSST) were included. Three model categories were defined using: 1-clinical, 2-genomic-transcriptomic, and 3-machine learning (ML). Primary outcomes were area under the receiver operating characteristic curve with a 95% confidence interval (CI) for various overall (OS) and event-free survival. Additional analyses were done focusing on the databases used, with emphasis on whether the validation was done on the same or a different dataset as the training set (external (EXV) or internal validation (INV)).

Results: Of 12,982 studies, 385 were included in our study, with limited data on ML-approaches. Our main outcome was non-time dependent OS prediction in NCNSST patients, where a statistically significant difference was observed between Category-3 (0.85 [CI: 0.83−0.87]) and Category-2 (0.78 [CI: 0.73−0.83]) (p=0.035), and Category-1 (p=0.14) (0.76 [CI: 0.71−0.81]). INV studies showed significantly better performance compared to those using EXV, highlighting the high risk of bias inherent in INV and the demand for structured quality-assured data collection and sharing, to facilitate EXV.

Conclusion: This study represents the most comprehensive meta-analysis to date on prognosis prediction in pediatric oncology. Although the current literature on ML methods in prognostics remains limited and reliant on a small number of high-quality public datasets, our findings demonstrate the potential superiority of ML approaches in this field. Expanding pediatric biobanks and data repositories, along with harmonizing existing resources, will provide ML research teams with the quality-assured data needed to advance prognostic models in pediatric oncology.

PH-08 Robosep-S: Pioneering Automated Mononuclear Cell Processing for Optimized Acute Leukemia Biobanking

K. Czibere¹, O. Bigun¹, A. Misura¹, N. Kundu¹, S. Chow^{1, 3}, H. Tsui^{1, 2}

¹Biobank, Laboratory Medicine and Molecular Diagnostics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, ²Division of Hematological Pathology, Precision Diagnostics and Therapeutics Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, ³Hematology Site Group, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Background: The Sunnybrook Hematology Biobank, part of the Laboratory Medicine and Molecular Diagnostics department at Sunnybrook Health Sciences Centre, viably cryopreserved 62 acute leukemia (AL) specimens in 2023. Mononuclear cells (MC) were manually processed from peripheral blood (PB) and bone marrow aspirates (BMA) using density gradient centrifugation (DGC). Previously validated for non-malignant MC isolation, the RoboSep-S, opens a potential to optimize biobanking workflow capacity using an automated cell separation system. Ultimately, we explore the feasibility of transitioning over to automated AL processing.

Methods: Complementary to daily biobanking activity, clinical surplus PB/BMA from patients with AL/AL-equivalents (blasts ≥20%) were requested from triaging hematopathologists. Specimens were processed and cryopreserved on RoboSep-S following StemCell Technologies protocols, and total yields were compared against paired specimens post DGC, normalized for specimen volume. Total MC yield, recovery, and capture rates were evaluated using the Cell-Dyn Emerald hematology analyzer. MC recovery was assessed via the % difference between expected and observed MC counts. Capture rate was calculated using (observed/expected) MC counts × 100. Giemsa-stained cytospins were analyzed with a light microscope, and differential counts were compared to the original specimen slides.

Results: Fifteen total cases were processed (5:10, PB:BMA). MC yield comparisons were performed in 10/15 cases (2:8, PB:BMA). PB cases had a maximum of 5% difference between yields, whereas BMA cases varied: 5 were 8-20% and 3 were 107-170%. The difference between PB and BMA recovery rates ranged from 7.7-50% and 13-180%, while the capture rates were 59-108% and 18-153%, respectively. Ten of 15 cases presented a capture rate >70%, but notably, 3/15 cases had <34%. Differential counts were compared from 11 cases (7:4, BMA:PB). For PB cases, the blast increased up to 63%. While 6/7 BMA cases showed an increase up to 41%, 1 case had 23% reduction.

Conclusion: PB specimens with hematological malignancies show great promise for automated processing. Further investigation with a larger sample size of all AL subtypes should be completed for both PB and BMA to evaluate possible correlations between diagnosis and MC isolation kit compatibility. Flow cytometry analysis on thawed DGC and RoboSep-S MC will also aid in comparing cell populations to gauge which method is superior for biobanking practices.

PH-09 Approaches for Data Surety in Biorepository Inventory Management Systems

R. Jochim, K. Gajewski, B. Nenbee

Merrick and Company, North Chesterfield, Virginia, United States

Problem: An inventory management system (IMS) is a fundamental component of a biorepository’s data management plan. As a biorepository expands and data volume increases, maintaining data integrity is instrumental in ensuring successful operations. Processes can introduce errors in inventory data when updating standardized nomenclature, bulk updates to information or when transferring sample information. The implications of these errors are a compromised inventory which may lead to incorrect sample acquisition, mismanagement of patient data, and potentially compromised research studies. These errors jeopardize the integrity of samples, the biorepository, associated research laboratories, and potentially may result in regulatory compliance issues. To mitigate such risks, biorepository quality management plans (QMP) must integrate routine quality assurance practices, such as data reconciliation processes.

Proposed Solution: A robust reconciliation process is a critical component of a biorepository QMP. Effective data reconciliation includes a comprehendible workflow, detailed timeline for routine quality checks, and records of reconciliation-initiating events. Initiating events, beyond routine quality checks, should be categorized based on the potential risk of integrating errors into the biorepository inventory. While reconciliation measures can be routine and labor intensive, advanced software tools can be utilized to quickly process large quantities of data for common errors such as missing information, invalid entries, duplicated information, and non-standardized values. Database management software can serve as a standardization tool for data exports and imports, ensuring data integrity. The software is used to generate indicator variables, further expediating large-volume data reconciliation efforts. Additionally, coding platforms can be used to rapidly identify data fields in need of corrective action. These adjustable software tools can be used for micro and macro data monitoring of dynamic repository data.

Conclusions: The biorepository IMS is a complex records system that requires comprehensive data quality assurance measures. Integrating the accessible database management tools of software and coding platforms in a data reconciliation process within a QMP will maintain data integrity and reliability. By establishing accurate sample information, these tools support successful biorepository operations.

PH-10 Making a Greener Consent Model

A. MacArthur, D. Naeh, L. Spary, A. Parry-Jones, R. Clarkson, R. Adams

Wales Cancer Biobank, Cardiff University, Cardiff, Wales, United Kingdom

Background: The informed consent process is a fundamental ethical and legal requirement in research where individuals are asked to participate in activities that may affect their health, well-being, or personal rights. The process ensures that individuals have sufficient information to make an autonomous, informed decision about whether to participate in a specific procedure, study, or treatment. Traditionally, Wales Cancer Biobank (WCB) used paper-based consent forms, leading to high costs and a large carbon footprint. A more sustainable, digital consent model could reduce paper use and improve operational efficiency.

Methods: An electronic consent (eConsent) app was developed to facilitate the informed consent process. The app allows staff to create clinic lists, introduce the Biobank to patients, present animated videos, take patients through the consent process, and capture a digital signature. Once a consent has been recorded the app transfers the patient consent, through a secure information transfer platform, to the biobank’s electronic database. A biometric sign-in ID is used to protect the app registration and configuration area from unauthorised access.

Results: Since the launch of the programme in April 2023, Biobank staff have consented a total of 604 patients. Of these consents, 234 were taken using the eConsent module (39%) and this has risen to 42% by April 2024. Both users and patients have found the programme to be easy to use and navigate. Patients are especially supportive of the option to receive their copy of the consent form in either digital or paper format, with digital proving very popular. Biobank staff report positively in relation to the time- and resource-saving capability to pre-load patient information, and the direct server link to the WCB database, making subsequent manual consent registration unnecessary.

Conclusions: The eConsent module has proven that the Biobank’s patient demographic are capable and supportive of using digital technology to both inform and confirm patient consent for research. The programme itself allows for a greener, paper-saving method of recording consent; and Biobank users have been given back the valuable resource of time by utilizing the automated functionality of parts of the module. It is imperative that connectivity issues are addressed in advance of rolling out this programme into different clinic environment—ensuring a smooth transition from paper to digital consent.

PH-11 Design and Application of a Data Management Solution for a Hospital-Based Research Biobank

T. Franchin, G. Di Giovamberardino, V. Marcellini, A. Sammarco

Scientific Institute for Research Hospitalization and Health Care, Children’s Hospital Bambino Gesù, Rome, RM, Italy

Background: Biobanks should assure data quality from the beginning of the process and provide a quick and structured recovery of data, by having IT solutions to query and aggregate them, and to properly maintain and update metadata. Data quality assessment is an iterative process, which includes evaluation of how effectively data represents the objects, events, and concepts it is designed to represent. Data quality assessment is an iterative process, which: includes evaluation of how effectively data represents the objects, events, and concepts it is designed to represent, and presumes the measurement of data quality is carried out by well-defined quality dimensions and meets the assumption of the fitness for purpose. The amount of available biospecimen data has increased significantly due to recent advances in technologies (i.e., “-omics” one) and the use of them is not often known in advance; for this reason, it is crucial to assure a good quality of meta-data and meta-metadata to recognize the more suitable dataset for a specific require.

Methods and Conclusion: In this poster, we share our experience in achieving the objective of developing an IT solution of a data management system for a hospital-based research biobank, for a large volume of structured, semi-structured, and unstructured data, in its native format and located in different research and clinical archives, in order to query several repositories simultaneously and to generate a custom typed-dataset without moving and duplicating data; the availability of a solution for automating data transfer to patient registries, to improve and streamline sample and FAIR data access process. This was possible through the acquisition and integration of HPE infrastructure systems and the design and application of hospital data lake system based on products for the development of ETL procedures, the storing of semi-structured or unstructured data, and the data analytics.

PH-12 Optimizing Information System Operations for Large-Scale Biobank and Resource Management in Korea

M. Chu, D. Kim, J. Jung

National Biobank of Korea, Korea Disease Control and Prevention Agency, Cheongju-si, Chungcheongbuk-do, Korea (the Republic of)

Background: The Human BioBank Information System (HuBIS), utilized across 70 biobanks in Korea, serves as a critical platform by managing datasets and ensuring operational accessibility. However, the demand to handle biospecimens from one million participants, coupled with advancements in technology and evolving user requirements, has exposed limitations in scalability, performance, and integration. These challenges necessitate a system overhaul to enhance efficiency and adaptability.

Methods: A systematic review of HuBIS identified key areas requiring improvement, including system performance and data management. Bottlenecks such as outdated infrastructure and insufficient processing capacity were prioritized. Proposed interventions included automated resource intake processing, distributed pre-processing logic to ensure performance, real-time inter-system connectivity, and restructuring of data workflows.

Results: The upgraded HuBIS, equipped with distributed pre-processing logic for biospecimen intake, demonstrated the ability to accommodate an 18-fold increase in daily data intake through software-only modifications, effectively managing up to 18 million new biospecimens annually. Automation reduced manual handling times by 40%, while improved architecture and cloud integration boosted data processing speeds by over 50%. These enhancements ensured robust data security and compliance with national regulations.

Conclusion: The optimized HuBIS highlights the value of in-house development in delivering a high-performance biobank management system. By addressing legacy limitations and adapting to large-scale requirements, HuBIS provides a sustainable solution for managing biospecimens at a mega biobank level. These advancements highlight the importance of timely upgrades and efficient resource management in supporting large-scale biomedical research.

PH-13 Universal Consent Registry: A Model for Simplifying Research Participation and Accessing Diverse Biospecimens

L. Solis¹, A. Davis², S. Hussain³, N. Anderson¹

¹Clinical and Translational Science Center, University of California Davis, Sacramento, California, United States, ²EMR Research Applications, University of California Davis, Sacramento, California, United States, ³Comprehensive Cancer Center, University of California Davis, Sacramento, California, United States

Background: The Universal Consent Registry (UCR) is an innovative framework designed to streamline research participation and ethically use de-identified remnant clinical samples and data. By obtaining general consent through existing hospital infrastructure, the UCR minimizes administrative barriers and ensures compliance with regulatory standards. This approach expands researchers’ access to diverse, representative biospecimens and associated clinical data, supporting cutting-edge research in personalized medicine and population health.

Methods: The UCR uses a patient-centric, electronic consent process integrated into the Epic electronic medical record. Patients receive educational materials, including a video and frequently asked questions, during MyChart eCheck-In or clinical visits. Consent is documented electronically, and daily reports from the Data Center of Excellence identify remnant biospecimens from consented participants. This process ensures HIPAA compliance and institutional policy adherence while linking de-identified lab samples and data to participants.

Results: In the first six months of UCR activation, over 4000 patients were invited, with 66% providing consent. This enables the potential collection of more than 1000 remnant biospecimens per month without added costs or risks to patients or insurance providers. The Registry has established a reliable infrastructure to identify, separate, and de-identify eligible biospecimens for research use. Preliminary findings suggest the UCR accelerates project initiation and improves diversity in research participation.

Conclusions: The UCR represents a scalable model for modernizing remnant biospecimen collection and democratizing research participation. By integrating consent into routine healthcare interactions, the UCR ensures compliance with National Institutes of Health guidelines mandating patient consent for using de-identified samples and data. This transparent, ethical approach overcomes traditional challenges in biospecimen access while fostering public trust. Future efforts will expand the registry to include pediatric and neonate populations, optimize workflows, and assess long-term impacts on research outcomes.

PH-14 Imaging Data in the Cancer Moonshot^SM Biobank

V. Gopalakrishnan¹, A. Mohandas³, J. McClean³, M. Jensen³, P. Guan¹, S. McDermott³, H. Ellis², A. Rao¹, L. Agrawal¹, B. Fevrier-Sullivan³, J. Freymann³, C. Karlovich³, H. M. Moore¹

¹National Cancer Institute, Bethesda, Maryland, United States, ²Biobanking Without Borders LLC, Durham, North Carolina, United States, ³National Cancer Institute Frederick National Laboratory for Cancer Research, Frederick, Maryland, United States

Statement of the Problem: Biobanking studies that collect and share imaging data provide a valuable resource to researchers as imaging data is crucial for correlating clinical, genetic, and pathology findings, and enhancing understanding of disease and treatment strategies. The National Cancer Institute (NCI)’s Cancer Moonshot^SM Biobank (Biobank) collects pre- and post-treatment biospecimens and associated data from over 1000 cancer patients undergoing standard of care treatments.

Proposed Solution: The Biobank generates two types of imaging data: radiological images from participants and histological images from biopsy microscopy slides providing valuable insights into disease progression and treatment response. NCI’s Imaging and Radiation Oncology (IROC) team supports the Biobank by facilitating seamless imaging data submission for the study. The Biobank notifies the IROC team when a participant registers in the study following which the IROC team works with the registering site and helps them to submit imaging data via Transfer of Imaging and Data, web transfer, SFTP, or CD shipment. A quality control process ensures scrubbing of identifiable information from the data and ensures compliance. The University of Arkansas of Medical Sciences team also works with the Biobank’s biorepository team to facilitate the submission of histological images. The Biobank team provides descriptive image metadata and participant information to be integrated with imaging data. The data are then stored, managed, and integrated with The Cancer Imaging Archive (TCIA); this efficient workflow ensures the delivery of a robust data product that is de-identified before they are transferred to TCIA. Once curated, TCIA makes these images available as open data on their portal, enabling researchers worldwide to access and utilize them for scientific studies. The Imaging Data Commons, part of the Cancer Research Data Commons (CRDC), also pulls Biobank images from TCIA on a regular basis. CRDC users can then use Biobank image data and metadata in cloud-based analysis workflows.

Conclusion: The Biobank developed a federated informatics infrastructure and well-defined data sharing plan in alignment with the Cancer Moonshot^SM initiative’s key recommendations of creating a national data ecosystem to facilitate prompt data sharing and analysis. This enabled the Biobank team to be a high-quality resource of biospecimens as well as clinical, biospecimen, and imaging data.

Innovative Technology

PI-01 Maintaining Sample Integrity during Repeated Freeze/Thaw Cycles

A. MacLeod, L. Carter

Azenta US Inc, Burlington, Massachusetts, United States

Background: The frequent requirement to retrieve and re-store biological materials or newly synthesized compounds in −80 C freezers often necessitates repeated freeze/thaw cycles, raising concerns about the potential degradation of sample integrity over time. This study aims to evaluate whether samples stored in high-quality screw-cap sample tubes rated for −80 C storage experience any degradation due to long-term storage or repeated freeze/thaw cycling.

Method: The study employed uniquely designed sample storage tubes of varying volumes, uniformly sealed, with dual threaded cap design, and different treatment types. At predetermined intervals ranging from two weeks to three years, the tubes were removed from −80 C storage, thawed to room temperature, weighed, and visually inspected for any damage such as cracking or grazing. The assessment focused on measuring any changes in sample storage volume, potential tube damage, and the efficacy of the dual-threaded cap design in preventing leakage and evaporation.

Across all tube types and conditions tested, findings indicated minimal weight loss and no physical damage. The consistent performance across different volumes and treatment types highlights the importance of robust cap design and material selection. The double-start thread and compression seal design effectively prevented cross-threading and over-tightening, contributing to the tubes’ durability. Additionally, the use of a polypropylene polymer with low levels of extractables and leachables for both the cap and tube body minimized potential leakage due to differential expansion and contraction, without compromising the sample.

Conclusion: The study confirms that high-quality screw-cap tubes, when properly capped, maintain high sample integrity and exhibit minimal weight loss during long-term −80 C storage and repeated freeze/thaw cycles. These findings demonstrate the suitability of these tubes for biobanking and compound management applications that require multiple sample accesses over time, underscoring the critical role of cap design and material selection in ensuring reliable sample preservation.

PI-02 Automated vs. Manual Ultra-Low-Temperature Sample Storage: A Comparative Analysis of Space Efficiency, Power Consumption, Labor Efficiency, Running Costs, and Carbon Emissions

D. Montano, C. Bercea

Azenta US Inc, Burlington, Massachusetts, United States

Background: Manual ultra-low-temperature (ULT) freezers pose challenges for sample storage and retrieval. Manual freezers have low energy efficiency, and frequent door openings lead to temperature fluctuations and increased energy consumption as the freezer works harder to maintain the required temperature. This, coupled with the use of refrigerant gases, contributes to a high carbon footprint. Moreover, freezer capacity is not optimally utilized due to the need for access aisles and the constant rearrangement of samples, leading to wasted space. The manual retrieval process is time-consuming and labor-intensive, requiring researchers to physically locate and retrieve samples, further slowing down research workflows.

Methods: This model simulates the impact of replacing a large manual ULT freezer collection with an Azenta Life Sciences automated storage and retrieval system. By modeling time, power, space, carbon emissions, and running costs, we demonstrate a 77% reduction in electricity consumption and carbon emissions, an 83% reduction in floorspace, and a 40% reduction in labor hours.

Conclusion: Therefore, significant improvements can be obtained in operational efficiency, cost savings, and environmental sustainability by replacing manual sample storage with automation.

PI-03 Equivalent Results, No Freezers: Room-Temperature Encapsulation for Nucleic Acids

M. Blas¹, C. Chamoun¹, V. Hoelscher², M. Volz², L. Morales², K. Walker², E. Castro², W. Pierce¹, J. Banal¹, S. Dobin², L. Organick¹, K. Youens²

¹Cache DNA, San Carlos, California, United States, ²Baylor Scott & White Research Institute, Temple, Texas, United States

Background: Storing nucleic acid samples often requires −80 C or −20 C freezers, which are costly to purchase, maintain, and monitor, while also occupying substantial space and relying on stable power sources. Together, these factors can severely limit storage capabilities. To date, commercially available room-temperature solutions are either insufficiently scalable or do not offer adequate protection from degradation. For example, formalin fixation and paraffin embedding (FFPE) preserves tissue structures but does a poor job of preserving nucleic acids and creates unique challenges when retrieving nucleic acids. Caching is a new encapsulation technology that allows for long-term storage of nucleic acids at room temperature with a methodology that is easily scalable and automatable. For the first time, this study compares freezing and Caching at the variant level using a clinically validated molecular assay. We found no practical differences in identified variants or variant allele frequency (VAF). This study supports Caching as a potential alternative storage solution for nucleic acids, enabling reliable, long-term storage at room temperature with robust preservation.

Methods: Baylor Scott and White Health (BSWH) and Cache collaboratively set out to investigate the VAF concordance of freezing and Caching. In the completed first aim of the study, 10 de-identified FFPE lung-tumor samples were selected. The age of the block stored at room temperature ranged from four months to six years. After DNA extraction by BSWH, Cache received the samples and from each sample, froze 1 µg at −80 C and Cached 1 µg at room temperature. The samples were held for two weeks, then retrieved and split for technical replicates, shipped back to BSWH, and analyzed using the Agena iPLEX® HS Lung Panel, a MALDI-TOF method for detecting mutations. The identified variants and calculated VAF% were then compared between technical replicates, and between storage conditions.

Conclusions: This study demonstrates variant-level concordance between traditional preservation of nucleic acids at −80 C and the new Caching method. The mean difference in VAF% between frozen and Cached samples was 0.14%. This demonstrates the viability of storing nucleic acids at ambient conditions via Caching. Further aims in this research collaboration are planned to show the concordance of Cached and frozen RNA and DNA from additional tumor types and using other molecular test methodologies.

PI-04 Standardizing the Use of Laser Capture Microdissection in Biobanked Samples to Improve Downstream Genomics Application in Personalized Medicine

S. Liang, A. Azizi, E. Kramer, H. Wagner, N. Fleshner

Princess Margaret Cancer Biobank (PMCB), University Health Network, Toronto, Ontario, Canada

Background: Genomic analyses such as whole genome sequencing (WGS) have become essential for assessing genetic changes in many cancer types before and during personalized therapy. Reliable WGS results depend on the quality and quantity of sequencing samples and the setting of WGS.

Methods: Tumor cell enrichment was conducted using flow sorting on the BD FACSAria III and Laser Capture Microdissection (LCM) on the Leica LMD7000 system. Specimens were obtained through resection or needle biopsy.

The impact of both enrichment techniques on WGS was assessed by analyzing average value of cellularity and variants, including tumor mutational burden (TMB), single nucleotide variants (SNVs), insertions and deletions (Indels), structural variants (SVs), and neo-antigens across 767 samples.

Results: LCM vs. Bulk Samples: LCM was performed on 12 resection specimens, followed by WGS of LCM and bulk samples. In paired analysis (24 samples), cellularity, SNVs, Indels, and SVs increased in LCM samples compared to bulk.

Flow sorting vs. LCM: Flow sorting and LCM were applied to four resection specimens, resulting in eight enriched samples. Flow sorting achieved higher cellularity than LCM. However, LCM showed higher variant values for SNVs, Indels, and SVs.

Given the increased parameters above, the use of LCM prior to downstream genomics increased tumour mutational burden and over all higher coverage [NR1] as well as helping to achieve higher tumour cellularity in submitted samples.

Conclusions: LCM is superior to bulk samples for variant detection and, while FACs sorting shows higher cellularity, it does not yield the same extent of variant findings as LCM. Enhancing tumor coverage in WGS and cellularity in LCM samples improves WGS reliability. Routine application of LCM in tissue preparation for downstream genomics optimizes the use of this scarce resource and facilitates personalized medicine by maximizing the limited specimen utility for WGS. [NR1]If you can clearly clarify how LCM helps to achieve higher TMB and Cellularity, the details can be presented in the poster given the limited word limit.

PI-05 Modular, Automated Storage: A Path to Improved Efficiency and Cost Savings for Biorepositories

M. M. Ng-Almada

Hamilton Storage Technologies, Franklin, Massachusetts, United States

Statement of the Problem: Manual ultra-low- temperature freezers (ULTs) become increasingly difficult to manage operationally as the size of a biorepository grows and the number of manual ULTs increases. There are many good reasons to transition a collection of manual ULTs into a single large, automated storage system, such as faster turnaround time for sample requests, reduced manual labor, safer working conditions for support personnel, reduced laboratory footprint, and reduced energy consumption. Building a return on investment (ROI) case to support purchasing laboratory automation is critical to securing the approvals and investment required to move such an initiative forward; however, it can be challenging to put this type of proposal together.

Proposed Solution: We conducted a comparative analysis of several different hypothetical scenarios of manual ULTs versus automated storage systems in the Hamilton BiOS product line with equivalent sample storage capacity and calculated times to ROI for each. For this, we specifically investigated space efficiency, power consumption, associated labor costs, costs of service and replacement, and carbon emissions for several different biorepository size scenarios. Additionally, we utilized real-world running data collected from existing BiOS installations to estimate additional power consumption savings for each scenario when the storage temperature setpoint is raised from −80 C to −70 C. Furthermore, we put together a model to demonstrate electricity consumption during different phases of system utilization over time in a larger BiOS system installation, as the modular sections of −80 C storage are brought into operation on an as-needed basis. Finally, we summarized some additional qualitative differences between manual ULTs versus automated storage that can be important to an organization when deciding to automate.

Conclusions: When compared to manual freezers, the expected cost savings when transitioning to an automated storage system increases and the time to achieve return on investment decreases, proportional to the size of the biorepository collection being converted to automated storage. Though difficult to quantify but relevant to the value of the biorepository, additional benefits to consider when transitioning from manual ULTs to automation include improved temperature uniformity, faster turnaround time for sample requests, improved uptime, and built-in design features that support disaster mitigation.

PI-06 AI-Facilitated Biobank Sample Identification Optimization

A. Ahmadi^{1, 2}, D. Adamek^{1, 2}, G. Grossman³, V. Menon^{1, 2}, J. Baudry^{1, 2}

¹Department of Biological Sciences, The University of Alabama in Huntsville, Huntsville, Alabama, United States, ²BiobankingAI, Huntsville, Alabama, United States, ³Advancing Sight Network, Birmingham, Alabama, United States

Background: Data-managing tools are widely used across the biobank industry to identify sample for specific customers’ requests. But the process is often hindered by data complexity and volume issues and sub-par big data analytics techniques.

Method and Conclusions: This paper showcases the power of artificial intelligence (AI) in automating data exchange, standardizing formats, and reducing manual errors in analysis biobanking data. By leveraging machine-learning algorithms and integrating large language models, AI can facilitate the identification of patterns and correlations across datasets. We discuss key methodologies, case studies, and potential future developments in AI applications in biobanking.

PI-07 Bridging the Gap: Collaborative Design to Develop DanyBot, a Modular Solution for Biobank Automation

B. Cortes¹, M. Zuñiga², B. Miranda¹, C. Chan³, R. Loaiza¹

¹Labot biobank, San Jose, Costa Rica, ²Cedars-Sinai Medical Center, Los Angeles, California, United States, ³Ingenieria electrica, Universidad de Costa Rica, Puntarenas, Puntarenas, Costa Rica

Background: Biobank automation is essential for maintaining strict standards in sample handling, storage, and traceability. While liquid handling is accessible and cost-effective, tube-handling automation remains limited, costly, and less available, especially for resource-limited biobanks. This lack of automation results in suboptimal use of human and material resources, increased ecological footprint, and potential temperature-related sample degradation.

Methods: We benchmarked both liquid and tube handlers based on technology, cost, and market availability. Incorporating feedback from biobank users and experts, we developed a modular device combining liquid- and tube-handling functions. Using Agile methodologies, our interdisciplinary team optimized resources for design, development, and testing, specifically to enhance accessibility for smaller biobanks.

Results: Compared to tube handlers, liquid handlers offer lower costs, with some open-source models starting at $10,000, a broader range of options, and higher disponibility. DanyBot bridges this gap, providing both liquid- and tube-handling functions through modular, plug-and-play attachments. It assures cryogenic temperatures during standard biobank tasks, reducing refrigerant (dry ice or liquid nitrogen) or energy usage by at least 30%, thus lowering operational costs and environmental impact. User input refined DanyBot’s versatility across applications, establishing its technical maturity at Technology Readiness Level (TRL) ∼7. Additional modules include liquid dispensing and frozen sample aliquoting, with further testing in planned phases.

Conclusion: DanyBot represents a cost-effective, scalable advancement in biobank automation, combining liquid and tube handling to support routine operations in small- and medium-sized facilities. By addressing unmet automation needs through user-driven design and interdisciplinary collaboration, DanyBot enhances biobank efficiency, sample safety, and environmental sustainability. Its adaptable design holds promise for democratizing automation globally, making advanced biobanking technology accessible to a wider range of institutions and geographic areas.

PI-08 A High-Throughput, Rapid, Automated, and Nanoscale SNP Fingerprinting Workflow for Assessing Sample Quality, Integrity, and Contamination for Use in a Biorepository

L. Stewart, B. Hunt

Standard BioTools Inc, South San Francisco, California, United States

Background: Biorepositories provide access to high-quality, curated samples for basic and clinical research purposes. Sample degradation, misidentification and contamination are significant risks to the integrity of banked samples. Distribution of such samples can waste time and laboratory resources and negatively impact the integrity of research studies.

Standard procedures for sample identity and traceability have been employed by biorepositories for many years, including barcode labeling and laboratory information management system tracking. Establishing DNA identity for each sample using a single nucleotide polymorphism (SNP) fingerprinting method is listed in the ISBER Best Practices: Recommendations for Repositories, 5th edition, as part of quality control for nucleic acids. Implementing such a DNA fingerprinting method in the biorepository workflow provides a direct association of sample molecular identity.

Methods: The Advanta Sample ID Genotyping Panel is a 96-SNP assay that generates a sample-specific genetic fingerprint of research specimens at any point in the sample journey. Targeted SNPs, which include 80 in exonic regions to support population prediction, also support the assessment of sample quality and determination of gender identity. In this study SNP fingerprints were created and using the Advanta Sample ID panel with the Biomark X9 System. SNP fingerprint analysis indicates that the panel can be used to assign individual identity, detect sample cross contamination, assess sample quality, and identify samples from the same individual.

Conclusion: Developed for use with the Biomark X9 System for High-Throughput Genomics and based on Standard BioTools microfluidics technology, the workflow uses integrated fluidic circuits to precisely generate multiple datapoints per sample through concurrent, independent assay reactions at nanoliter volumes. In this poster, we demonstrate the utility of the Advanta Sample ID Genotyping Panel and the Biomark X9 System as a sample identity and traceability tool that can be easily implemented into a biorepository operation.

PI-09 QuickConc: Rapid eDNA Concentration and Ambient Temperature Biobanking for Enhanced Environmental DNA Monitoring

R. Iwamoto¹, T. Kuroita¹, W. Qianqian², T. Minamoto²

¹AdvanSentinel Inc., Osaka, Osaka, Japan, ²Graduate School of Human Development and Environment, Kobe University, Kobe, Hyogo, Japan

Background: Environmental DNA (eDNA) analysis is transforming biodiversity monitoring. However, efficient eDNA concentration from dilute samples, especially in resource-limited areas, remains a challenge. Existing methods like filtration are often time-consuming and require specialized equipment and cold-chain preservation, hindering broad adoption in biodiversity hotspots. A robust, field-deployable, and cost-effective strategy for eDNA concentration and preservation is crucial for scaling up monitoring and establishing biobanks. This study introduces QuickConc, a novel method using benzalkonium chloride (BAC) and dispersed glass fibers for rapid, power-free eDNA concentration. We demonstrate successful ambient temperature storage of QuickConc-concentrated eDNA in ATL buffer, enabling accessible biobanking in low-resource settings.

Methods: QuickConc utilizes BAC’s electrostatic interaction with nucleic acids, facilitated by dispersed glass fibers. Water samples (river, sea, pond) were processed by adding glass fibers and BAC, stirring, and recovering fibers with adsorbed eDNA via mesh filtration. This was compared to standard glass fiber and Sterivex filtration. DNA was extracted using a modified DNeasy protocol and quantified. Quality was assessed by qPCR for specific fish species. Metabarcoding using MiFish primers and Illumina sequencing was performed. For ambient storage, QuickConc-concentrated samples in ATL buffer were stored at room temperature for one week and compared to controls via qPCR at intervals.

Results: QuickConc yielded 10 times more DNA than traditional methods, with higher qPCR copy numbers. Metabarcoding showed similar or higher fish species detection with QuickConc. Ambient temperature storage in ATL buffer showed no significant degradation in qPCR copy numbers or changes in qPCR results for at least one week.

Conclusions: QuickConc offers a rapid, efficient, power-free eDNA concentration method surpassing traditional filtration. Crucially, ambient temperature storage in ATL buffer maintains eDNA integrity, revolutionizing biobanking, especially in resource-limited regions without cold-chain infrastructure. This accessible, cost-effective approach facilitates large-scale eDNA biobanking, enhancing biodiversity research, conservation, and collaboration.

PI-10  

PI-11 Methodological Establishment and Optimization of Paraffin Embedding for Trace Organoids

Y. Yang, Y. Chen, S. Zhang, A. Wang, Y. Wang, Y. Gao, J. He, Z. Zhang, K. Zhao, Y. Xing, J. Sun, D. Guo

Peking Union Medical College Hospital, Beijing, Beijing, China

Background: Currently, the culture of rare disease organoids faces many problems, including slow growth of organoids, small sample size, high cost, and long pre-processing time for identification. It is necessary to develop identification methods for trace organoids. In this study, taking ovarian clear cell carcinoma as an example, a method for embedding trace organoids in agarose-encapsulated paraffin-embedded tissues was established. Meanwhile, the effects of fixation time on tissue morphology and target staining were evaluated and optimized.

Methods: Two ovarian cancer samples from Peking Union Medical College Hospital from March 2024 to August 2024 were retrospectively collected. Organoid culture and identification were performed, and 150-300 μL organoid clusters were collected and fixed for 30 minutes, one hour, four hours, and 12 hours, respectively. They were then wrapped in agarose and placed in pre-made agarose blank scaffolds, dehydrated, transparentized, embedded, sectioned, and stained with hematoxylin eosin (HE), pax-8, HNF1-β, ck7, and p16 immunohistochemistry. The differences in HE staining morphology and immunohistochemical positive rates at different fixation times were compared.

Results: This method can reduce the loss of organoids and lower the risk of contamination. There are differences in HE staining morphology. Compared with the traditional 12-hour fixation, there is no difference in four-hour fixation, with distinct nuclear and cytoplasmic staining and clear red and blue colors; however, in 30-minute and one-hour fixation, the cell nuclei appear turbid and the staining is unclear. Compared with the positive rates of pax-8, HNF1-β, ck7, and p16 after 12-hour fixation, there are significant differences in 30-minute and one-hour fixation (p < 0.05); there is no significant difference in positive rates between 12-hour and four-hour fixation (p > 0.05). Different fixation times have an impact on the identification and staining of ovarian clear cell carcinoma organoids, and the staining results of four-hour and 12-hour fixation are superior to those of 30-minute and one-hour fixation.

Conclusion: This study establish method of paraffin-embedded tissue of trace organoids, and through different identification methods of morphology and immunohistochemistry evaluation optimization fixed time, this method is helpful to the identification of trace organoids and follow-up research.

Repository Standards

PJ-01 Optimizing Facilities Management in Biobanks: Developing Effective In-house Equipment Calibration Standards and Procedures

C. Fung, H. Law, C. Or, K. To, R. Ma

CU-Med Biobank, The Chinese University of Hong Kong Faculty of Medicine, Hong Kong, Hong Kong

Background: An effective quality assurance solution is essential for a biobank to pursuit the rising accreditation trends. ISO 20387:2018 emphasizes equipment management, yet developed procedures for in-house biobank operations are lacking. Many biobanks rely on external calibration service providers, but finding one who is ISO17025 accredited is not easy, not to mention the difficulties of arranging calibration schedule for large biobanks. Though outsourcing seems more efficient, it is a burden to budget-constrained biobanks.

Establishing in-house calibration schemes greatly reduces associated costs for any biobank. Enhanced internal capabilities improve equipment management oversight, ensures traceable compliance and documentation, and thus is vital for improving the quality and efficiency while meeting accreditation requirements.

Methods: Standard operating procedures have been developed and optimised for in-house equipment calibration and verification, complying with traceable standards, e.g., ISO 15189, 17025, and 20387. The procedures were tested at CU-Med Biobank to assess feasibility based on reference equipment accessibility, cost/time efficiency, requisite background knowledge, scalability and sustainability, and documentation difficulty.

Currently, the biobank has implemented its calibration and verification protocols in three major facilities: ultra-low-temperature (ULT) freezers, temperature monitoring system, and electronic balances, all maintained internally by trained staff, utilizing externally calibrated reference temperature loggers and weight.

Results: The in-house calibration protocol demonstrated high feasibility in several areas:

1)

Cost efficiency: High cost-efficiency with a significant reduction in maintenance costs for ULT freezers.

2)

Traceability: Standardised and easily recallable in-house documentation enhance traceability.

3)

Sustainability: Training initiatives enhanced staff capabilities, supporting a sustainable calibration scheme.

4)

Scalability: Once established, the scheme secured with trained personnel and a continued access to calibrated reference equipment could easily be scaled up according to needs.

Conclusions: The implementation of in-house equipment calibration protocol demonstrated merits to operational efficiency and sustainability in biobank practices. Its feasibility offers promise for biobanks seeking alternative solutions in facility management to meet accreditation standards.

PJ-03 PBMC Proficiency Testing, Combined with Specific Key Quality Indicators, May Serve as Indicators of Competency and Performance for Similar Processes within the Biorepository, Effectively Monitoring Multiple Processes with a Single Proficiency Test

R. Osborne, M. Joshi

Surgery, Duke University, Durham, North Carolina, United States

Problem: Monitoring quality and integrity of samples within a biobank is a challenging endeavour; sample type, processing method, storage, and operator turnover all interweave to make this complex issue. Substrate Services Core and Research Support (SSCRS), a Duke University School of Medicine Core Facility, averages 5000 collections yearly from multiple research and clinical trial-driven studies. Study collections include microbiome, tissue, and whole blood, all with specific processing and handling requirements, highlighting the importance of monitoring quality metrics for all sample types. Proficiency testing typically focuses on a single sample type or assay; SSCRS required more.

Solution: Training on PBMC separations is complex and more thorough than training on basic blood processing for serum or plasma. An operator that is trained in PBMC separation and participates regularly in a proficiency program will be more highly skilled and qualified to process similar sample types. Over 50% of the studies supported by SSCRS require PBMC separations from whole blood, by monitoring PBMC processes and by including specific key quality indicators (KQIs); all similar processes are, in essence, being monitored. Initially, SSCRS performed monitoring in-house. Operators isolated PBMC and management thawed and assessed the PBMC for viability, recovery, and KQIs. Subsequent testing is now completed by the Immunology & Virology Quality Assessment Center (IVQAC). Quarterly, whole blood is processed for PBMC and shipped to the IVQAC to be thawed and checked for viability and viable recovery. Review of processing data is completed by the SSCRS Data and Management teams to verify accuracy of the data and to ensure that KQIs expected for PBMC processing are met. While a successful test provides verification of individual operator competency in PBMC processing, unsuccessful proficiency testing data have also yielded the following types of findings: data entry errors, improper pipet technique, and standard operating procedures (SOPs) not followed, all of which in turn may have impacted other sample types processed, triggering the need for retraining.

Conclusion: Proficiency tests, when set up correctly, are not only indicators of competency, but may reveal poor technique, such as improper pipetting, the inability to follow directions or SOPS correctly but, ultimately, when successfully completed, give confidence that processes within a laboratory are standardized and sample integrity is maintained.

PJ-04 Expanding the Quality Management Plan to Focus on Patient-Centeredness: The CHTN-SD Experience

M. Copeland, S. McCall, K. Frankey, E. Howington

Pathology, Duke University School of Medicine, Durham, North Carolina, United States

Background: College of American Pathologists-accredited biorepositories including CHTN-SD have quality management plans (QMPs) that address standards, including compliance with applicable regulations for consent and ethical review. Often QMPs include tracking participation rates over time. However, biobank QMPs could examine more “patient-centered” metrics that impact not only participation rates but rates of satisfaction with biorepository participation, and the relative success of the biobank in approaching and recruiting participants representing all communities served by the parent institution.

Methods: CHTN-SD compared biobank participant demographics to those of the cancer patients served by our parent institution from 2014-2019. Data were collected from IRB reports annually and was compared to the Duke Cancer Institute’s (DCI) catchment area.

Results: Hispanic, African American, and Caucasian individuals represented <1.0%, 17%, and 76% of biobank participants while individuals receiving treatment for their primary tumor at DCI were 2% Hispanic, 21% African American, and 72% Caucasian. CHTN-SD also participated in a Community-Scientist Roundtable to gain feedback on participant satisfaction and methods of improving community representation. Panel members indicated biorepository participation is a low-effort, low-risk way to contribute to biomedical research, and also suggested more follow-up communication between the biorepository and the participants (such as a newsletter) was desired to improve satisfaction.

Conclusion: After QMP review of the results, CHTN-SD began taking several steps to achieve full alignment/representation of the communities we serve within the biobank and to address and improve participant satisfaction. Some of these steps have been completed (team members partnered with Cancer Center Community Engagement, attended a Co-Design Seminar Series, and co-designed a more inclusive recruitment flyer) and some are still in progress (newsletter distribution to the community, translation of our consent form into Spanish, and expanding options for consent to include patient-facing applications such as “MyChart”). The demographic breakdown study will be repeated and feedback on the newsletter will be sought after all initiatives are completed, with results compared to prior examination. CHTN-SD will continue (and biorepositories should consider) evolving our existing QMP to include patient-centeredness metrics so that existing frameworks for quality improvement initiatives can be utilized.

PJ-06 Block Quality Index Number (BQIN): Novel Method Suggested for Expressing the Quality and Usability of a Research Grade FFPE Block

S. Ayillath Keezhadath¹, D. Prasan², J. Subramanian², N. Nambiar², A. Balakrishnan², A. N.², V. A.K.²

¹Surgical Oncology, Baby Memorial Hospital, Calicut, Kerala, India, ²64 Codon Pvt. Ltd, Cochin, India

Statement of the Problem: 64 Codon is an open network biobank committed to supporting collaborative research by providing high-quality FFPE blocks to researchers worldwide. Maintaining detailed records of FFPE block quality and usability is critical to our operations. However, existing methods for assessing block quality, primarily using tumor and necrosis percentage values, have limitations. This is because a block with a higher tumor percentage may have lower tumor content than a block with a lower tumor percentage. Consequently, the tumor and necrosis percentages may not accurately represent the block’s value for specific research applications, which can limit the viability of biobank specimens when transferred to researchers.

Proposed Solution: To address this limitation, we propose a new metric called the Block Quality Index Number (BQIN) that provides a more accurate assessment of a block’s usable tumor content. Our approach involves the digital transmission of whole-slide images to pathologists who annotate both tumor and necrotic areas on each slide. Using these annotations, we calculate the total tumor area in microns, subtracting any necrotic regions within the tumor area. This calculation is performed with our algorithm, with the help of specialized software, and yields the BQIN. This can serve as an additional or alternative quality measure to the tumor and necrosis percentage, giving a better indication of the block’s usability.

Conclusion: BQIN offers researchers the ability to specify minimum tumor tissue area requirements, thereby assisting biobanks in categorizing their inventories for better maintenance of records. This method can streamline the identification of blocks that meet specific study criteria, enhancing the efficiency and effectiveness of biobanking operations. Future developments include a more specialized, three-dimensional adaptation of this approach that incorporates average tissue thickness measurements into the BQIN algorithm to measure total available tumor volume, potentially further refining the accuracy of FFPE block assessments for research use.

PJ-07 Revitalizing Historic Repositories: A Methodical Examination of the Past

M. Cruz, F. Anantram, S. Ding, N. Rastegar

University Health Network, Toronto, Ontario, Canada

As biobanking standards of excellence advance through improved quality control programs, standard operating procedures, and biobank information management systems (BIMS), the assessment of legacy specimens to ensure compliance with current biobanking standards is essential. UHN Biospecimen Services (UHN BSP) comprises three recently merged repositories with over 1.2 million specimens banked from as early as 2001. With biobanking best practices evolving over the past 23 years, UHN BSP has implemented several quality assurance (QA) projects to evaluate historical specimens, identify deficiencies, and maintain data consistency across all sample data, both past and present.

In September 2023, a monthly QA project was restarted with the goal of examining 10% of all biofluid specimens stored by UHN BSP. This project aims to identify and correct discrepancies between a sample’s physical condition and its recorded information including volume, storage location, state of specimen identifiers, and specimen condition. Currently, over 17,400 samples have been assessed and 15% of these surveyed samples have been identified with discrepancies that were updated accordingly.

Additionally, a specimen consolidation plan was created to optimize cryostorage space and reduce costs while also reviewing sample data, similar to the monthly QA project. By inspecting over 4300 specimens during consolidation, UHN BSP identified and corrected discrepancies in 18% of the specimens consolidated through this endeavor. Furthermore, by consolidating smaller storage boxes, storage costs were reduced by 30%.

To prepare for the transition to a new BIMS platform, a data clean-up project for historic blood specimens was completed. This project aimed to standardize and consolidate stored legacy data and flag major discrepancies to reduce troubleshooting during BIMS migration. More than 41,000 specimens were reviewed, and relevant information was integrated from multiple data sources for 39% of the reviewed specimens.

QA is critical for biobanks to maintain the integrity and reliability of banked samples and sample data. By extending current quality standards to past specimens, biobanks can ensure that legacy samples are viable for distribution and use in research, maximizing their utility. Moving forward, UHN BSP aims to extend the monthly QA project beyond 10% of the specimens stored and implement future initiatives to assess the qualitative condition of legacy samples.

PJ-08 Challenges in the Collection of Biological Samples from the Operating Room - The Champalimaud Foundation Biobank Experience

H. A. Calá, M. Castillo-Martin, J. Martin-Fernandez

Champalimaud Foundation Biobank, Fundação Champalimaud, Lisbon, Portugal

Background: Biobanks in the health sector are fundamental to the advancement of biomedical research. However, the effectiveness of a biobank depends on the quality, quantity, and accessibility of these samples, as well as compliance with ethical and legal requirements, such as informed consent. The Champalimaud Clinical Centre (CCC) is an oncological Institution with associated research laboratories; thus, the Champalimaud Foundation Biobank (CFB) is a key infrastructure, mainly focused on cancer of the digestive and hepatobiliary tract. The aim of this study is to perform a retrospective analysis of the logistic challenges encountered when collecting biological material from the operating room (OR) and elucidate actions to increase samples’ accrual which could be effectively implemented.

Methods: The CFB generates a list of “possible collections (PC)” every week after receiving the OR schedule, which are used for internal organizational purposes. For this study, we reviewed all PC lists as well as the procurement forms from 2023 and compared the number of samples collected (tissue and blood) with the PC. We then annotated the causes for not collection.

We had a total of 251 planned surgeries for the first semester of 2023, of which 39 were canceled for various reasons, resulting in 212 surgeries performed. A total of 320 samples were collected: 130 tissue samples and 190 blood samples; thus, collection rates resulted in 61.32% and 89.62%, respectively. The most frequent reason for the lack of tissue collection was that the resected specimen was placed in formalin in the OR (81.71%), followed by 12.20% due to the small tumor size, 1.22% due to the absence of macroscopic tumor and another 1.22% due to the lack of identifiable consent at the moment of surgery.

Conclusions: This analysis revealed practices in the OR that could be easily avoided by having a closer communication with the biobank, such as adding formaldehyde for sample fixation and not sending fresh specimen for biobanking. The inability to identify the informed consent at the moment of surgery, although minimal in our case, prevents the ethical use of the samples and could be guaranteed with a better control of the consenting workflow. In certain cases, such as small or macroscopically non-visible tumors, collection becomes impossible due to external biobank factors. This analysis reinforces the need for improvement in collection practices, most of them feasible with better organization.

PJ-10 Duke Human Vaccine Unit (DHVI) Accessioning Unit and Biorepository ISO 20387 Biobank Accreditation

T. Gurley¹, K. Skinner², G. Massey¹, S. Stager¹, C. West², M. Sarzotti-Kelsoe², E. Walter³, M. Moody⁴

¹Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, United States, ²Quality Assurance for Duke Vaccine Immunogenicity Programs, Duke University School of Medicine, Durham, North Carolina, United States, ³Duke Vaccine and Trials Unit, Duke University School of Medicine, Durham, North Carolina, United States, ⁴Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, United States

Background: The Duke Human Vaccine Institute (DHVI) Accessioning Unit and Biorepository (AUB) is a multipurpose unit that has two functions: 1) receipt/accessioning, processing, request/retrieval, and shipping of fresh and frozen clinical and research study specimens and samples (Accessioning Unit) and 2) storage/maintenance of over 1,500,000 samples stored in multiple cold storage units (Biorepository). Since 2012, DHVI AUB support of the clinical and research studies has operated under Good Clinical Laboratory Practice guidelines and has quality oversight by the Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP). Seeking ISO 20387 accreditation would provide investigators with added assurance in accessioning and biobanking in the DHVI AUB.

Objective: International Organization of Standardizations (ISO) 20387 Biobank Accreditation is the gold standard for biobanking which promotes confidence in the biobanking field. Obtaining such international accreditation was the main goal of the DHVI AUB efforts.

Methods: To prepare for the accreditation process the AUB worked with QADVIP to discuss accreditation expectations and then interviewed two accreditation bodies (American Association of Laboratory Accreditation [A2LA] and ANSI National Accreditation Board [ANAB]) to better understand requirements and expectations of each institution. A2LA was selected as the accrediting body and the application process began. The application packet contained the ISO 20387 Biobanking Accreditation Program General Checklist, Technical Staff Matrix for Accreditation, and the Biobanking Scope Document. The application was submitted in the spring of 2023. An initial on-site assessment of the AUB was performed in August 2023. One month after the initial on-site assessment, the A2LA assessor provided a report outlining deficiencies in the AUB based on ISO 20387 Standards. The AUB had three months to respond to the deficiencies and implement corrective actions. Responses were submitted in December 2023.

Results: The DHVI AUB became an A2LA accredited biobank under the ISO 20387:2018 standard in January 2024, becoming one of 10 A2LA ISO 20387 accredited biobanks in the world.

Conclusions: Biobanks are critical for clinical and research studies conducted at Duke and outside of Duke and ISO 20387 Biobanking accreditation provides investigators with confidence when using the DHVI AUB.

PJ-11 Prospective Analysis of Preanalytical Variable Impact on RNA from Placenta

E. A. Schneider¹, M. D. Patton¹, J. J. McIntosh², A. Hopp¹, E. Bernhagen¹, K. Sippel¹, J. Hyatt¹, M. Zogg⁴, H. Weiler³, S. H. Kroft¹

¹Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States, ²Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States, ³Physiology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States, ⁴Translational Glycomics Center, Versiti Blood Research Institute, Milwaukee, Wisconsin, United States

Background: Preanalytical variables impact research. As such, biobanks must maintain fitness for purpose for diverse studies. Based on prior retrospective work, the Medical College of Wisconsin Tissue Bank (MCWTB) prospectively evaluated RNA preparation from placenta samples, assessing the effects of ischemia time (IT), temperature (T), and RNALater (RL) treatment on RNA purity (A260/A280 ratios) and integrity. This work will inform MCWTB collection, processing, and distribution policies.

Methods: From 2018-2019, 26 pieces (each ∼0.025g) of normal fresh placenta were procured from four cases for an N:104. IT included 30-, 60-, 120-, and 240- minutes, as well as 24+ hours. Pending RNA isolation, matched pieces from each IT per case were stored at room temperature and refrigerated (RF, 4 C) before −80 C storage. Each IT included matched untreated (UT), and RL treated samples. Six pieces per case (three UT and three RL) were collected at 30 IT and stored in −80°C for a short (7-15 days), medium (28-31 days), or long time (84-90 days) prior to RNA isolation. Samples were isolated with the QuickGene 810 and Kurabo RNA from Tissue Kit. RNA purity was assessed with a NanoDrop 2000 spectrophotometer as A260/A280 ratios. RNA Integrity (RIN) was measured using a TapeStation (Agilent). Statistical analysis used SPSS to perform descriptive statistics and Generalized Linear Mixed Models (GLMM).

Results: The final N:48 after isolation failures, delays, and RIN measurement failure. The mean purity across all N was 2.06 + 0.065333, the mean concentration was 40.47 + 27.10 ng/µl, and the mean RIN was 5.438 + 1.87. The GLMM of RIN showed a significant impact of treatment with RL (<0.001) but not T (0.505) and the GLMM of RNA purity did not show a significant effect of T (0.245) or treatment (0.475). GLMM of both RIN and RNA purity was not significant for IT.

Conclusions: The reaction failures and delays that caused the loss of IT > 120- samples limits the scope of the experiment. Overall, the current placenta banking processes used by the MCWTB (RF, IT < 120-) produce fit for purpose samples for multiple analyses. Depending on study needs, adding RL could further optimize sample utilization.

PJ-12 The Essential Value of Biobank Samples Monitoring

A. M. Gamal, R. Mohamed, M. Saady, S. Aboelela, A. Ramadan, A. Saleh

Scientific Research, Shefaa Al Orman Oncology Hospital, Luxor, Egypt

Background: Biobanks collect and process a wide variety of biological samples and associated data. They provide a crucial role in cancer research, aiding in the exploration of disease mechanisms, hypothesis testing, and biomarker evaluation from experimental studies. Biobanks decrease the time spent on collecting, storing, and organizing samples.

So, ensuring the integrity and accurate positioning of these samples within freezers to prevent sample mix-ups, degradation, and loss is vital for reliable research outcomes. This abstract highlights the critical need for monitoring the positions and volumes of samples in biobank freezers. As we aim to check sample positions through regular checks to ensure that each sample is correctly placed and easily retrievable.

Methods: In Shefaa Al Orman Oncology Hospital (SOH) biobank our study was conducted to ensure that each aliquot stored two years ago had been correctly placed and recorded with its accurate position, code, and volume. Hence, the storage position of a total of 8700 aliquots of serum, plasma, buffy coat, and DNA extracted samples was verified by comparing the physical location with the recorded data in our inventory management records. Further, aliquots measurements were compared with the recorded volumes to ensure accuracy. Finally, we reviewed all documentation related to the aliquots, including storage logs, and any changes made over the past two years.

Results: by monitoring 8700 aliquots, we identified 30 aliquots with inaccurate volume, representing 0.3%. Specifically, 18 aliquots were recorded as 0.7µ, while their actual volumes were 0.8µ, and 12 aliquots were recorded as 0.9µ, while their actual volumes were 1.0µ. Additionally, 20 aliquots were found in incorrect positions, accounting for 0.2%

Conclusion: Implementing rigorous monitoring protocols has shown a significant reduction in sample misplacement and loss. Hence, regular check of sample positions and volumes in biobank freezers is essential for maintaining the integrity and reliability of stored samples, provides high-quality samples for research, and ultimately contributes to scientific advancements.

PJ-13 Enhancing Quality Control in PBMC Analysis: Integration of Levey-Jennings Charts for Cell Counting and Viability

M. Chowdhury, G. Perera, N. Caixeiro, R. Scolyer

Biobank, Melanoma Institute Australia, North Sydney, New South Wales, Australia

Background: Peripheral blood mononuclear cell (PBMC) analysis is essential to a variety of research and clinical applications. This necessitates stringent and robust quality control measures to ensure accuracy and reproducibility. The Levey-Jennings (L-J) chart provides a practical approach and remains as a useful tool to observe variance in cell counting metrics such as viability and live cells remaining. The L-J chart also allows a visual representation of trends and outliers that are not readily visible.

Methods: An L-J chart framework was developed and tailored to suit PBMC workflows, integrating sequential data from automated cell counting systems (DeNovix CellDrop). Historical data were used to establish control standard deviations (±1 SD, ±2 SD, ±3 SD) and mean values for live cells remaining and viability percentages. Sample data, for live cells remaining and viability percentages were then plotted and assessed for variance and deviations.

Results: Implementation of the L-J chart has enabled instantaneous recognition of QC issues, such as operator variability, equipment calibration, and site variability. Out-of-control signals, such as points beyond ±3 SD and consistent trends outside ±2 SD, triggered targeted corrective actions. Further data are currently being collected to test the robustness of the Levey-Jennings chart and to examine variability in between specimens.

Conclusion: We aim to incorporate Levey-Jennings charts into PBMC analysis workflows to enhance quality assurance by providing a structured approach to monitor process stability. This method aims to support proactive identification of inconsistencies and aims to ensure high standards in PBMC processing and improve the quality of banked samples.

PJ-14 Achieving Compliance to ISBER Best Practices, 5th Edition, Following ISO 9001 Framework and Principles

E. Hendrickson, M. Whaley, A. Namvar, E. Nordren

AFS, American Type Culture Collection, Manassas, Virginia, United States

Background: ATCC Federal Solutions supports federal agencies focused on global health and infectious diseases, biodefense, and chronic diseases. The National Cancer Institute (NCI) at Frederick Central Repository is part of the ATCC Federal Solutions portfolio of government contracts. The NCI at Frederick Central Repository is operated under the Frederick National Laboratory for Cancer Research (FNLCR). ATCC manages and operates the repository under subcontract from Leidos Biomedical Research, Inc. ATCC receives, stores, and distributes biospecimens to clinical investigators supporting cancer research, facilitates study logistics, operates the facilities, ensures the safety of staff, and maintains the quality system. The repository operates at three facilities located in the mid-Atlantic United States. ATCC provides 24/7 emergency response for monitoring storage units and facility equipment.

The repository has an inventory of over 21 million specimens in nearly 900 storage units at temperatures ranging from −196 C to ambient. The average annual inventory activity is 950,000 specimen inputs and 700,000 specimen withdrawals. The repository stores BSL-1 and BSL-2 materials including biological specimens of human and animal origin, as well as environmental specimens as approved by the FNLCR.

Methods: During contract startup in 2016, ATCC implemented a new management system for the NCI at Frederick Central Repository using the framework and principles of ISO 9001, including operational plans, procedures, policies, and training that comply with the ISBER Best Practices (BP). In December of 2024, the repository evaluated the management system using the ISBER Biobank Assessment Tool (BAT), achieving a score of 96.7% against BP 4th ed. In the first quarter of 2025, the repository aims to be the subject of two independent audits against BP 5th ed., to evaluate performance against requirements of multiple stakeholders.

Conclusion: This poster will present the methodology used to define and document the repository’s practices, review the changes required to maintain compliance to BP5, summarize the challenges and barriers to meeting best practices, and conclude with an assessment of the effectiveness for meeting stakeholder expectations by following the ISO 9001 framework and principles to implement the repository’s management system.

PJ-15 Achieving ISO 20387 Accreditation for ATCC Gaithersburg Repository

C. Fuqua, N. Fera, J. Dunn, M. Sherman

American Type Culture Collection, Manassas, Virginia, United States

Background: The International Organization for Standardization (ISO) is a non-governmental organization that ensures quality and parity across processes and procedures. It has published more than 25,000 international standards covering almost all aspects of technology and manufacturing, including biobanking, and is designed to provide practical solutions for real-world problems.

The ISO 20387 standard is designed to assess a biobanking organizations’ competency to provide high quality biological material and associated data management and handling, from acquisition through storage to distribution and disposition. This standard is not currently held by the ATCC Gaithersburg facility and is found to be a more common requirement in the newly released Request For Proposals (RFP).

Methods: Several team members were identified, including subject matter experts, to be responsible for achieving accreditation. The ATCC Gaithersburg facility currently holds an ISO 9001 certification and this knowledge was leveraged to achieve the ISO 20387 accreditation. The Quality Assurance (QA) and ATCC Federal Solutions (AFS) teams reviewed the ISO 20387:2018 and ISO/TR22758:2020 provided by ANAB prior to deciding on an approach. The QA team performed a gap analysis between ATCC’s current processes and the ISO 20387 requirements before completing the biobanking checklist for the accreditation application. All areas of non-applicability were identified and excluded from the accreditation. Additionally, individuals from both teams attended an ISBER training to fully understand the expectations and benefits of becoming ISO 20387 certified.

Results: The team identified that most of the existing documentation being used by the repository met the expectations of the ISO20387:2018 standard. New procedures were drafted to meet additional requirements identified as applicable but not currently met. Achieving this accreditation meets the ATCC mission to provide credible, high-quality products and services to the scientific community as well as enhance the desirability and reliability of AFS.

Conclusions: By comparing ATCC’s current processes to the requirements within ISO 20387, ATCC’s quality management system will become more robust and reliable. With this certification, the ATCC Gaithersburg can confidently respond to additional RFPs that require the ISO 20387 certification.

PJ-16 Establishment of a Quality Control of Data in the Andalusian Public Health System Biobank

A. M. Sánchez-López, J. M. Puerta-Puerta, R. Aguilar-Quesada

Andalusian Public Health System Biobank, Granada, Spain

Statement of the Problem: The Andalusian Public Health System Biobank (SSPA Biobank) works in the frame of a quality management system certified by ISO 9001:2015, which must address any activity that impacts on the quality of samples and their associated data. Moreover, ISO 20387:2018 standard focused on biobanking and has a specific requirement for quality control of data. Although the SSPA Biobank has procedures to maximize accuracy and completeness of data, it has not been established a well-documented quality control of data according to ISO 20387 to improve the access to biological samples and associated data fit for purpose.

Proposed Solution: The analysis of the following operating procedures has been performed to identify the critical data: 1)

Collection or acquisition of biological samples and associated data, including reception.

2)

Preparation and preservation of biological samples.

3)

Request and distribution of biological samples and associated data.

4)

The quality control of data has been defined and documented based on accuracy, completeness, and consistency of data and taking into consideration the data model in the Biobank Inventory Management System (BIMS). Therefore, data in the BIMS have been classified by the corresponding procedure and the process to perform the quality control, including the responsibilities of personnel and the frequency, has been detailed.

Conclusions: A standard operating procedure for quality control of data in the SSPA Biobank has been established. The quality control of data will be implemented and the results will be revised. It will permit us to know if data quality assurance is appropriate to address downstream applications and improve the quality control of data.