The International Society for Biological and Environmental Repositories Presents Abstracts from Its 2024 Annual Meeting

PA‐01 Metrological Traceability in ISO 20387:2018 and Accreditation Programs

C. D. Arant

Life Sciences, A2LA, Frederick, Maryland, United States

Abstract Background: With a relatively new standard comes unfamiliarity with the requirements of traceability and, if applicable, measurement uncertainty. ISO 20387 standard includes a requirement in the appendix devoted to the accuracy of the testing method employed. In addition to maintaining the metrological traceability of the measurement results reported, the biobank shall also ensure critical equipment shall be capable of achieving the accuracy required.

This virtual poster will review the situations where metrological traceability is applicable and the additional requirements that Accreditation Body signatories part of the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) will be required to employ. For example, what level of metrological traceability will a biobank distributing microorganism cells in specified colonies need? Is an automatic cell counter used and are Quality Control samples employed? How do you determine the accuracy of your temperature monitoring devices?

Conclusion: The poster presentation will aim to answer the following questions:

When does a biobank need to be concerned with traceability?

How does a biobank achieve traceability when performing testing/analyzing activities?

Can a biobank perform in‐house calibrations and maintain metrological traceability?

What will be reviewed for biobanks seeking accreditation to ISO 20387?

As involvement in ISO 20387 accreditation grows for all stakeholders, the more education on specific topics within ISO 20387 is needed. This poster will provide practical applications of metrological traceability for biobanks implementing the ISO 20387 standard for their own self administration or for seeking accreditation.

PA‐02 Plasma Collection Centrifugation Temperature of EDTA Tubes for Optimal Plasma Yield for cfMeDIP‐seq

K. Leonard¹, K. McCortney^2,4, J. Walshon^2,4, M. Flowers^2,4, C. Horbinski^2,3, M. DeCuypere^1,2

¹Department of Neurosurgery, Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, ²Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, ³Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, ⁴Malnati Brain Tumor Institute of the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Background: Consistency when processing research specimens is of the utmost importance, especially between biobanks, as it allows for more accurate testing and results to be obtained between investigators. However, not every aspect of specimen processing is studied to determine the top method that yields the best samples. As such, there is no established centrifugation temperature for EDTA tube plasma processing for cell‐free methylated DNA immunoprecipitation and high‐throughput sequencing (cfMeDIP‐seq).

Methods: To investigate this issue, a literature review of 25 studies was conducted and discovered approximately half (11 papers) mentioned specific centrifugation temperatures. Of those 11 papers, eight mentioned using a room temperature (RT) centrifugation, and two mentioned using a chilled (4°C) centrifugation spin for plasma collection. After investigating the literature, we observed our own processing yields between plasma centrifuged at 4°C and at RT. All samples (N = 20) were collected in EDTA BD vacutainer tubes (BD 367861) and centrifuged at 2500 × g for 10 minutes with no break. Samples were collected from pediatric patients (1‐17 years) who consented to participate in research approved by the Lurie Children's Hospital Institutional Review Board (IRB 2021‐4677).

Results: Based on the collected evidence, there is no need to use a chilled centrifuge for plasma collection for cfMeDIP‐seq. Not only does a chilled centrifuge provide no added protection, but it also lowers yield. In the present study, there was an average of 373 μL reduction in yield from plasma centrifuged at 4°C compared to plasma centrifuged at room temperature (P = 0.02). In addition, the literature does not support a specific temperature in regards to prevention of sample contamination.

Conclusions: As the primary focus of a biobank is to be a reliable repository of samples, it is imperative that biobanks are consistent and store the most versatile samples possible. Our results suggest that utilizing a room temperature centrifugation spin for plasma collection from EDTA tubes allows maximum sample yield for later use.

PA‐03 Leveraging the Capabilities of a Global Integrated Analytical Biorepository in Support of Cancer Immunotherapy: The SAMPLED Vector Copy Number Assay

M. Sheldon¹, Y. Ding¹, Y. Wang¹, F. Tu¹, H. He², Z. He², Z. Zhu¹, A. Jadali¹, S. Nahas¹, R. Grimwood¹

¹Sampled, Piscataway, New Jersey, United States, ²Natl. Inst. of Standards and Technology, Gaithersburg, Maryland, United States

Background: The SAMPLED Global Integrated Analytical Biorepository (GIAB) extends the capabilities of the biorepository far beyond the traditional facility that accessions, stores, and retrieves biospecimens, offering the scientific community end‐to‐end solutions to accomplish clinical as well as basic research goals in a CAP‐ and CLIA‐compliant regulated laboratory. These solutions run the gamut from sample collection kit logistics; biospecimen sample processing; analytics, including all multi‐omics platforms; and storage to cold chain logistics for sample distribution on a global scale. This presentation will describe an assay to determine vector copy number (VCN), an important factor in Chimeric Antigen Receptor (CAR) T cell and other gene therapy applications.

Methods: Rigorous monitoring and management of CAR‐T cell dosage are critical to optimizing successful therapeutic outcomes. A number of assays have been developed for the detection of VCN in therapeutic products and patients, the most sensitive and quantitative of which is based on droplet digital PCR (ddPCR). Here, we report the development and validation of a ddPCR assay to detect VCN in the SAMPLED laboratory. To do this, five DNA samples with well characterized lentiviral vector copy numbers extracted from transduced clonal Jurkat cell lines were blinded and run using the Bio‐Rad QX200 ddPCR system with reagents from the manufacturer. Control reactions were run using the housekeeping gene RPP30 as a reference.

Results: Our results quantitated VCN with 100% accuracy in four samples and one detected no target, as expected. Limit of Blank (LOB) was identified as 0 with 95% confidence. The Lowest Input for target detection was estimated as 4.54 copies per reaction at 95% confidence level. Further, the assay is able to detect a target when input DNA was equal or greater than 0.005 ng per reaction. On average, with 10‐ng input per reaction, CV% (Coefficient of variation) of intra‐runs (repeatability) and inter‐runs (reproducibility) of VCN concentration were 1.39% and 1.65% across samples, respectively.

Conclusions: The SAMPLED VCN assay demonstrates high accuracy, precision, and detection resolution with low (<1ng) DNA input per reaction. A GIAB that develops tools such as the VCN assay is uniquely positioned to support critical clinical fields such as cancer immunotherapy as it encompasses sample collection, processing, storage, and distribution, all governed by a uniform quality management program.

PA‐04 NCI's Biospecimen Evidence‐Based Practices for Analysis of Cell‐Free miRNA in Blood Specimens

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

¹Biorepositories and Biospecimen Research Branch, National Cancer Institute, Bethesda, Maryland, United States, ²Preferred Scientific Group, Washington, District of Columbia, United States, ³Kelly Government Solutions, Rockville, Maryland, United States

Statement of Problem: Analysis of cell‐free microRNAs (cfmiRNA) has shown great promise in the clinical diagnosis, treatment, and monitoring of several pathological conditions, including cancer; however, variability introduced during specimen collection and handling has hindered the validation and clinical implementation of cfmiRNA‐based assays. Generation of data‐driven standard operating procedures (SOPs) is a key but costly step in reducing this variability. While trans‐institutional harmonization of pre‐analytical practices would also serve to minimize variability, differences in resources between institutions make the concept of universal SOPs difficult to attain.

Proposed Solution: The National Cancer Institute (NCI)'s Biorepositories and Biospecimen Research Branch (BBRB) has developed a new Biospecimen Evidence‐Based Practices (BEBP) document entitled “Cell‐free miRNA (cfmiRNA): Blood Collection and Processing.” This document is the fourth in the BEBP series and, like the other documents, can serve as a framework for the development of evidence‐based SOPs. The “cfmiRNAs: Blood Collection and Processing BEBP” contains step‐by‐step procedural guidelines on blood collection, processing, storage, extraction, and quality assessment that are tailored specifically for cfmiRNA analysis of plasma and serum. Unlike a traditional SOP, the BEBP includes optimal and, when possible, acceptable practices to accommodate institution‐specific needs and constraints. Additionally, the BEBP contains summaries of the supporting literature on which the recommendations are based and input from experts in the field. Recommendations from the expert panel include suggestions to validate changes in workflow as well as quality thresholds for the delineation of meaningful changes in cfmiRNA levels.

Conclusions: The NCI BEBP series can serve as a framework for the development of evidence‐based SOPs reducing preanalytical variability and increasing harmonization between institutions. The NCI BEBP for cfmiRNA: Blood Collection and Processing is available on NCI BBRB's website (https://biospecimens.cancer.gov/resources/bebp.asp), in the NCI Biospecimen Research Database (https://brd.nci.nih.gov/brd/sop/show/2824), and as supplemental information in the publication announcing its release (https://pubmed.ncbi.nlm.nih.gov/37129007/).

PA‐05 Establishing a Proficiency Testing Program for the Quality Control of Human Biosamples in the National Biobank of Korea

H. Kim, S. Jung, M. Chung, B. Choi, H. Nam, J. Jeon

National Institute of Health, Korea Disease Control and Prevention Agency, Cheongju, Chungcheongbuk‐do, Korea (the Republic of)

The National Biobank of Korea first operated a proficiency testing (PT) program for quality control of biospecimens 10 years ago. In 2022, the NBK acquired the first ISO 20387 accreditation in Korea. In preparation for the inclusion of participation in proficiency testing as an essential accreditation requirement for ISO 20387, we applied the proficiency testing program on a trial basis in 2023 with the goal of obtaining recognition as a proficiency testing provider in accordance with ISO/IEC 17043 quality documents (manual, procedures, instructions). According to the quality document of ISO 17043, we designed the proficiency testing schemes of two schemes (DNA quantity and purity measurements and RNA stability), produced PT items to evaluate the homogeneity and stability, and then distributed the items to participating organizations. After analysis of PT results, we provided feedback reports of PT results and collected opinions from participating organizations to improve the proficiency testing program. In total, 65 institutions participated in the DNA concentration and purity scheme, and 26 institutions in the RNA stability test scheme. Most of the participating institutions were evaluated as “satisfactory.” We will apply the ISO 17043:2023 accreditation in 2024.

PA‐06 Current Status and Support KS J ISO 20387 (General Requirements for Biobanking) in South Korea

K. Ha, J. You, G. Jo, Y. Jeon, T. Jin

KOBIC, Korea Research Institute of Bioscience and Biotechnology, Daejeon, Daejeon, Korea (the Republic of)

The term “bio‐resources” refers to raw materials and tools that are used to conduct biological research. Their acquisition substantially impacts the level of competitiveness in research and industrial operations. With this increasing importance, ISO announced ISO 20387 (Biotechnology– Biobanking– General Requirements for Biobanking) through TC/276 in 2018 for the preservation and quality control of “Biobanking and biological resources,” and Korea accepted ISO 20387 in 2019. Although Korea has quantitatively expanded its bio‐resources and bio‐resource banks through various acquisitional and distributional efforts, quality improvements are still needed. In order to solve this requirements of quality, the Office of Bio‐Resources Planning (OBRP) has collaborated with the Korean Laboratory Accreditation Schemes (KOLAS) since the early introduction of ISO 20387 domestically, and is working to establish the KS J ISO 20387 system in Korea. In this poster, after the introduction of ISO 20387, we will examine the status of certification in Korea and the status of OBRP's support for KS J ISO 20387 activation and explain future plans.

PB‐01 The Journey of Establishing the Westmead Biobank

K. Pryce¹, Y. Wang¹, X. Wang¹, C. Clarke,^1,2 J. Carpenter,^1,2 J. Heads³

¹Westmead Institute for Medical Research, Sydney, New South Wales, Australia

²The University of Sydney, Sydney, New South Wales, Australia

³Macquarie University, Sydney, New South Wales, Australia

Westmead Biobank was initially approved as a core facility of the Westmead Research Hub (WRH) in 2019, following its initial development (phase I) in 2017, which involved information gathering via hub‐wide questionnaire and interviews, and its second development phase (phase II) in 2018, where a pilot project was conducted to establish introductory services. With the initial goal of providing centralized service to WRH partners, Westmead Biobank has since successfully developed a wide range of services from sample processing (e.g., DNA or RNA extraction) and storage, data management to customized service packages. Since March 2018, Westmead biobank has received 107 service enquiries involving 23 groups from five different organizations; 81% (87/107) of the service enquiries have progressed to service delivery and completion while 11% are ongoing services. The remaining inquiries are in the active stage with the potential to progress to services at a later time. Furthermore, as one of the nine WRH core facilities within the Westmead Institute for Medical Research Scientific Platform team, Westmead Biobank is in a unique position to collaborate with other core facilities offering users with advanced one‐stop service packages such as RNAseq, Visium Spatial Transcriptomics Assay. To date, four service packages have established through a joint effort involving Westmead Biobank, Histology, Genomics, and Bioinformatics core facilities. In the next phase of its development and as part of its 5‐year plan, Westmead Biobank is undergoing the New South Wales Statewide Biobank Certification process, implementing a laboratory information management system (LIMS), expanding services to manage multiple collections under a unified governance structure, and streamlining researcher's access to materials. These efforts aim to strengthen the service capability and long‐term sustainability of Westmead Biobank.

PB‐02 Navigating the Biobank Odyssey: Evolution of Cancer Repository at RGCIRC, India

D. Sharma, J. Tayal, A. Sharma, B. Sharma, K. Mehta

Biorepository, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Delhi, India

Background: The biobank serves as a vital resource for research, acting as a crucial link between clinicians, researchers, and pharmaceutical companies conducting drug testing. Its primary role is to provide optimal biosamples for research, and any shortfall in meeting criteria compromises the fundamental function, rendering trials and experiments futile. Therefore, it is essential to systematically reduce sample rejection rates and maintain sample quality in adherence to the highest standards for efficient research outcomes.

Material and Method: To promote translational research in cancer for the long term, we established the Rajiv Gandhi Cancer Institute and Research Centre (RGCIRC) Tumor Repository in 2013. With all regulatory approvals in place, including a steering committee, i.e., Tissue Release Board (TRB), the compact Tumor Repository at RGCIRC was initiated. We built an inventory of quality frozen samples with matched plasma, buffy coat, and formalin‐fixed, paraffin‐embedded (FFPE) blocks for cancer of the breast, ovary, and kidney considering limited funding and infrastructure. To meet growing demands from researchers, we restructured our frameworks to accommodate pan‐cancer indications. In this decade‐old self‐sustainable biorepository, we have seven full‐time employees equipped to handle consenting, sample collection, storage, disbursals, quality assurance, and data management. The Matrix laboratory information management system software streamlines inventory management, sample registration, clinical data annotation, and sample shipments. Annual masterclasses to impart education and training helped us in biobank visibility and researcher outreach. Another value addition was utilising the revenue generated by biorepository to establish a basic research lab and cell culture facility. This led to upscaling from a traditional biobank to a Next‐Generation Biobank.

Result: A total of 7,200 donors have been registered across cancer indications like breast, oral, kidney, ovary, prostate, colon, lung, gallbladder, pancreas, soft tissue, thyroid, melanoma, brain, and stomach cancer contributing to more than 85,000 biosamples (fresh frozen tumor tissue, normal adjacent tissue, plasma, serum, DTC, PBMC, VT, FFPE). Of these, 2023 statistics show a 34% disbursal rate.

Conclusion: The Biorepository at RGCIRC is renowned for its fit‐for‐purpose biosamples with rejection rates as low as 2‐3%. It is an example of a self‐sustainable small‐sized tumor repository making a difference in cancer research.

PB‐03 The CDC and FDA Antimicrobial Resistance Isolate Bank: A Freely, Available Resource to Combat the Threat of Antimicrobial Resistance

M. J. Machado¹, R. Balbuena¹, K. J. Rasheed¹, m. Karlsson^2,1, J. Ilutsik², K. Enoch², J. Haynie², K. Crayton¹, A. McColley², B. B. Yoo¹, R. M. Shawar³, F. H. Benahmed³, C. A. Elkins¹

¹Centers for Disease Control and Prevention, Atlanta, Georgia, United States, ²Goldbelt C6, LLC., Chesapeake, Virginia, United States, ³Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, United States

Background: Antimicrobial resistance (AR) is an urgent global public health threat. In March 2015, the National Action Plan to Combat Antibiotic‐Resistant Bacteria (CARB) was released by the White House. One objective under CARB was to establish a specimen repository of resistant strains to promote the development and evaluation of diagnostic tests and treatments.

Methods: In July 2015, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) launched the CDC & FDA Antimicrobial Resistance Isolate Bank, a curated repository of characterized isolates obtained from the CDC, pharmaceutical and reference laboratories, the FDA, and academia. Isolate characterization includes species identification by Matrix Assisted Laser Desorption Ionization Time of Flight Mass Spectrometry (MALDI‐TOF MS) or 16S rRNA gene sequencing. Whole genome sequencing (WGS) Illumina MiSeq, HiSeq, Oxford Nanopore GridION, and/or PacBio RSII was used for strain typing and AR gene detection and sequence data was uploaded to the National Center for Biotechnology Information (NCBI). Reference broth microdilution or agar dilution was performed to obtain antimicrobial susceptibility testing (AST) data in accordance with Clinical and Laboratory Standards Institute (CLSI) standards. Upon characterization, aliquots were prepared and underwent quality control testing prior to being deposited into the Bank.

Results: The AR Isolate Bank currently holds 33 panels with 1,031 isolates. For each isolate, users can access links to raw and assembled genomes, AR genes detected, as well as reference MIC results along with breakpoints derived from the FDA and CLSI. AR Bank isolates have enabled laboratories to onboard new assays for AR gene detection and facilitated the implementation of updated clinical breakpoints. It has spurred the development of innovative diagnostic methods and therapeutics. Since its inception, ∼9,300 panels containing 333,000 aliquots have been requested and shipped.

Conclusions: The AR Isolate Bank is a free, widely utilized, and unique resource that supports researchers, clinical laboratories, and diagnostic and pharmaceutical companies in the development of innovative diagnostic tests and new antimicrobial agents. Access to highly curated collections has increased the ability to detect emerging AR threats, improved the accuracy of diagnostic testing, and helped validate life‐saving therapies for difficult‐to‐treat pathogens.

PB‐04 Creation of a Heart Institute Biorepository (HIBR)

L. Fist, O. Croweak, J. Alten

Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Statement of the Problem: Congenital heart disease (CHD) is the most prevalent birth defect, thus a critical area of study. Advancement in CHD research is dependent on high‐quality biological specimens paired with granular clinical data.

Proposed Solution: The Heart Institute Biorepository (HIBR) at Cincinnati Children's Hospital is an innovative biobanking initiative of timed biospecimen collections from birth to adult in CHD patients. The highlight of HIBR is temporal collections: pre‐, intra‐, and post‐operatively for all surgical patients, that are stored for future research – aiming to attract researchers interested in any aspect of the body's response(s) to scheduled anesthesia, trauma, ischemia‐reperfusion, or hypothermia occurring with cardiac surgery/cardiopulmonary bypass. HIBR also collects in non‐surgical settings: outpatient clinic, cardiac catheterization, exercise tests, and fetal delivery. The longitudinal approach enables the study of changes in protein and gene expression during the CHD lifespan.

HIBR boasts a diverse array of nearly 100,000 specimens from 4,000+ participants: including biofluids and tissues from the heart, lungs, and fetus, collected over a 12‐year period. Biospecimens are linked to detailed clinical data registries, allowing the integration of phenotypic and outcomes data. This includes patient‐reported outcomes and quality of life survey data from adult participants. To foster transparency and collaboration, all data and assays generated by researchers using HIBR samples are shared with HIBR; this data is linked to each patient's biospecimen catalogue, creating a valuable resource for future research. HIBR will soon collaborate with a biobank from another institution, setting the stage for creation of the first multicenter pediatric cardiac biorepository.

Conclusions: Timed surgical collections provide a unique opportunity for researchers across diverse fields to explore the body's immunological responses and proinflammatory cascade triggered by major stressors. This collection is valuable for those investigating trauma, coagulation, immunology, inflammation, proteomics, pharmacology, metabolism, etc. Longitudinal prospective biospecimen collections paired with robust clinical data spanning an individual's lifetime will improve our ability to understand the genetics and pathophysiology of CHD, predict risk for complications, contribute to the development of new therapeutic targets, and improve clinical outcomes.

PB‐05 PARANOMICs– Discovering the Economy of Parasites and Developing Parasite Biobank in Bangladesh

T. Nath¹, H. Khanum², J. Bhuiyan¹, J. Ju³

¹Parasitology, Sylhet Agricultural University, Sylhet, Sylhet Division, Bangladesh, ²Zoology, University of Dhaka, Dhaka, Dhaka District, Bangladesh, ³Division of Vectors & Parasitic Diseases, Korea Disease Control and Prevention Agency, Cheongju, Chungcheongbuk‐do, Korea (the Republic of)

Biospecimens, carefully curated by experts in the field, are being used strategically for biomedical research, diagnostics, biodiversity, evolution, distributions, and developmental biology. Numerous species, including parasites, go extinct because of rapid climate change, population growth, and unregulated drug use—many of which have never been described. Bangladesh is predicted to have a vast diversity of parasites. However, the economic understanding of parasites is still in the primitive stage in Bangladesh. Thus, a road map has been developed, and we present the first biobank for parasitic biological samples aiming to (a) enhance skills and capacities in the scientific collection of biological samples; (b) serve as a provider of parasite samples for biomedical studies; and (c) maintain quality, consistency, and conservation of highly valued parasite samples and derivatives. At the same time, efforts have been made to compile a checklist of the parasites (human, animal, and environment) prevalent in the country.

Since 2018, this initiative has been carried out by the Sylhet Agricultural University, Bangladesh, in partnership with the Korea Diseases Prevention and Control Agency (KDCA) and International Parasite Resource Bank (iPRB). So far, we have investigated 3,000 human specimens, 5,000 animal specimens, 400 wild animal specimens, 1,000 fish, and 1,500 environmental samples. Morphometric and taxonomic data, as well as the description, quantification, geographic location, and genetic information, were introduced into the database. Well‐preserved specimens and associated data represent a snapshot in time and insights into biological information about past parasite abundance. Based on the experience of all partners the training and educational programs for biobank management will be established. The initiative includes training in scientific collection and identification, preservation, resocialization, IT solutions, and bioinformatics. Until now several hands‐on workshops on “bioresource and biobanking” and “modeling of parasites” have been organized in several public universities.

Establishing this biobank and developing the planned activity will help the world in many ways, including economic, ecological, and transfer to stakeholders.

PB‐07 TBRI Biobank for Liver Diseases: Research Translation and Precision Medicine in Hepatology

M. Zoheiry¹, N. Amin², H. Abu Taleb³, E. EL‐Ahwany¹

¹Immunology, Theodor Bilharz Research Institute, Giza, Giza, Egypt, ²Hematology, Theodor Bilharz Research Institute, Giza, Giza, Egypt, ³Environmental Research, Theodor Bilharz Research Institute, Giza, Giza, Egypt

Background: Liver diseases, including viral infections, nonalcoholic fatty liver disease, autoimmune hepatitis, metabolic diseases, and hepatocellular carcinoma (HCC) are major causes of illness and death worldwide. Thus, there is a need for early diagnostic and prognostic tools to prevent progression of liver diseases. As a result, the need to establish appropriate infrastructure to link high‐quality clinical data with advanced molecular and genetic technologies has become apparent. A cornerstone to achieve this capacity is the development of biobanks that can collect and maintain human bio‐specimens needed to support precision (personalized) medicine. Disease‐specific biobanks have a great impact on the discovery of bio‐markers, targeted drug development, and, in general, research on treatment of diseases.

Proposed Research: The aim of the research is founding a Theodor Bilharz Research Institute (TBRI) biobank that keeps blood, serum, buffy coat, and DNA samples from adult patients having liver diseases. TBRI is a medical research institute affiliated to the Egyptian Ministry of the State for the High Education & Scientific Research. This biobank enables the researchers to analyze detailed clinical information for retrospective and prospective studies and to discover the noninvasive molecular and epigenetic biomarkers that contribute to the detection of liver disorders. TBRI biobank consists of two different parts: 1) The biological material that is collected, processed, and long‐time stored. 2) The database contains clinical and epidemiologic information about patients and information about demographical and clinical data for each sample. With the data gathered from this database, we can investigate the etiology, risk factor, clinical treatment, and other aspects of the complication of the disease. The activities of TBRI biobank essential for its establishment are the following: consenting procedures, data privacy standards, policies preparation, samples procurement, processing sample, preservation standardization, quality management systems (QMS) development, and equipment and systems infrastructure validation.

Conclusions: The TBRI biobank will serve as a center of excellence for best practice and training by being a valuable center of excellence and it will participate in improvement of both public health and individual hepatic patient care in Egypt.

PB‐08 Joint Efforts to Establish a Future‐Proof Pediatric Oncology Biobank in Hungary ‐ The SCOPEDIS Biobank Story

E. Tuboly¹, P. Varga², D. Erdélyi^3,1, G. Kovács^3,1, G. Kriván^4,1

¹Hungarian Pediatric Oncology Network, Budapest, Budapest, Hungary, ²Heim Pál Children's Hospital, Budapest, Hungary, ³Department of Pediatrics, Semmelweis University, Budapest, Hungary, ⁴Department of Pediatric Hematology and Stem Cell Transplantation, Szent László Hospital, Budapest, Hungary

Statement of the Problem: The Hungarian Pediatric Oncology Network was established in 1971 to provide centralized care and population‐based registration for all childhood cancer cases across the country. In its ongoing journey, the Network has achieved significant milestones, including the establishment of a traceable electronic National Registry in 1991, and more recently conducting impactful international research collaborations. Nevertheless, there has been a growing demand for a systematic and harmonized collection of quality biospecimens and associated data for pediatric research that has been severely lacking in the region.

Proposed Solution: By recognizing the significance of future‐proof biobanking, the Network launched the SCOPEDIS Biobank project in 2022. It began with the formulation of the Biobank's scope, mission, and vision, along with identifying essential work packages. Detailed budget estimates and a two‐year timeline covering the Planning, Initiation, and Implementation Phases were proposed, involving planning for the Biobank's facility, resources, and IT infrastructure, and implementing a comprehensive Quality Management System to ensure compliance with regulatory requirements and international biobanking standards. Stage I of the project focused on the procurement of equipment, collection tools, and the entire apparatus required for quality control of biobanking activities. Simultaneously, work began on designing a modular, English‐language Biobank Information Management System application that connects the Registry and the Biobank dataset efficiently.

Conclusion: As of early 2023, the SCOPEDIS Biobank was fully operational, collecting various liquid and solid biospecimens and associated data from pediatric cancer patients across eight collection centers. Rigorous documentation and monitoring occur throughout the pre‐analytical phase. The Biobank adheres to the ISO 20387:2018 standard and the latest international best practice guidelines, which is a unique endeavor in Hungary. Its active engagement in international organizations demonstrates a commitment to sharing both knowledge and research material. To showcase their dedication to ethical and transparent biobanking, a website has been set up to promote participant involvement and public awareness. The SCOPEDIS Biobank exemplifies dedication to the highest quality, offering a state‐of‐the‐art pediatric research infrastructure in the entire Central‐Eastern European region.

PB‐09 Abnormal ECG Associated with T2D and CVD Conditions at Qatar Biobank Population

F. Qafoud^1,2, K. Kunji³, M. Elshrif³, A. Salam⁴, J. Al Suwaidi⁴, N. Asaad⁴, D. Darbar⁵, M. Saad³

¹Qatar Biobank, Qatar Foundation, Doha, Ad Dawhah, Qatar, ²Qatar University, Doha, Ad Dawhah, Qatar, ³Qatar Computing Research Institute, Qatar Foundation, Doha, Ad Dawhah, Qatar, ⁴Heart Hospital, Hamad Medical Corporation, Doha, Ad Dawhah, Qatar, ⁵Division of Cardiology, Department of Medicine, University of Illinois Chicago, Chicago, Illinois, United States

Background: The resting electrocardiogram (ECG) is a non‐invasive diagnostic tool used in clinic to assess the electrical activity of the heart when the patient is at rest. Abnormalities in ECG parameters may be associated with early states of non‐communicable diseases. In this study, we evaluated the association between ECG traits, clinical biomarkers, and medical conditions in the Qatar Biobank (QBB) participants, representing the Middle East population.

Methods: 12‐lead ECG data (including RR, PR, QRS, QTc, PW, and JT) from 13,827 QBB participants were used in this study. Regression model analysis was conducted to identify associations between ECG variables and serum electrolytes, sugar, lipid, blood pressure (BP), blood and inflammatory biomarkers, and diseases (e.g., type 2 diabetes, cardiovascular [CVD], and stroke). ECG‐based and clinical risk scores were developed, and their performance was assessed to predict CVD. Classical regression and machine learning models were used for risk score development.

Results: ECG RR was associated with various biomarkers such as bicarbonate, chloride, HDL‐C, monocytes, glucose, insulin, neutrophil, calcium, and others, as well as the risk of T2D. QRS was positively associated with phosphorus, bicarbonate, and risk of CAD. Elevated QTc was observed in CAD patients whereas decreased QTc was correlated with decreased levels of calcium and potassium. The area under the receiver operating curve reached 0.84 using a machine‐learning model that contains ECG traits, sugar, lipid, serum electrolytes, and cardiovascular disease risk factors. The odds ratio for the top decile of CAD risk score compared to the remaining deciles was 13.99.

Conclusions: ECG abnormalities were associated with serum biomarkers as well as with in T2D and CVD conditions. Risk scores showed great predictive performance to predict CVD.

PB‐10 Familial Atrial Fibrillation (AF) Cohort Study: Middle East Population‐Specific Gene Variants

F. Qafoud^1,2, M. Elshrif³, K. Kunji³, A. Salam⁴, J. Al Suwaidi⁴, N. Asaad⁴, D. Darbar⁵, M. Saad³

¹Qatar Biobank, Qatar Foundation, Doha, Ad Dawhah, Qatar, ²Qatar University, Doha, Ad Dawhah, Qatar, ³Qatar Computing Research Institute, Qatar Foundation, Doha, Ad Dawhah, Qatar, ⁴Hamad Medical Corporation, Doha, Ad Dawhah, Qatar, ⁵Division of Cardiology, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, United States

Background: Atrial Fibrillation (AF) is one of the most common types of arrhythmias. AF patients are in high risk to develop heart failure, dementia, stroke, and possibly death. Genetic variability plays an important role in the development of AF. This study aimed to investigate the genetic architecture of arrhythmia, specifically AF, and cardiomyopathies (CM) in a Middle Eastern population.

Methods: Whole genome sequencing data were used from 14,669 Qatar Biobank participants on a set of 410 genes known to be associated with these conditions.

Results: A total of 1,196 genetic variants were identified. Out of those, 169 P/LP variants were identified to be associated with the medical conditions classified by ClinVar and QCII. Our findings demonstrated P/LP variants with higher frequency compared to other reported populations. The polygenic risk scores (PGS001339, P = 0.025, OR1sd = 1.32 [1.04,1.68]; PGS000727, P = 0.03, OR1sd = 1.43 [1.03,1.97]; PGS001340, P = 0.032, OR1sd = 1.31 [1.02,1.67]; PGS000331, P = 0.034, OR1sd = 1.33 [1.02,1.73]; PGS000035, P = 0.037, OR1sd = 1.29 [1.02,1.65]) were significantly associated with AF with an area under the curve considered as moderate level of accuracy; 21 variants were found to be significantly associated (P < 0.001) with ECG parameters.

Conclusion: This study is a proof of concept of including diverse populations in genomic studies. This reduces the impact of the variant classification variability and phenotypic heterogeneity, revealing new insights into the genetic architecture of arrhythmia, AF, and CM.

PB‐11 Maximizing the Potential of Biorepositories in Clinical Trials: A Collaborative Model

G. J. Mahajan¹, C. Toll², G. Moreno², D. Gamble³, A. Von Eberstein³, M. Hangge⁴, J. Bilyeu⁴, S. Bakkum‐Hansen⁴, P. Ramos⁴, M. Cicek⁵

¹Laboratory Medicine and Pathology, Biorepository Program, Mayo Clinic Arizona, Phoenix, Arizona, United States, ²Biorepository Program, Mayo Clinic Arizona, Phoenix, Arizona, United States, ³Biorepository Program, Mayo Clinic Florida, Jacksonville, Florida, United States, ⁴Biospecimens Accessioning and Processing Core Laboratory, Biorepository Program, Rochester, Mayo Clinic Minnesota, Rochester, Minnesota, United States, ⁵Laboratory Medicine and Pathology, Mayo Clinic Minnesota, Rochester, Minnesota, United States

Statement of the Problem: Biorepositories provide critical support to various clinical trials by collecting, processing, annotating, storing, and shipping biospecimens from trial participants. A collaboration between a biorepository, clinical care team, the sponsor, and clinical trial team can be a powerful tool for advancing medical research. The Mayo Clinic Biorepositories, USA, provide tailored services to support the clinical trials that are conducted by clinician researchers in Mayo Clinic. Non‐standardized clinical trial protocols and the biorepositories that support them can face several challenges, as the lack of standardization can introduce complexities, uncertainties, and increased protocol deviations. The protocol heterogeneity with multiple stake holders with different expectations results in different processing requirements for the same collection protocol. Non‐standardized clinical trials have inconsistent protocols in terms of logistics such as collections, processing storage and shipping of samples. This can affect the sample quality and integrity. There are various strategies and best practices to overcome these challenges.

Proposed Solution: Mayo Clinic Biorepositories practice demonstrates that addressing these challenges requires flexibility, adaptability, and a proactive approach to building relationships and processes that can accommodate the diversity and complexity inherent in non‐standardized clinical trials. Currently biorepositories leadership works closely with study teams, investigators, and industry trial sponsors to establish clear guidelines and harmonize sample collection, processing storage, and shipping procedures to the fullest extent. Effective data integration technologies and interoperable systems with adherence to best practices for sample, data management, and ethical standards are successfully implemented. Long‐term sustainability and scalability are ensured through effective stakeholder communication, collaboration, and adaptable business models responsive to evolving demands.

Conclusion: Overcoming these challenges requires a combination of robust processes, technology, expertise, and collaboration with other stakeholders in the clinical trial ecosystem. It is crucial for the success of the biorepositories supporting clinical trials to have the capability to adapt to varying requirements, encompassing the establishment of standardized samples across trials and continual improvements in operational processes.

PB‐12 The National Serology Reference Laboratory Plasma Sample Repository

K. Woods, K. Zhang, T. Sahin, W. Dimech, P. Hetzel

National Serology Reference Lab, St Vincent's Institute of Medical Research, Fitzroy, Victoria, Australia

Statement of the Problem: The National Serology Reference Laboratory (NRL) is a global leader in the science of quality for infectious disease testing, supporting laboratories in more than 70 countries to ensure accurate, consistent, and reliable results.

The NRL plasma repository is used to support pathology laboratories across Australia and internationally, through access to well‐characterised disease‐state samples. Many laboratories do not have access to required samples in sufficient numbers or volume for assay validation/verification and other quality activities. Access to commercially supplied material is costly and time‐consuming, and the provenance and supply of such samples is often uncertain.

Proposed Solution: Towards the goal of supporting pathology laboratories, NRL has established and maintained over 30 years a sample repository of over 14,000 plasma samples from participants infected with a range of pathogens, including HIV, HBV, HCV, HTLV, and syphilis, alongside healthy donor plasma. These samples are sourced primarily from national blood services across the globe.

The value of any plasma repository is only as good as its characterisation, and therefore extended testing of the plasma is critical. NRL characterises samples using validated testing algorithms and is accredited by NATA as a medical testing laboratory (ISO/IEC 15189) and licenced by the TGA under the cGMP.

NRL also provides External Quality Assessment Schemes (EQAS) to assess the integrity of pathology laboratories' entire process for infectious disease testing. Using samples from the repository, a panel of positive and negative samples are provided to each EQAS participant. Samples are representative of those typically received by the testing laboratory. Following testing each pathology laboratory's data are statistically analysed, and a final report compiled. Laboratories can assess their results and compare their performance with peers.

A new service which the NRL has developed is the provision of well‐annotated panels of disease state samples, which are available for validation and verification of pathology laboratory methods, and to support new assay/IVD development throughout the development pipeline.

Conclusion: To date, the samples held in the NRL plasma repository have supported Australian laboratories for the validation/verification and implementation of their assays, competency testing of staff, research and development, and in quality assurance programs.

PB‐13 Cedars‐Sinai Cancer's OncoBiobank Shared Resource: A New Tool for Cancer‐Based Research

D. Marino¹, D. Pope¹, N. Dagliyan¹, H. Hong², G. Dagliyan², K. Sargsyan¹

¹OncoBiobank, Cedars‐Sinai Medical Center, Los Angeles, California, United States, ²Cancer Center, Cedars Sinai Medical Center, Beverly Hills, California, United States

In the era of precision medicine, biobanking has emerged as a crucial research infrastructure, ensuring that high‐quality, well‐annotated cancer biospecimens are available for various research projects. Cedars‐Sinai Cancer Centers (CSC) OncoBiobank Shared Resource (OBSR) serves as the core of cancer‐focused biobanking services, providing resources for innovative cancer‐focused research. OncoBiobank serves as the cornerstone in addressing the distinct characteristics of cancer biology: its genetic heterogeneity, the vast spectrum of tumor types, and the vital requirement of resources for identifying new biomarkers, developing diagnostic tools, and fostering therapeutic advances.

OBSR is dedicated to improving science and predicting quality control in pre‐analytical workflows for samples and data. Its structure includes three operational levels: 1) A physical biobank, which includes one of the most diverse catchment areas in the United States and various longitudinal cohorts collected in depth by the Molecular Twin Research Umbrella Protocol. 2) A Virtual Biobank ‐ comprising all specimen and patient/donor data: clinical, lab, pathology, and imaging, along with research data from studies. 3) A map of comparable international cohorts to generate immediate validation sites for all our collections. The Molecular Twin Initiative uses advanced data analytics and multi‐dimensional profiling to identify personalized therapies for cancer patients (implementation of Multi‐Omics Databank). It integrates clinical, pathology, and lab data from electronic health records with molecular and sequencing data to create a precision oncology platform. This platform harnesses the power of multi‐omics data analysis, artificial intelligence, and machine learning and has already become a valuable resource for cancer research.

OBSR is devoted to making science better and preaching quality control in pre‐analytics workflows for samples and data. The integration of biospecimen metadata into the Molecular Twin Data Commons aligns with our commitment to advancing precision oncology and accelerating cancer research. This enhances research efficiency by providing researchers with essential information and optimized resource utilization by improving and promoting the discovery of novel treatments and predictive biomarkers. Finally, we believe that this integration is a crucial step toward realizing the full potential of the Molecular Twin platform and achieving our mission to transform cancer care.

PC‐01 Beyond the Bank: A Collaborative Model for Research Project and Clinical Trial Processing

A. J. Mountain^1,2, T. Mckay^1,2, J. Horvath³, S. de Jong⁴, T. Hong⁵, A. Skene^2,5, W. Ng^2,6

¹Austin Health Tissue Bank, Austin Health, Heidelberg, Victoria, Australia, ²Victorian Cancer Biobank Consortium, Melbourne, Victoria, Australia, ³Pathology Clinical Trials, Austin Health, Heidelberg, Victoria, Australia, ⁴Cancer Clinical Trials Centre, Austin Health, Heidelberg, Victoria, Australia, ⁵Anatomical Pathology, Austin Health, Heidelberg, Victoria, Australia, ⁶Cancer Council Victoria, Melbourne, Victoria, Australia

Background: The Austin Health Tissue Bank (AHTB) is one of five consortium sites of the Victorian Cancer Biobank (VCB), based at Austin Health (AH). Located within the Department of Anatomical Pathology (AP), AHTB is uniquely positioned to bridge the gap between VCB, Pathology Clinical Trials, and AP. This position enables specialty processing for complex projects that are outside the scope of AH researchers or the Cancer Clinical Trials Centre (CCTC), while ensuring Standard of Care (SOC) testing and core biobanking activities are maintained. AHTB has a two‐decade relationship with AP and a 10‐year collaborative arrangement with CCTC which supports research and clinical trials at AH.

Method: VCB has developed an efficient workflow where new trials are added to an existing Master Service Agreement. Prior to an application, the CCTC and AH researchers are advised on the allocation of tasks across the department and each group quotes independently for aspects of the project which they will perform. Pathology Clinical Trials and AP manage the SOC testing and AHTB and AP offer bespoke processing.

As a trusted party, AHTB liaises with medical and pathology staff, ensuring that trial requirements for specimens are met. AHTB will deliver specimens to the relevant departments for testing, perform specialty processes, and store or dispatch specimens.

Results: AHTB has successfully maintained a 10‐year collaboration with CCTC through the collaborative infrastructure of VCB and AH. Through this relationship, we have assisted with over 50 researcher‐led or commercially funded trials, each recruiting 5‐40 patients over several years, while continuing routine biobanking. AHTB has the expertise to process PBMC gradient separation, bone marrow aspirates, cerebral spinal fluid, radiological tumour biopsies, and fine needle aspirates, using specialty kits and offering storage, while ensuring that diagnostic tests are performed by AH Pathology.

Conclusion: There are many opportunities for a biobank situated within pathology departments to support research and clinical trials. As a research‐focused biobank within AP, AHTB can facilitate in‐person collections, bespoke processing, and direct specimens for diagnosis and testing. The biobank's ability to coordinate between departments allows for complex, long‐term studies to be undertaken. Conducting efficient “in‐house” research projects and clinical trials strengthens AH's research pillars and continues to build the research community.

PC‐02 Biobank Network Development for Female Breast & Genital Disease Supporting Microbiome Studies

E. Kim^1,8, I. Jang¹, M. Kang^1,7, J. Lee^1,2, M. Noh³, L. Kim⁹, A. Seo⁴, K. Choi⁵, J. Kim⁶

¹Inje Biobank, Inje University Busan Paik Hospital, Busan, Korea, ²Department of Laboratory Medicine, Inje University Busan Paik Hospital, Busan, Korea, ³Department of Pathology, Dong‐a University Hospital, Busan, Korea, ⁴Department of Pathology, Kyungpook National University Hospital, Daegu, Korea, ⁵Department of Pathology, Pusan National University Hospital, Busan, Korea, ⁶Pukyong National University, Busan, Korea, ⁷Department of Pathology, Inje University Busan Paik Hospital, Busan, Korea, ⁸Department of Clinical Pharmacology, Inje University Busan Paik Hospital, Busan, ⁹Department of Pathology, Inha University Hospital, Incheon, Korea

Background: The hospital‐based biobank is to collect, storage, and maintain various types of biospecimens and data that are to be utilized for healthcare R&D. The biobanks should be able to provide human materials that can support current research trends, such as microbiome, that can contribute to the development of future medicine.

Methods: Inje Biobank has participated in the Korea Biobank Network (KBN) project funded by the Korean government since 2011. Inje Biobank, along with four other hospitals, planned to establish a biobank network targeting female breast and genital diseases including microbiome research support (Female Disease Microbiome Network, FDMNet) in 2021. For efficient operation, we looked for ways to reflect the opinions of experts and researchers. It was decided that the target disease and sample types to be collected should be determined, in addition to developing standardized methods of biospecimen collection, storage, and quality control (QC).

Results: The participants were the hospital biobanks of Dong‐A University, Inha University, Kyungpook National University, and Pusan National University. To collect opinions, we established committees and working groups, including standardization, quality management, and equipment & technology committees and breast disease research, OB&GY disease research, and microbiome working groups. The primary target diseases were cancer of the female breast and genital organs and placenta‐related diseases. We also collected biospecimens from healthy people as control cases. Various types of biospecimens have been collected including blood, tissue, urine, stool, cervical and vaginal discharge, DNA, etc. The collection, storage, and QC methods were established and shared as common standard operation procedures (SOPs). There were nine common SOPs. Collected biospecimen cases included 948 cases from breast cancer, 681 cases from female genital cancer, 840 cases from placenta‐related disease, and 117 from healthy cases during 2021 to 2022. Of these, about 31.6 % contained biospecimens for microbiome studies.

Conclusions: FDMNet has been established for female healthcare R&D including microbiome studies. In order to contribute to the development of future medicine, we are striving to become a biobank that reflects the opinions of our customers, researchers and experts.

PC‐03 Prospective Procurement – A Research Model Since 1987 for The Cooperative Human Tissue Network (CHTN) and the Midwestern Division

R. L. Mandt, K. Shilo, A. V. Parwani

Pathology, The Ohio State University, Columbus, Ohio, United States

Background: The Cooperative Human Tissue Network (CHTN), funded by the National Cancer Institute (NCI), was established in 1987 and has continuously provided prospectively procured, high‐quality, remnant human tissue for the academic, government, and industry research communities. The Midwestern Division, one of six currently in the CHTN network, is based at The Ohio State University (OSU) and is one of the original three academic centers who joined the program in 1987. OSU's Tissue Procurement lab prospectively procures and ships fresh, frozen, and fixed samples for active CHTN investigator requests within their region as well as networked CHTN investigators from other CHTN divisions.

Methods: The CHTN's prospective procurement model provides tissue samples to researchers tailored to their specifications and then shipped directly to their labs. Samples include fresh tissue placed in specific medias, cryopreserved frozen samples, and snap frozen samples, as well as fixed, paraffin‐embedded specimens and whole slide digital images. The CHTN Midwestern division only collects samples for active investigator requests and temporarily holds them until quality control is complete (frozen and fixed samples) and then ships them to the investigator for processing. Over the past 36 years the CHTN has been able to stay current with research trends/needs as research methods have evolved and changed as new techniques are developed.

Results: Since 1987 the CHTN organization has shipped over 1.4 million samples to the research community with the CHTN Midwestern Division supplying over 250,000 (18%). There have been over 5,000 publications from investigators using CHTN samples since 1987. The prospective procurement model also reduces the need for multiple freezers and large freezer farms since samples are only collected for active requests and are held for a short period of time. This reduces the overall electricity and liquid nitrogen usage for the biobank, making them less costly to operate.

Conclusions: The CHTN prospective procurement biobanking model has been a valuable resource for the research community for over 30 years and can provide a cost‐effective alternative to the standard biobanking model.

PC‐04 Importance of Biobanking Networks for Diversity of Specimens, Sustainability, and Community Support

M. DeBoer, J. Bartholomew

Oncology Biobank, The Cancer and Hematology Centers, Grand Rapids, Michigan, United States

Most biobanks are systematized as part of an academic institution or within large health care organizations. Creating a diverse biobank within an independent oncology practice is nearly impossible without strong networks, community knowledge, and established processes to obtain a wide variety of specimens for repository.

Population‐based biobanks' sustainability depends on public trust and development of efficient healthcare navigations. The Cancer and Hematology Centers have developed several novel methods of cancer tissue and fluid collection within the nonmetropolitan community setting.

These methods thrive on engaging patients, eliminating treatment team burden, and adding value of specimens to researchers as we learn more about human cancer. When patients know the purpose of their specimen donation, they are excited to partake in making strides towards understanding cancer, developing treatment, earlier detection, quicker diagnosis, and affordable disease monitoring. Established processes to contact and educate patients have demonstrated our efficacy in biobanking enrollment.

Our unique relationship with local hospitals as an independent oncology practice has allowed us access to a large variety of cancer types, stages, mutational status, and treatment histories. Preparedness and communication before the planned collection is crucial to our success. Supplies are ready and patients consented beforehand. Our respect for procedure staff's time creates a mutually trusting relationship. Creating this trust requires a checklist of many visits and phone calls to ensure everyone is well versed on specimen attainment. This constant communication between staff and patients is what creates a sustainable operation.

The diverse community of our patients has allowed us to create a sustainable cancer biobank by having repository of various specimen types for each patient. Tissue samples include tumor debulk and biopsies. Fluid samples include bone marrow aspirate, ascites, and serial collection of whole blood.

CHC has established a human cancer biobank based on strong connections with local healthcare systems, patients, and the community. Through our workflows we have successfully collected samples from within a 13,000 km^2 area and are continually expanding. By having a biorepository of multiple tissue and fluid types from each patient, it creates a diverse scope of opportunity to further research of cancer, progression patterns, diagnosis methods, and treatment efficacies.

PC‐05 Adapting to an Evolving Healthcare Service: Importance of Agility to Avoid a Biobank Steering Off Course

J. Marquez^1,2, S. Higgins², A. Rudge^3,2, M. Daskalakis^4,2, P. King⁵, W. Ng², B. Kumar^6,2

¹Tissue Bank, Pathology, Monash Health, Clayton, Victoria, Australia, ²Victorian Cancer Biobank, Cancer Council Victoria, East Melbourne, Victoria, Australia, ³Tissue Bank, Pathology, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia, ⁴Trials, Pathology, Monash Health, Clayton, Victoria, Australia, ⁵Monash Lung Sleep Allergy and Immunology, Monash Health, Clayton, Victoria, Australia, ⁶Pathology, Monash Health, Clayton, Victoria, Australia

Statement of the Problem: The Monash Health Tissue Bank (MHTB) was established in 2007 as a founding consortium member of the Victorian Cancer Biobank (VCB). The biobanking servicing landscape of the MHTB within the Monash Health precinct includes the Monash Medical Centre, Moorabbin Hospital, Jessie McPherson Private Hospital, Dandenong Hospital, Casey Hospital, and the newly opened Victorian Heart Hospital – making it the largest public service in the state of Victoria.

Under current resourcing and persistent operational challenges, donor recruitment and collection activities experienced a period of reduced activity and evolving to meet service demand was impossible. Furthermore, as each campus has its own specialty unit, ensuring the provision of VCB's priority collection services within each unit is vital for the ongoing research in a variety of tumour streams.

Proposed Solution: To address these challenges in a constrained resources and budget environment, several operational transitions have commenced, including incorporation of biobanking within the local Pathology Trials unit. With case selection, participant consent and sample collection being the core strength of MHTB and VCB Consortium, it was deemed imperative that this remains coordinated by biobanking personnel. Sample processing is transitioning to being performed by Pathology personnel, improving quality by using an accredited service. Furthermore, workflow transitions such as service planning, monitoring using key performance indicators, and reducing inefficiencies through expanding use of available data systems, including cloud‐based quality management systems and participant/specimen software, has enabled further service delivery.

To ensure effective and robust biospecimen storage, MHTB has recently upgraded all aging infrastructure, invested resources in a comprehensive traceability audit, and is transitioning to efficient workflows involving batch transfers to the central storage units of the main campus for long term storage.

Conclusions: Despite continuous healthcare and catchment expansion, applying an agile approach to MHTB/VCB's biobanking activities has ensured continued and increased service delivery impacting a variety of tumour streams. This biobanking model transition demonstrates embracing change when faced with resource adversity, ensuring the biobanking services can better align to current research demand, allowing an increase in healthcare consumer participation in cancer research.

PC‐06 Evolution of a Network to Support Australasia Biobanking

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

¹The Adelaide Biobank, The University of Adelaide, Adelaide, South Australia, Australia, ²Australasian Biospecimen Network Association (ABNA), Parkville, Victoria, Australia, ³Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia, ⁴NSW Regional Biospecimen and Research Services, University of Newcastle, Newcastle, New South Wales, Australia, ⁵UNSW Biospecimen Services, University of New South Wales, Sydney, New South Wales, Australia

Problem Statement: Australasian biobanking has experienced rapid growth and diversification in the last 20 years. This accelerated growth is a testament to the professionalism of Australasian Biobankers, yet there is an enduring need for collaboration to avoid a fragmented biobanking community. Pitfalls such as resource duplication, suboptimal utilization of collections, and siloed collaboration can be avoided through a robust, dynamic network to ensure continued growth and impact.

Proposed Solution: In 2001 ABN‐Onc was formed as a collaborative professional network. In 2009 this evolved to become the Australasian Biospecimen Network Association (ABNA) that, two decades later, continues to work collaboratively, overcoming challenges and achieving pivotal milestones. In 2023 ABNA celebrated their 20th anniversary conference, giving an opportunity to reflect on achievements and the enduring challenges yet to be overcome.

ABNA has connected over 300 members offering individual and institutional memberships, engaging biobankers and industry partners throughout Australasia through sustained outreach initiatives. An ISBER affiliate since 2014, ABNA has initiated networking opportunities that complement ISBER's outreach and educational programs recognising the unique opportunities and needs of the Australasian community. An ongoing focus of ABNA's mission is to facilitate best practice through educational forums and networking events such as annual meetings, member newsletters and online seminar series. To address the challenges of sample utilisation and resource redundancy an expanded specimen locator was re‐launched to reflect the increased diversification and engagement of environmental, zoological, and botanical biobanks. Most recently, the formation of ABNA's Special Interest Groups gives members the opportunity to collaborate within a focused environment, networking in a consolidated fashion around areas of shared interest.

In 2023 ABNA launched the Achievement in Australasian Biobanking Award and Emerging Leaders Scholarship. These dual initiatives will promote a lasting legacy of excellence within the region, nurturing the next generation of biobankers. ABNA continues to contribute to national efforts towards collaborative biobanking initiatives, advocating for national infrastructure and professional recognition.

Conclusion: ABNA continues to be a driving force for collaboration within Australasia and a proud partner of the International biobanking community.

PC‐07 Implementation of Pediatric Biobank in Upper Egypt and its Challenges

M. M. Saady, R. M. Ahmed, A. Moahamed, S. Aboelela, A. Ramadan, H. Fathi, A. Saleh

Scientific Research, Shefa Al‐Orman Oncology Hospital Luxor, Egypt, Luxor, Egypt

Background: Biobanks are considered large collections of human biological materials linked to their personal and health information, like health records, family history, and genetic information that are stored long term for use in health and medical research. Biobank presents an opportunity for scientists to derive knowledge. Specifically, cancer biobanks were related to the hopeful chance of screening, early diagnosis, and treating the disease. However, children are a special population; they differ from adults in physiological and developmental characteristics. They have the right to access the medical services according to the Convention on the Rights of the Child. In addition, there is the medical need to develop child‐specific therapeutic strategies and implementation of basic and translational medical research on children. Nevertheless, we should not forget that it is difficult to perform medical research on children due to issues of study population recruitment and the proper amounts of biological specimens. That is exactly what we face and challenge in implementing the pediatric biobank.

Method: At Shefa Al‐Orman Oncology Hospital (SOH), in 2020 we started targeting children with cancer who are less than or equal to 18 years old and who had not undergone tumor surgery or took medical treatment, whether chemotherapy or radiotherapy, according to our criteria. To minimize the harmful risks, we are recruiting participants at sample withdraw time for routine laboratory tests. The convincing of children is not easy to be applied, so we choose the simplest way and words to enroll them, and we consider the legal and ethical regulations so we must take the approval of their assents.

Result: The number of the enrolled children in SOH‐Biobank was few at the beginning of 2020; it was approximately 20 cases. In 2021 it reached 71 cases. In 2022 we intensified the process of tracking newly diagnosed cases by educating pediatric oncologists about the importance of biobanks for pediatric oncology studies, to be able to recruit the largest number of participants, to reach at the end of 2023 a total number of about 280 cases from different cancer types.

Conclusion: Convincing children to participate in biobank is not easy. In addition, the obstacles of diagnostic process, the health condition of children, and all these issues make the pediatric biobanking so difficult. Therefore, the awareness of pediatricians and nurses is very important to facilitate the process of biobanking.

PC‐08 Importance and Challenges in Implementing a Familial Cancer Biobank in Upper Egypt

R. M. Ahmed¹, S. Aboelela¹, A. Moahamed¹, M. M. Saady¹, A. Ramadan¹, H. Fathi¹, A. Saleh¹, F. Ghaleb²

¹Research and biobank department, Shefa Al‐Orman Oncology Hospital, Luxor, New Tiba, Egypt, ²Central laboratory of Shefaa Alorman Oncology Hospital, Luxor, Egypt

Background: Cancer biobanks are vital for research, diagnosis, and treatment. Thus, enabling the discovery of genetic factors and the development of precise treatments. Targeted therapies now treat more cancers through detection of genetic syndromes, and these improve survival rates. Over decades, global screening programs for cancers like breast, colorectal, and cervical cancer have been deployed. Shefa El Orman Hospital has implemented the Familial Cancer Biobank. Advancements in sequencing technology have identified mutated genes linked to cancer heredity, enhancing genetic screening accessibility.

Methods: We specifically targeted individuals with a family history who met the eligibility criteria outlined in the NCCN guidelines for heredity syndrome. Upon obtaining informed consent, blood samples were collected and placed into two EDTA tubes. Subsequently, the samples centrifuged at 3800 rpm for 10 minutes, then separated into aliquots and stored in ‐80°C freezer. We are facing the following challenges during implementation. The first challenge is lack of awareness; Patients may not understand the importance of donating samples. Cultural and religious concerns exist. To overcome this challenge, training program of the staff to explain the consent process in a simple way is implementing. The second one is limited recourses of equipment and reagents. Technical support in Upper Egypt is difficult to get. Training of staff ensures they can independently operate and maintain biobank equipment. The third: the high costs of genetic testing, which is overcome by actively pursuing grant applications.

Results: Since 2019, about 850 patients have met the criteria. Approximately 3400 aliquots have been collected and stored. Among the participants, 505 have a positive family history, while 345 have a negative family history. DNA extraction has been conducted on positive samples, and sequencing has been completed for 40 of these samples.

Conclusion: The susceptibility of hereditary cancer syndromes can be determined through pre‐test evaluation, to determine the inheritance type with pedigree analysis, the genetic analysis for genes and cancer type. Screening of cancer high risk families may facilitate the diagnosis of asymptomatic individuals and the early management of cancer once it develops, in addition, these families will be provided with an opportunity to join the early detection cancer programs.

PC‐10 WITHDRAWN

PC‐11 Empowering Biomedical Research in Brazil: Implementation of the Fiocruz Biobank Network

D. Sertorio, T. Amaral, C. Stefanoff, A. Daher

Fundacao Oswaldo Cruz, Rio de Janeiro, RJ, Brazil

The Oswaldo Cruz Foundation – Fiocruz is a public institution, linked to the Brazilian Ministry of Health, and has a mission to produce, disseminate, and share knowledge and technologies aimed at strengthening the National Unified Health System –SUS and contributing to the promotion of health and quality of life of the Brazilian population. Fiocruz is the most prominent institution of science and technology in health in Latin America, with 17 units and five offices in 11 of the 27 states of Brazil and partnerships around the globe. Considering that Brazil has an immense genetic diversity, due to the constitution of its population, the country has an enormous potential for scientific research and medical advancements. The Fiocruz Biobank Network (RFBB, from the Portuguese Rede Fiocruz de Biobancos) is a collaborative public service that provides access to human biological materials meeting, with quality, ethics, and the current and future needs of research in Brazil aiding the generation of knowledge focusing on public health.

The Fiocruz Biobank Network, starting in 2015, formed a Steering Committee with members from all Units. It opted for a network with decentralized biobanks. Each one is registered with the National Research Ethics Commission‐ Conep. RFBB integrates biobanks, harmonizes protocols, multiplies and improves them, partners with external institutions, and supports biobanks in defining collections, acquiring equipment, standard operating procedures (SOPs), and regulatory documents for Conep accreditation. RFBB offers a BIMS for a unified platform with harmonized variables. The Ministry of Health financially supported RFBB.

The Steering Committee built the statute of the network and its SOPs. It acts in seven working groups dedicated to improving quality, governance, harmonization of SOPs, BIMS, compliance with ethical standards, communication, and education. RFBB has seven biobanks; four of them are registered and three are being developed and in process of national accreditation with Conep.

Fiocruz has walked a long path to establish a network with institutional biobanks; considering the continental size of the Foundation, the establishment of a network with decentralized Biobanks was the best possible choice, and a good way to support biobanks to guarantee quality in processes and rational application of public resources. RFBB has a lot of potential to grow with new biobanks and establishing partnerships and alliances locally and abroad.

PC‐12 Benefits of Long‐Term Collaboration between a Biobank and Academic and Commercial Clients

S. Hume², A. Martyn², C. Schneider², C. Gilfillan², J. B. Hess¹

¹Victorian Cancer Biobank, Melbourne, Victoria, Australia, ²Eastern Health, Box Hill, Victoria, Australia

Statement of the Problem: The journey from research discoveries to commercial application depends on a reliable source of high‐quality biological material and can take many years. To facilitate this process, researchers require crucial access to fresh and archival biospecimens over the course of a project's lifetime. However, accessing this resource is challenging for scientists, especially those who have no connection with clinical institutions.

Proposed Solution: The Victorian Cancer Biobank (VCB) Consortium is a network of biobanks with harmonised procedures and centralised open‐access governance with a broad consent model servicing diverse projects for academic and commercial clients, including both short‐ and long‐term projects. The consistency and reliability of this model ensures the long‐term collaboration between biobanks and researchers enabling cancer research from initial academic discovery to commercial translation.

This work describes a case study that demonstrates the supportive role of biobanking in discovery and commercialisation of a product for early detection of colorectal cancer.

Over a period of 9 years, the Eastern Health Tissue Bank, a member of the VCB, along with consortium assistance facilitated access to patient material from surgical procedures, resulting in the supply of 4,501 samples to an academic project. The support provided by the VCB was instrumental in foundation research and resulted in colorectal cancer biomarker discovery. Collaboration with a commercial client using this research was then the basis for development of a novel product for early detection of colorectal cancer. Over another 4 years, further support to the commercial client allowed banking of an additional 2,495 samples to perform validation studies of the diagnostic test.

Conclusion: Access to biospecimens is crucial for basic science discoveries and validation studies in the commercialisation pipeline. A collaborative streamlined biobanking model with equitable open‐access governance is needed to support this entire process.

The VCB, as an established leading Victorian biobanking infrastructure, has shown that biobanks are optimally positioned to deliver biobanking requests enabling equitable and long‐term access for academic and commercial partners, with flexibility to meet client needs including bespoke collections.

PC‐13 Spanish National Brain Metastasis Network (RENACER): A Multidisciplinary Approach for the Generation of a “Living” Brain Metastasis Cohort

E. Ortega‐Paino¹, M. Artiga¹, C. Sobrino¹, N. Ajenjo¹, J. Escolano¹, D. Alba¹, I. Almenara¹, P. Baena², F. Al‐Sharhour³, M. Valiente²

¹Biobank, Centro Nacional de Investigaciones Oncologicas, Madrid, Madrid, Spain, ²Brain Metastasis Unit, Centro Nacional de Investigaciones Oncologicas, Madrid, Madrid, Spain, ³Bioinformatic Unit, Centro Nacional de Investigaciones Oncologicas, Madrid, Madrid, Spain

Statement of the Problem: Brain metastasis (BrM) is a common finding (10%‐30%) in prevalent cancers (lung, breast, skin cancer). BrM diagnosis implies poor prognosis and a marked decrease in the patient's quality of life. Due to the brain microenvironment particularities (cell types, anatomical structures, metabolic constraints, and immune environment) these metastases are very heterogeneous and present a different molecular profile compared to their corresponding primary tumour. Alterations that may appear could contribute to a particular genomic composition, which could be used as a therapeutic object or guide for the selection of pharmacological treatments in BrM. Therefore, there is a need of human material to address this unmet clinical need.

Proposed Solution: To face these challenges, the Spanish Brain Metastasis Network (RENACER) presents a novel strategy focused on the study of BrM through a new multidisciplinary patient‐centered perspective and a unique collection of human samples to promote research and to contribute to the discovery of new therapeutic targets and novel therapeutic approaches to address this unmet clinical need and in a continuing effort to benefit patients. RENACER is established at national level, with international vision, formed by health institutions, basic/translational laboratories, and a biobank, which has already created a unique cohort. The work developed is based on harmonization efforts mainly regarding technical procedures, ethical requirements, and a unified quality control policy, combined with a multidisciplinary vision to understand the particularities of this disease.

In addition, a unique pipeline has been developed, including the coordination of neurosurgeries, sending of “live” samples, processing, RNAseq, WES, and bioinformatics analysis, and the incorporation of drug‐screening platform (METPlatform), which enables to correlate the genomic classification of patients with possible pharmacological treatments, facilitating in a short term to personalise treatments according to the specific properties of the tumour. All this information will be gathered in a Datal Portal following FAIR principles.

Conclusions: Multidisciplinary patient‐centered networks offer access to difficult‐to‐get samples. Such networks to include “living” samples together with a data portal could be transformative, not only for research but for clinical trial design, especially when focused on unmet clinical needs, such as brain metastasis.

PD‐01 Veterinary Biorepository: Significance of Standardization, Biosafety, Biosecurity, and Data Management

P. Johnston

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

Veterinary Biorepositories provide biological samples that enable researchers to comprehend animal disease, create novel diagnostics and therapies, and integrate molecular genetic information into livestock breeding programs. The primary functions of veterinary biorepositories include collecting, analysing, preserving, and storing biological samples as well as granting access to them. Biorepositories must guarantee proper sample and data quality, legal and ethical compliance, as well as transparent and efficient access processes. Unfortunately, the absence of standards consistent with best practices and the required infrastructure is a considerable barrier to sample reliability and reproducibility. The Agricultural Research Council‐Onderstepoort Veterinary Research (ARC‐OVR) established a biorepository with the aim of providing a secure facility for processing, storage, and maintenance of quality biological samples within the campus. The biological samples at the ARC‐OVR must be stored properly and safely with a careful view to maintaining sample integrity over lengthy periods of time (around 30 years). Hence, ARC‐OVR focused on the following areas: sample type, data recording, quality management system, biosafety, biosecurity, and personnel. Several challenges were experienced; the infrastructure does not meet the requirements due to number of security issues. Resources are limited, mainly in terms of reliable power and internet connectivity. The lifespan of freezer compressors and other equipment is shortened by power outages, 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 as sources of funding are often 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. Biorepositories must guarantee 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 build a specialized, high‐quality, and access‐controlled infrastructure. Such a biorepository would use the 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.

PD‐02 LARRRC, the First Biobank Acquired the KS J ISO 20387 Accreditation (Animal Filed) in Korea

S. Choe², M. Kang², K. Lee¹, W. Yoon¹, M. Lee¹, H. Kim¹, K. Nam¹, J. Huh²

¹Laboratory Animal Resource & Research Center, Korea Research Institute of Bioscience and Biotechnology, Daejeon, Cheongju, Korea (the Republic of), ²National Primate Research Center, Korea Research Institute of Bioscience and Biotechnology, Daejeon, Cheongju, Korea (the Republic of)

Background: The Ministry of Science and Technology in Korea has established the “Animal Model Cluster”, composed of various animal model biobanks. In the total of eight animal model biobanks, the Mouse Resource Biobank (LARRC) has been appointed as the central bank, tasked with supporting the standardization of BMaD for animal model biobanks. The Mouse Resource Biobank operates the biobank with a quality management system ensured by the KS Q ISO 9001. However, for the standardization of animal model resources, we have chosen to introduce the biobanking standard, KS J ISO 20387:2018.

Methods: Firstly, in accordance with the KOLAS accreditation scheme, we defined the biobanking activities and the accreditation scope for three types of biological materials in the field of animals: “organisms,” “embryos,” and “other (sperm).” Then, in order to comply with the structural requirements of ISO 20387, we have designated the organizational structure with “top management” responsible for the overall operation of the biobank and “personnel” equipped with professional competence and receiving appropriate education. Secondly, we have improved all documentation, processes, systems, and records to meet the requirements of ISO 20387 maintaining the system of ISO 9001.

Results: After submitting the accreditation application, we underwent evaluation processes including “document review” and “on‐site assessment” by the assessment team from KOLAS. We have completed corrective actions for all nonconforming output identified during the evaluation process. Several nonconforming outputs were concerned with the transport of biological material and equipment, which are important to ensure the integrity of the biological material. Finally, the accreditation has been officially decided following the deliberation of the accreditation committee. The Mouse Resource Biobank is accredited by KOLAS for biobanking activities related to the acquisition, preparation, storage, and distribution of biological materials (individual, embryo, and other [sperm]), as well as associated data.

Conclusions: The Mouse Resource Biobank has become the first in Korea to successfully accredited biobank in the animal field under the KS J ISO 20387:2018 standard. In particular, we emphasize that we are the first “individual” scope within the animal field.

PE‐01 Moringa Oleifera Leaf Extract as an Alternative to Antibiotics for Buffalo Semen Cryopreservation

S. Akhter¹, A. Awan¹, B. A. Rakha¹, A. Riaz², J. Arshad¹, I. Qadeer¹, S. Iqbal³

¹Zoology, Wildlife and Fisheries, PMAS‐Arid Agriculture University Rawalpindi, Rawalpindi, Punjab, Pakistan, ²Department of Parasitology and Microbiology, Pir Mehr Ali Shah Arid Agriculture University Rawalpindi, Rawalpindi, Punjab, Pakistan, ³Livestock Breeding Services Authority, Livestock Breeding Services Authority, Government of Punjab, Lahore, Punjab, Pakistan

Background: The extensive use of antibiotics clearly drives the evolution of antibiotic resistance, a serious global threat that demands the exploration of natural alternatives of antibiotics.

Methods: The objective was to evaluate the Moringa oleifera (MO) leaf extract as an alternative to antibiotics in extenders for post thaw sperm quality and total aerobic bacterial count (TABC) of cryopreserved Nili‐Ravi buffalo bull semen. The MO leaves were used for preparation of methanolic extract that was screened for the presence of phytochemicals by using standard chemical tests. In vitro dose tolerability of buffalo sperm to MO leaf extract was assessed by incubating semen samples from four bulls (eight ejaculates/replicate, three replicates) in sodium citrate buffer supplemented with 0, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, and 4%, of MO extract. For cryopreservation, semen from four bulls (eight ejaculates/replicate, three replicates) was cryopreserved with Tris‐citric acid egg yolk extender supplemented with MO extract (v/v): M1 (0.5%), M2 (1%), M3 (1.5%), M4 (2%), M5 (2.5%) and control (with antibiotics streptomycin–penicillin).

Results: In vitro dose tolerability of buffalo sperm to MO leaf extract showed an increasing trend of sperm progressive motility (%) from 0.5% to 1% of extract, and decreasing trend from 1.5% to 4% of extract. The percentage of post thaw sperm progressive motility, viability, livability, and acrosome integrity was higher (P ≤ 0.05) in extender M2 (supplemented with 1% MO extract) compared to control, while plasma membrane integrity values remained similar (P ≤ 0.05) in all treatments. The TABC was significantly lower (P ≤ 0.05) in extenders supplemented at all levels of MO extract compared to control.

Conclusions: Moringa oleifera leaf extract as an alternative to antibiotics (streptomycin–penicillin) in extenders improved post thaw sperm quality and reduced total aerobic bacterial count of cryopreserved Nili‐Ravi buffalo bull semen.

PE‐02 Evaluation of the Quality of SARS‐CoV‐2‐Positive Nasopharyngeal Samples Stored in Liquid Nitrogen at the Biobank (Pasteur Institute of Côte d'Ivoire)

R. J. Bouagnon

Pasteur Institute of Ivory Coast, Cote d'Ivoire Ministere de la culture et de la Franciophonie Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire

The SARS‐CoV‐2 positive samples from the COVID‐19 pandemic surveillance were subjected to quality control after storage at the biobank of the Pasteur Institute of Côte d'Ivoire. They were evaluated one year after their cryopreservation by a polymerase chain reaction (PCR) test and the threshold values of the cycle were recorded. PCR test results indicated 100% concordance of all nasopharyngeal specimens that tested positive for SARS‐CoV‐2. It appears that nasopharyngeal samples packaged in high‐security straws and stored at ‐196°C are still viable for detecting SARS‐CoV‐2 after one year of storage. A reproducibility of the preservation protocol can be carried out to standardize the preservation technique. An annual program for evaluating the conservation of samples can be instituted at the biobank as a form of quality control.

PE‐03 Quantitative PCR‐Based Method for Assessing the Quality of Plasma DNA Using Single‐ and Multi‐copy Reference Genes

J. Shin^1,2, E. Kim^4,5, S. Oh³, J. Lee^1,5

¹Laboratory medicine, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ²Paik Institute for Clinical Research, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ³Laboratory medicine, Pusan National University School of Medicine, Yangsan, Korea (the Republic of), ⁴Clinical pharmacology, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of), ⁵Inje Biobank, Inje University Busan Paik Hospital, Busan, Busan, Korea (the Republic of)

Background: Circulating cell‐free DNA (cfDNA), including tumor‐derived circulating tumor DNA, is a promising cancer biomarker. Optimizing cfDNA purification methods and storage techniques to prevent leukocyte DNA contamination is essential. Accurately assessing and quantifying plasma DNA is necessary. This study explores the use of housekeeping genes as a quality index for plasma DNA.

Methods: We selected two genes: LINE‐1 and TOP1. LINE‐1 (L1) is a multi‐copy gene belonging to the family of human retrotransposons, while TOP1 is a single‐copy gene that controls DNA topological states during transcription. We designed two primer pairs to amplify both cfDNA and contaminating gDNA, resulting in short‐ and long‐strand amplicons, respectively. Real‐time quantitative PCR (qPCR) was used to determine the copy number (CN) of the small and large amplicons for the two target genes. We compared the CN and its ratio between the small and large amplicons (S/L ratio) in artificially fragmented DNA by sonication, K2EDTA plasma DNA stored under different temperature conditions (4°C vs. 25°C), storage time periods (1, 3, 7, and 14 days), and cfDNA obtained from a Streck tube.

Results: The S‐L ratio of L1 and TOP1 increased proportionally with the fragmentation degree (up to 174 bp), respectively. The S‐L ratio of TOP1 is more sensitive to the fragmentation degree. The median S/L ratios of L1 and TOP1 from the Streck tube (immediate cfDNA extraction) were 1.24 and 1.14, respectively. When plasma DNA was extracted using three different commercial kits, the median S/L ratios of L1 and TOP1 mostly dropped on the third day of storage compared to the first day. The changes in S/L ratios of L1 at 25°C were as follows: 1.17 → 1.04 (Bioneer), 1.09 → 1.01 (Qiagen), and 1.04 → 0.92 (ABI).

Conclusions: We developed and assessed a qPCR assay using single‐ and multi‐copy reference genes to quantify and evaluate the degree of plasma DNA fragmentation. The copy number ratio of small and large amplicons represents the fragmentation status of sheared DNA. This assay serves as an additional tool for assessing the status of plasma DNA.

PE‐04 Preservation of Functionality, Immunophenotype, and Recovery of HIV RNA from PBMCs Cryopreserved for more than 20 years.

K. Merlin¹, K. Suzuki¹, W. B. Dyer^2,3, A. Lloyd³, J. Zaunders¹

¹NSW State Reference Laboratory for HIV, St Vincent's Centre for Applied Medical Research, Darlinghurst, New South Wales, Australia, ²Australian Red Cross Lifeblood New South Wales and Australian Capital Territory, Alexandria, New South Wales, Australia, ³UNSW Kirby Institute, Sydney, New South Wales, Australia

Background: Long‐term cryopreserved peripheral blood mononuclear cells (PBMCs) increasingly take up resources, but are of uncertain utility for immunological studies. We investigated preservation of immunophenotypes and in vitro functionality of cryopreserved PBMCs after >20 years, including samples from viraemic human immunodeficiency virus‐positive (HIV+) patients and healthy seronegative controls, respectively. We compared the results to recently cryopreserved PBMCs, and to immunophenotyping from original blood draws >20 years ago.

Methods: PBMCs were thawed, tested for viability, then immunophenotyped by 18‐colour flow cytometry for major subsets of T, B, and NK lymphocytes and myeloid cells. Some T cell markers could be compared with results from the original fresh blood draw. Functionality was assessed by culture with influenza lysate or polyclonal T cell activation (anti‐CD3/28/2), for 2‐day CD25/CD134(OX40) upregulation on CD4 T cells, and 7‐day proliferation of CD25+CD4+ blasts. RNA was extracted from cultures containing CD25+CD4+ blasts and intracellular HIV RNA was measured using the Double‐R pi‐code assay and sequenced by the Sanger method.

Results: All lymphocyte, monocyte, and dendritic cell populations and major T cell subsets were preserved after >20 years cryostorage, except for a large decline in the proportions of activated CD38+HLA‐DR+ T cells in both CD4 and CD8 T cells from the HIV+ PBMC samples. Also, there were some differences in T cell subpopulations between the long‐term cryopreserved PBMCs and recently cryopreserved PBMCs, however, most likely reflecting participant age‐ and HIV infection‐associated effects. Proportions of naïve, memory, and effector T cell subsets were correlated with the original analyses, decades earlier. Antigen‐specific and polyclonal T cell responses were readily detected in cryopreserved PBMCs from both HIV+ patients and healthy control donors. We were also able to activate production of HIV RNA from cultured PBMCs after 27 years' cryopreservation.

Conclusions: Our study provides a strong rationale for the utility of well‐maintained biorepositories to support immunovirological research even decades after collection. The St Vincent's Centre for Applied Medical Research Biorepository is currently holding more than 32,000 PBMC vials that fall into the “greater than 20 years old” category and this study will help justify the continuation of this important biospecimen storage.

PE‐05 Early Life Nutrition Factors and Risk of Acute Leukemia in Children: Systematic Review and Meta‐Analysis

K. A. Kintossou¹, J. Blanco‐Lopez², I. Iguacel³, S. Pisanu⁴, C. C. Almeida⁵, E. Steliarova‐Foucher⁶, M. Gunter⁷, E. Ladas⁸, R. Barr⁹, K. Van Herck⁶, Z. Kozlakidis², I. Huybrechts²

¹Biobank, Institut Pasteur de Cote d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire, ²International Agency for Research on Cancer, Lyon, Rhône‐Alpes, France, ³Universidad de Zaragoza, Zaragoza, Aragón, Spain, ⁴Universita degli Studi di Cagliari Dipartimento di Scienze della Vita e dell'Ambiente, Monserrato, Sardegna, Italy, ⁵Universidade Federal do Parana, Curitiba, PR, Brazil, ⁶Universiteit Gent Faculteit Geneeskunde en Gezondheidswetenschappen, Gent, Belgium, ⁷Imperial College London Faculty of Medicine, London, United Kingdom, ⁸Columbia University Irving Medical Center, New York, New York, United States, ⁹McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada

Background: Acute leukemia commonly occurs in young children with peak incidence at the age of 2‐5 years. However, the etiology is still unclear and many preventable risk factors still deserve to be reviewed. The focus of this systematic review and meta‐analysis is to summarize the evidence concerning early life nourishment (breastfeeding, early life diet), neonatal vitamin K administration. and the risk of acute leukemia.

Methods: All epidemiological studies published up to June 2023 and assessing diet‐related risk factors for childhood acute leukemia were identified in two electronic databases (PubMed and Web of Science), with no limits on publication year or language.

Results: A total of 38 studies (37 case‐control studies and one study with pooled analysis) were included. The published risk estimates were combined into a meta‐analysis using the Generic Inverse Variance method. The current evidence shows that breast feeding (yes vs. no) has a protective effect against acute lymphoblastic leukemia (odds ratio = 0.85; 95% CI, 0.76–0.94). Evidence related to the role of other studied factors (foods and supplements) is inconclusive.

Conclusion: Further research into the potential role of diet in early life and the risk of acute leukemia is needed to develop prevention strategies at population level. Review Registration: PROSPERO registration no. CRD42019128937.

PE‐06 Trehalose Cryopreservation of Human Mesenchymal Stem Cells from Cord Tissue

N. Izaguirre‐Pérez¹, G. Ligero¹, P. A. Aguilar‐Solana¹, J. A. Carrillo‐Ávila¹, C. R. Rodriguez‐Reyes¹, I. Biunno², R. Aguilar‐Quesada¹, P. Catalina¹

¹Nodo de Coordinación, Biobanco del Sistema Sanitario Público de Andalucía, Granada, Spain, ²Isenet, Bresso‐Milano, Italy

Background: Long‐term cryopreservation of human mesenchymal stem cells (MSCs) is of fundamental importance for research as well as therapeutic purposes in the field of regenerative medicine. Current cryopreservation methods are based on cryoprotectant agents (CPAs), usually dimethylsulphoxide (DMSO), which has shown toxicity in clinical applications. Therefore, we propose an alternative trehalose‐based solution for cryopreservation in liquid nitrogen of MSCs from umbilical cord tissue (UC‐MSCs).

Methods: Cells viability, identity, chromosomal stability, proliferative and migration capacity, and stress response were assessed after cryostorage with trehalose as CPA at different concentrations and times, alone or in combination with ethylene glycol (EG). In addition, a second freezing cycle was performed in order to test the usefulness of this solution in daily routine.

Results: Although trehalose‐cryopreserved UC‐MSCs showed slightly lower viability compared with DMSO, cells maintained their functional properties and stability, obtaining the best results for 0.5M trehalose +10% EG. A second cycle of cryopreservation with this trehalose‐based solution slightly affected the migration of the cells with no additional impact on the viability. Overall, the gene expression analysis of HSPA1A, TP53, SOD2, BCL2, and BAX did not show significantly higher stress response for UC‐MSCs cryopreserved in 0.5M trehalose +10% EG compared to DMSO after both freezing cycles.

Conclusions: Trehalose‐based solution could be considered an effective and less toxic alternative to DMSO for cryopreservation in liquid nitrogen of UC‐MSCs.

PE‐07 Phosphatidylethanol in a Postmortem Human Brain Bank Cohort

C. C. Smith, M. Novelli, D. Maskey, J. Stevens, G. T. Sutherland

Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia

Background: The NSW Brain Tissue Resource Centre (NSWBTRC) in Australia facilitates the distribution of postmortem brain tissue to researchers globally, with a focus on alcohol use disorder studies. The accuracy of research outcomes using brain bank tissue relies significantly on precise case and control classification. Phosphatidylethanol (PEth) has emerged as a reliable biomarker for detecting alcohol use in the blood for up to four weeks following alcohol cessation, whereas traditional blood alcohol tests can only detect alcohol within a 12‐hour window. In this study, we aimed to identify PEth(16:0/18:1) in postmortem human brain tissue from a thoroughly characterised alcohol cohort sourced from the NSWBTRC, evaluating the effectiveness of this biomarker as a quantifiable classification tool.

Methods: Following established brain banking protocols, frozen postmortem brain tissue was collected and stored at ‐80°C. Case characterisation involved an exhaustive review of available medical records, input from next‐of‐kin surveys, comprehensive neuropathological and autopsy findings, and retrospective application of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnostic criteria. Our investigation involved 22 cases with a positive blood alcohol concentration (BAC) at autopsy and an additional 34 cases with a negative BAC at autopsy. We analysed cerebellar and meningeal samples for PEth(16:0/18:1) levels.

Results: Our results revealed detectable levels of PEth(16:0/18:1) in all cases with a positive BAC, with a robust correlation between PEth(16:0/18:1) levels and BAC. Notably, PEth(16:0/18:1) levels in cerebellar samples were approximately 3.5 times higher than in meningeal samples from the same case.

Conclusion: This study underscores the significance of PEth in human brain tissue as an indicator of recent alcohol use, emphasising its relevance in the accurate characterisation of cases in alcohol‐related research.

PE‐08 Double Chromogen‐Based Immunohistochemical Staining: An Efficient Approach for Utilising Extended Formalin‐Fixed Tissue Storage in Biobanks

D. Maskey, J. Stevens, M. Novelli, C. C. Smith, G. T. Sutherland

Pathology, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia

Background: The New South Wales Brain Tissue Resource Centre (BTRC) is a dedicated human brain bank that aims to provide top‐quality brain tissue for cutting‐edge neuroscience research spanning various conditions, ranging from alcohol use disorder to neurodegenerative disorders. However, the conventional practice of preserving brain tissue in formalin has posed challenges for immunofluorescent staining, primarily due to the formalin's tendency to create cross‐links between antigens, which can obscure epitopes of interest. Over time, prolonged formalin fixation can result in reduced antigen detection, particularly in the context of immunofluorescence (IF) staining. Additionally, researchers have encountered issues such as spectral bleeding, limitations in using multiple colours, autofluorescence, and cross‐reactivity when working with formalin‐fixed brain tissue. The purpose of the study was to test chromogen‐based double immunolabeling to negate the issue encountered with IF staining in long‐fixed.

Methods: Chromogenic immunostaining was carried out using a standard protocol on human brain tissues. Colocalization of antigens within the same cell explored using chromogens 3‐amino‐9‐ethylcarbazole (AEC) and 3,3,‐diaminobenzidine in a sequential staining procedure with IgG and HRP activity blocked by antigen retrieval treatment. AEC signal was eliminated by alcohol treatment.

Results: AEC is emerging as an ideal candidate for performing immunostaining on a single tissue section targeting two or more different antigens. Combination of same or different animals' antibodies did not affect the outcome negating the cross reactivity between the antibodies. The co‐localization of two antigens was also demonstrated with pseudo‐colour imaging that mimicked fluorescence staining.

Conclusions: This staining technique increases the utility of prolonged formalin‐fixed biobank tissue as it effectively addresses the challenges encountered with IF method on clinical samples such as biopsies; archival formalin‐fixed, paraffin‐embedded sections; and tissue microarrays.

PE‐09 Revising Freezing Method and Cryoprotectant Agents for Optimised Brain Tissue Quality

M. Novelli, C. C. Smith, D. Maskey, J. Stevens, G. T. Sutherland

Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia

Background: The NSW Brain Tissue Resource Centre is a human brain tissue bank focusing on alcohol use disorder and supplying tissue to researchers globally. As research methods advance, there is a need to update tissue preservation techniques to ensure their compatibility with emerging technologies. In the “omics” age of research, high tissue quality is more vital than ever, but traditional cryopreservation techniques often result in good RNA preservation but poor cytoarchitecture. We sought to optimise our tissue‐freezing method to improve cytoarchitecture whilst preserving molecular integrity. To preserve invaluable human brain tissue, we collaborated with our Veterinary Faculty to obtain sheep tissue for this work.

Methods: Sheep brains were held at 4°C until dissection at differing post‐mortem intervals (PMI). Brains were hemisected, and hemispheres to be frozen were hand sliced at approximately 5 mm coronally. Brain slices were placed on aluminium trays and held at 4°C during various treatments. Slices were treated with 0.9% saline, OCT, or 3% alginate in 1XPBS. The cryoprotectant agents were allowed to penetrate for 30 minutes before freezing. Tissue was frozen either by placing trays directly into the ‐80°C freezer to freeze, covering them in powdered dry ice, or pouring liquid nitrogen (LN2) over the slices. Slices were then trimmed and mounted in OCT before being sectioned on a cryostat at 10 mm; sections were fixed in 10% formalin for 15 minutes before standard hematoxylin and eosin staining. Slides were imaged on the Leica Aperio microscope and whole‐slide images were uploaded to a digital server. Images were analysed using Orbit machine learning‐based tissue quantification, and tissue cytoarchitecture was evaluated by calculating the percentage of void space within the tissue limits, averaged over three sites.

The average void space percentage and standard deviation across all sections were 24.80 ± 7.15. Freezing method and PMI both affected tissue quality, with a combination of LN2 and PMI yielding the best results (10.69% void space). Cryoprotectant agents had no significant impact on void space percentage.

Conclusions: While LN2 freezing yields optimal cytoarchitecture, challenges arise in freezing sections without macroscopic cracks. Further refinement of LN2 freezing methods holds the potential for achieving improved and consistent cytoarchitecture while preserving high RNA quality. Further optimisation work with LN2 is needed to refine this process.

PE‐10 Understanding the Experiences of Next of Kin Who Have Supported a Loved One with Brain Cancer to Donate Their Brain Post‐Mortem

C. Griffin^1,2, M. A. Carlson^1,2, M. M. Walker^1,2, J. Lynam^3,1, C. L. Paul^1,2

¹The University of Newcastle, Callaghan, New South Wales, Australia, ²Hunter Medical Research Institute, Newcastle, New South Wales, Australia, ³Medical Oncology, Calvary Mater Newcastle, Waratah, New South Wales, Australia

Background: Brain cancer is a devastating and incurable disease. With a median survival of approximately 14 months for stage 4 disease, patients have limited avenues for clinical hope. Post‐mortem brain donation is an invaluable gift to research, providing insight into pathogenesis as well as spatial and temporal heterogeneity, and as post‐mortem biobanking programs increase in number, so too does the need to understand the human experience associated with them.

Method:We interviewed 27 next‐of‐kin following the death of their loved one and subsequent donation to the Mark Hughes Foundation (MHF) Biobank. A thematic analysis based on the work of Braun and Clark was carried out on the transcribed, qualitative interviews and to date, data from the interviews have been analysed resulting in four preliminary themes.

Results: Themes included: 1) “We were just doing it, that's it!” – Brain donation is a straightforward decision grounded in altruism and pragmatism, 2) “I didn't feel helpless… because I could do this last thing for him” – 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 preliminary themes represent that brain donation is an instinctive decision, grounded in pragmatism, and that it provides a sense of comfort and anecdote to while assisting in making meaning for loved ones. We also obtained insight into areas in need of improvement; for example, the removal of the donor in the event of a home death and the role of the body bag.

Conclusion: Our data indicate that supporting a loved one to donate their brain is a positive experience providing a source of hope, empowerment, and purpose. Data indicating areas for consideration will be utilised to improve delivery of the program for future donors and their loved ones.

PE‐11 A Deeper Dive into Challenges Facing DNA Analysis in Human Urine in Context of Preanalytical Factors

A. Rao, L. Agrawal, S. Greytak, P. Guan, H. M. Moore

Biorepositories and Biospecimen Research Branch, National Cancer Institute, Bethesda, Maryland, United States

Statement of the Problem: The Biorepositories and Biospecimen Research Branch (BBRB) of the National Cancer Institute has a funding opportunity that supports extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in solid and liquid biopsies. As a part of this U01 grants program, Steering Committee meetings facilitate collaborative activities around common scientific challenges. In order to identify scientific challenges with collaborative themes critical to the investigators research and to provide concrete solutions, several Working Groups have been established. One such Working Group focuses on challenges facing analysis of DNA from biofluid biospecimens, particularly urine, with an emphasis on cancer and preanalytics.

Proposed Solution: Urine biospecimens have a heterogenous composition and can therefore present challenges when considering preanalytical factors. Preanalytical factors have not been extensively analyzed and characterized in urine, indicating the need to establish best practice guidelines to minimize the effects of preanalytical factors. Working Group leads work with group members to review and discuss topics of importance, define tasks, establish responsibilities, provide resources, and set both short and long‐term goals. As a part of addressing an immediate goal, the group is working on literature review and communicating their own experience and priorities from the laboratory to identify unanswered questions and gaps to produce Biospecimen Evidence‐Based Best Practices.

Conclusions: The aim of the described Working Group is to establish focus questions, objectives, and key deliverables to reach a consensus on best practices concerning DNA analysis in urine, the process or contents of which can provide a template for other biofluids as part of the Working Group's broader goals. To do this, group members are bringing together analysis of relevant literature and collective experience to inform evidence‐based best practices guidelines. Guidance is intended to support the development and execution of evidence‐based standard operating procedures for human urine biospecimen collection, processing, and storage to be used in conjunction with properly validated analytical assays.

PE‐12 Larege‐Scale Identity Testing of Human Biosamples for Biobanking

H. Kim, M. Lee, M. Hong, H. Yoo, M. Chung, B. Choi, H. Nam, J. Jeon

Division of Biobank, Korea Disease Control and Prevention Agency, Cheongju, Chungcheongbuk‐do, Korea (the Republic of)

When collecting human biospecimens for biobanking, there is a possibility that errors may occur during the handling, processing, or labeling steps. These errors provide researchers with inaccurate human bioresources, making them unusable for research. In order to prevent mis‐identification in advance, we introduced a identity testing procedure for biosamples to confirm whether the identifications of the samples are correct. The identity of human biosamples was confirmed in two steps: gender identification and genotype‐based genetic identification. As a result of gender identification of 15,000 participants, 50 biosamples (0.3%) exhibited gender‐mismatches. Of these gender mismatches, 36 mismatches were found to be errors in gender records, six mismatches errors in tube labels, and one mismatch an error in blood sampling. The other remaining seven mismatches were originated from bone marrow transplants (n = 3) and chromosomal abnormalities (n = 4) of donors and one blood sampling error. On the other hand, genotype‐based genetic identification testings showed 170 mis‐identifications (1.1%) of 15,000 biosamples. Of these genetic mis‐identifications, 166 mis‐identifications were generated in the experimental step during the DNA sequencing, six mis‐identifications during the genotyping calling and VCF file production. Our identity testing of large‐scale human biosamples, we confirmed that errors occur not only pre‐analytical phases of the collection and processing stages of human specimens, but also post‐analytical phases of the genomic data and VCF file production.

PE‐13 Quality Assessment of Human Blood Samples Stored for Long Term in Biobank

A. Moahamed, R. M. Ahmed, M. M. Saady, S. Aboelela, A. Ramadan, H. Fathi, A. Saleh

Research and biobank department, Shefa Al‐Orman Oncology Hospital, Luxor, New Tiba, Egypt

Introduction: Biobanks serve as a support infrastructure for the scientific community via providing a large number of high‐quality biological samples for definite downstream applications. Many recent developments in the field of human genetics and genomics would not have been possible without biobanks; biobanks' applications benefit in modern human genomics applications.

In addition, high‐quality human deoxyribonucleic acid (DNA) samples and associated information of individuals are mandatory for all molecular techniques.

We aim to analyse the quality indicators in DNA samples which had been derived and stored 3 years ago in the Shefa Al‐Orman Oncology Hospital (SOH) biobank to ensure correct collection, storage, and use of biological material after 2 years of storage in a ‐80°C freezer.

Methods: Our study was conducted to analyze the quality indicators in DNA samples which had been derived and stored three years ago in the SOH biobank.

Extraction of DNA was done with the QIAamp DNA Mini Kit (Qiagen, Hilden, Germany), as described in the kit's manual. The study was conducted in upper Egypt in the Research department of SOH. Where a total of 1,670 blood samples obtained from cancer patients (n = 1670) and DNA was isolated manually from the buffy coat using QIAamp DNA Mini kit (Qiagen, Hilden, Germany), according to the manufacturer's instructions, the DNA was eluted in 200 μL buffer. DNA was quantified by spectrophotometric (by Multi Skan Sky instrument) where DNA quality was detected at a 260/280 ratio.

Result: The 260/280 purity ratio was estimated for each DNA sample, with the median value 1.76 while DNA integrity was obtained at wavelength 260 nm with the median value 43.8.

Conclusion: Determination of the exact DNA concentration in the sample of isolated DNA is necessary. This step is important because the reaction conditions depend on the initial DNA concentration.

Finally, SOH Biobank provides prominent examples of such data integration.

PE‐14 The Nngwe Project and Biobanking: An Initiative that Translates to Patient Care

A. C. Swanepoel¹, E. H. Conradie¹, E. M. Honey², M. Dercksen¹, B. C. Voster¹

¹Centre for Human Metabolomics, North‐West University, Potchefstroom, North‐West Province, South Africa, ²Department Biochemistry, Genetics and Microbiology, Faculty of Natural and Agricultural Science, University of Pretoria, Pretoria, Gauteng, South Africa

Statement of the Problem: Rare diseases (RDs) refer to nearly 7,000 genetic conditions that each affect less than one in 2,000 individuals. It is estimated that one in 15 South Africans are affected by a RD, making them cumulatively common. It is unfortunate that RDs have been neglected on many fronts, with the lack of diagnostic services impeding proper patient care. Internationally, healthcare has shifted its focus to aggressively address the needs of RD patients while at the same time utilizing the subsequent bio‐economical advances. Diagnosis is the first step in this process. Although the infrastructure and expertise are available to some extent, the needs of RD patients have only been addressed through scattered efforts. Many RD patients, mostly young children, remain marginalised and largely forgotten.

Proposed Solution: The Nngwe project is the rare undiagnosed diseases initiative hosted at the Centre for Human Metabolomics (CHM) at North‐West University (NWU), which intends to establish a collaborative and integrated omics diagnostic programme focusing on rapid diagnosis and characterisation of RD patients. The Nngwe project is the first of its kind in (South) Africa and aspires to establish a network, consisting of many entities, that will work together to change the life of one patient, living with a rare undiagnosed disease, at a time.

The Nngwe project is closely related to the recently established CHM Biobank, which specializes in storage of biological samples from RD patients. The vital role of the Nngwe project in (South) Africa is illustrated by the recent diagnosis of UNC80 deficiency in two young South African children.

Two paediatric siblings, a brother and sister, presented to the genetics clinic where extensive biochemical and genetic testing and imaging of the brain revealed no aetiology which could explain the phenotype. The diagnostic odyssey of 7 years, however, ended when a rare, likely pathogenic, bi‐allelic homozygous variant (UNC80:c.5757delC) in the UNC80 gene via whole exome sequencing (WES) of both children was identified.

Conclusion: Based on this case and various other, an integrative omics approach, as outlined and steered by the Nngwe project in conjunction with the CHM biobank, will be an essential initiative that translates to improved diagnosis and subsequent patient care in (South) Africa.

PE‐15 In Pursuit of Perfect Prostate Cancer Procurement: A Biobank's Journey

C. Brown, K. Frankey, S. J. McCall

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

Statement of Problem: The incidence of prostate cancer continues to increase in the United States, yet providers still lack a full understanding of the genetic, environmental, and physical factors that can alter the prevalence and severity of the disease. To address this issue and advance treatment options for patients, researchers are focusing their studies on the molecular drivers of prostate cancer. To carry out their experiments, investigators require high‐quality tissue samples from prostatectomies, but obtaining these samples is challenging. Unfortunately, most biobanks struggle to rapidly distribute confirmed fresh or frozen tumor and uninvolved tissue samples due to the notorious difficulty in identifying prostate cancer in gross tissue, even by experienced pathologists' assistants. Without accurate samples from biobanks, researchers will struggle to make advancements in this field.

Proposed Solution: The Duke University BioRepository & Precision Pathology Center (BRPC), which serves as the Southern Division of the National Cancer Institute's Cooperative Human Tissue Network (CHTN‐SD), has collaborated with clinical pathologist assistants and expert prostate pathologists to create a frozen prostate protocol. In this protocol, the pathologists' assistant sections the prostate whole and designates two slices for research. Each research slice is further bisected—one of the halves is frozen in cutting medium and used to create slides for review by a prostate pathologist. This immediate “frozen section” analysis allows for the histologic diagnosis of the matching mirror‐face fresh tissue to be known, facilitating delivery of confirmed fresh prostate cancer tissue to investigators.

Conclusions: The frozen prostate protocol at BRPC is now one of the prostate cancer procurement tools that has led to the distribution of over 8,000 fresh, frozen and formalin‐fixed, histologically‐verified prostate tissue samples to investigators. The protocol allows for the immediate distribution of verified fresh or frozen tumor and normal samples to investigators, but it is a labor‐intensive process that can result in a long cold ischemic time. The BRPC/CHTN‐SD will continue to improve the prostate cancer tissue procurement process to best serve the needs of investigators as they work to develop targeted therapies that can improve patient outcomes in the future.

PE‐16 The Future of Brain Banking

G. T. Sutherland¹, J. Stevens², D. Maskey², M. Novelli², C. C. Smith², A. Rush³

¹Neuroscience, The University of Sydney, Sydney, New South Wales, Australia, ²New South Wales Brain Tissue Resource Centre, The University of Sydney, Camperdown, New South Wales, Australia, ³Menzies Centre for Health Policy and Economics, The University of Sydney, Camperdown, New South Wales, Australia

Statement of the Problem: Post‐mortem human brain banks are an important research infrastructure for research into neurological and neuropsychiatric diseases. Brain banks have traditionally grown out of neuropathology services with a fundamental role of providing a definite diagnosis. Brain tissue is also used for corroborating and validating mechanistic findings from cell and animal models; however, somewhat paradoxically, human tissue is not considered suitable for mechanistic studies per se. Other issues with human tissue include that traditional cryopreservation techniques result in high‐quality RNA preservation but poor cytoarchitecture, a disconnection from clinical research, and that the size of the human brain makes it difficult to scale up assays to capture a global view of pathology. The NSW Brain Tissue Resource Centre is working toward optimising processes and non‐traditional collaborations to solve these issues.

Proposed Solutions: Tissue microarrays (many tissue cores, one block) in combination with multiplex imaging and automated image analysis provide an optimal method for capturing global trends without compromising sampling accuracy. When human tissue is used for mechanistic studies, it is increasingly for single‐cell technologies including the latest spatial biology tools. The advent of spatial biology means that spatial and molecular data can be captured in the same section from the one side of the brain. Improving cytoarchitecture through new rapid freezing protocols can enable the application of spatial platforms to human brain tissue. Brain banks can contribute actively to clinical research by banking plasma, DNA, omics, and neuroimaging data prior to tissue collection. Brain banks can and should collaborate with the wider biobanking community to build more comprehensive pictures between seemingly distinct brain and systemic diseases. Moreover, brain banks should explore scaling up by miniaturisation of tissue collections and data curation to take advantage of opportunities provided by large cohort studies like UK Biobank and All of Us.

Conclusions: Brain banks provide a valuable resource for the research community. They need to work to stay relevant, keep up to date with technology, and think outside the (square) brain to get most of the tissue collected for patients, their families, and the communities that they serve.

PE‐17 Gut and Oral Microbiome Sample Collection in the Cancer Prevention Study‐3 Cohort

C. Lichtman, E. Bain, D. Millard, R. Hodge, A. Patel, C. Um

American Cancer Society, Atlanta, Georgia, United States

Background: The American Cancer Society's Cancer Prevention Study‐3 (CPS‐3) is a prospective cohort study of cancer incidence and mortality. At enrollment (2006‐13), consented participants completed a survey and provided a blood sample. Ongoing participation includes triennial surveys (starting in 2015) and the opportunity to participate in associated substudies. Samples from large, prospective cohort studies are needed to understand how the gut and oral microbiomes are related to lifestyle and environmental factors and with cancer risk and outcomes. Herein, we describe methods and baseline characteristics for the CPS‐3 Microbiome Substudy.

Methods: In 2020‐21, participants were invited to enroll in the CPS‐3 Microbiome Substudy and provide a single stool sample, whereas enrollees in 2022‐23 collected both a stool and a saliva sample.

The eligibility criteria included limits on recent 1) antibiotic/antiviral use, 2) rectal bleeding or positive fecal occult blood tests, and 3) colonoscopy/procedures requiring bowel preparation as well as gum disease for those enrolling in 2022‐23. Consented participants were mailed a collection kit containing all necessary supplies for sample collection. Stool samples were collected using Immunostics, Inc. fecal occult blood test cards and saliva samples were collected using OMNIgene Oral OM‐501 tubes from DNA Genotek. Sample(s) were returned to the American Cancer Society biorepository via UPS/FedEx at ambient temperature where they were processed within 24 hours of receipt and put into ‐80°C ultra‐low‐temperature freezers. Participants also completed a corresponding online questionnaire within 24 hours of sample collection.

Results: Nearly 75,000 CPS‐3 participants were invited to the CPS‐3 Microbiome Substudy, and approximately 21% consented to participate. Of those who consented, ∼86% successfully completed the sample collection(s) and accompanying survey. The mean age of participants who completed the study was 60 years (range 37‐83). Participants resided in all regions of the U.S., 77% were women, and 11% were non‐white (Latino, Asian/Pacific Islander, Black, American Indian, Alaska Native).

Conclusions: These results show the process and response rates in collecting gut and oral microbiome samples in the CPS‐3 cohort. The diversity of participant ages, race/ethnicities, and geography will enable a wide range of research to improve our understanding of the gut and oral microbiomes and cancer.

PE‐18 TP53 R248L in Head and Neck Squamous Cell Carcinomas: Absolute Quantification of DNA from Formalin‐Fixed Paraffin‐Embedded Samples Using dPCR

S. Kaushal, J. Namkoong, D. Ko, P. Sharma, J. Rull, B. Wishart, A. Garcia, E. Masmila, A. Molinolo

Moores Cancer Center Biorepository, University of California San Diego, La Jolla, California, United States

Background: Formalin‐fixed paraffin‐embedded (FFPE) tissues are widely available. However, extracted nucleic acids from FFPE tissues are degraded, which affects DNA quality, making them unsuitable for downstream assays like DNA sequencing. Illumina standards require DNA samples to pass certain quality control thresholds, including having a single clear band on an agarose gel, a minimum DNA concentration of 20 ng/μl, a 260/280 absorbance ratio greater than 1.5, and a fragment size greater than 50 kB in length for sequencing. However, degraded DNA from FFPE samples that fail to meet these standards can be used to quantify mutations using QIAcuity‐digital PCR. In this study, we demonstrated this technique by detecting the TP53 R248L mutation in squamous cell carcinoma of head and neck cancer (HNSCC).

Methods: The study collected 17 FFPE block samples from consented subjects with HNSCC; the status of p53 mutations was identified from pathology (immunohistochemistry) or sequencing reports, while p53 expression was identified by immunochemistry and evaluated by a pathologist as either positive or negative. The DNA was extracted from the FFPE tissue samples using the QIACube Connect with the QIAamp DNA FFPE tissue kit. Quality assurance was performed using an Agilent Tapestation 4200 for DNA integrity and Q‐bit assay for DNA concentration. All extracted DNA samples were evaluated for TP53 R248L mutations using the QIAcuity One, a digital PCR (dPCR) system.

Results and Discussions: Pathological evaluation of the samples by immunohistochemical assay found inconsistencies in seven out of 17 blocks when compared to medical records (pathology reports). DNA integrity number values for the extracted DNA showed an average of 3.1, ranging from 2.1 to 4.9. Wildtype p53 was present in all cases as per dPCR data. The QIAcuity dPCR system data was recorded in a binary fashion at 200 milliseconds exposure; TP53 R248L mutations in 14 cases out of 17 were detected, ranging incidences of mutation from one to eight per case. When exposed to 500 milliseconds to increase the sensitivity of mutation detection, all 17 samples were positive, ranging from two to 21 incidences per sample of TP53 R248L mutations. This demonstrates that fragmented, low‐quality DNA is a significant opportunity for detecting mutations such as TP53 R248L by utilizing dPCR.

PE‐19 Biobanking Challenge: The Critical Evaluation of Potentially Valuable Archival Dried Blood Spot (DBS) Collections from Uganda

R. Zhang, P. Bracci, A. Leong, C. Rapp, M. McGrath

The AIDS and Cancer Specimen Resource, University of California San Francisco, San Francisco, California, United States

Background: The AIDS and Cancer Specimen Resource (ACSR) obtained dried blood spots (DBS) from persons living with HIV (PLWH) in Uganda who were initiating anti‐retroviral therapy (ART) with/without confirmed Kaposi's Sarcoma (KS). Both epidemiologic studies collected blood from participants at baseline prior to ART and for up to 5 years post ART. The purpose of the current study was to determine the quality of archival DBS samples that were stored variably at room temperature or ‐80°C compared with plasma collected from the same patients at the same time and stored at ‐80°C.

Methods: Paired EDTA blood and DBS (50μL/spot) collected between 2007‐2014 were shipped to ACSR for long‐term storage. Twenty‐four DBS samples obtained in 2011 (12 ARKS & 12 UARTO participants) were evaluated. DNA was isolated using QIAamp DNA Investigator kit and protein was extracted using D‐PBS with protease inhibitor and surfactant. DNA quality was evaluated by Qubit & Bioanalyzer. Protein levels were determined by Pierce BCA Protein Assay Kit. Sixteen biomarkers for DBS extractions and paired plasma were evaluated by AssayGate Inc. Wilcoxon test and linear regression were used for data analysis. Log transformations were applied to non‐normally distributed data, a two‐sided p‐value <0.05 was considered statistically significant.

Results: High‐molecular‐weight DNA was obtained from DBS, yielding 57‐217ng from 1/3 of a DBS. Protein and DNA levels were directly related from the same DBS (p = 0.01) and higher in PLWH with KS (ARKS) than PLWH without KS (UARTO) (p = 0.02). Compared to UARTO, levels of MIG, RANTES, INF‐g, and IL‐1b were elevated in ARKS DBS extraction (p < 0.05) whereas MIG, MCP‐1, TNF‐a, IL‐2, IL‐8, and IL‐10 were higher in ARKS plasma (p < 0.04). Notably, there was a direct relationship of levels of MIG, RANTES, CRP, INF‐g, IL‐8, and IL‐17 between DBS extraction and paired plasma (p < 0.04). IL‐4, IL‐13, and IL‐12p70 were too low for detection in 1/3 or more samples in both DBS and plasma specimens.

Conclusion: The ACSR provides high‐quality specimens at no cost to HIV researchers studying cancer. KS is still a leading cause of death in Africa so having the outcome‐associated ARKS and control UARTO study specimens available for pathogenesis related research is invaluable. The validation of the DBS collection expands their availability for studies of both DNA and proteins even from a decade old DBS collection.

PE‐20 Nucleic Acids Storage at Different Temperature Range and Different Storage Solutions

T. Moshoma^1,2, E. S. Mayne³, M. Gededzha⁴, N. Mampeule¹

¹Immunology, University of the Witwatersrand Johannesburg, Johannesburg, Gauteng, South Africa, ²Molecular, Wits Diagnostic Hub, Johannesburg, Gauteng, South Africa, ³Immunology, University of Cape Town Department of Medicine, Cape Town, Western Cape, South Africa, ⁴Sefako Makgatho Health Sciences University Faculty of Health Sciences, Pretoria, Gauteng, South Africa

Background: Temperature and storage conditions can impact nucleic acid integrity which is critical for multiple diagnostic and medical research applications including infectious disease and cancer diagnosis. Although storage and shipment of extracted nucleic acids on dry ice preserves integrity, it is expensive and in low‐ and middle‐income countries may limit sample sharing. The biorepository at Wits Diagnostic Innovation Hub was established to store samples for the human health and heredity (H3A) project which studies genetic predictors of disease. The biorepository undertook a study to investigate innovative storage solutions for nucleic acids including the feasibility of storage of both DNA and RNA at higher temperatures for prolonged periods.

Method: Total nucleic acids were extracted from 17 EDTA samples sent for routine analysis. Aliquots were stored using different storage solutions at a range of temperatures for 24 and 96 hours, 30 days and 90 days. Post‐storage nucleic acid quality was assessed using gel electrophoresis, nanodrop spectrophotometry, and RNA and DNA integrity numbers (D and DIN – Agilent technologies). Human Leukocyte Antigen (HLA sequencing) was performed on four samples stored for 90 days.

Results: There was no notable difference in RNA Nanodrop concentration and quality between 32 RNA aliquots stored in adsorption beads and 40 stored in RNA storage solution for a 30‐day period (P = 0.3300). Both DNA and RNA Nanodrop concentration and quality declined for aliquots stored at 40‐50°C for all time periods, indicating nucleic acid instability at high temperatures. DNA gel electrophoresis showed fainter bands in aliquots stored at 40‐50°C for 30 days. RNA aliquots stored at 50°C for 96 demonstrated high fragmentation (a RIN value of <4.5), while those stored at RT, 2‐8°C, and ‐80°C for 96 hours showed less fragmentation (RIN values >6.0). Three of four DNA aliquots stored at RT for more than 90 days could be successfully sequenced with the fourth showing incomplete data.

Conclusion: Nucleic acid samples stored at controlled ambient temperature maintained high quality and concentration, showing potential for downstream applications like sequencing. Higher temperatures impacted RNA and DNA integrity especially for long periods. This suggests that ambient temperature storage of RNA and DNA is feasible.

PF‐01 Bridging the Gap: Biobanking's Vital Role in Advancing Clinical Studies

K. Pryce¹, Y. Wang¹, X. Wang¹, Y. Rhou², D. Pasupathy²

¹Scientific Platform ‐ Biobank, Westmead Institute for Medical Research, Westmead, New South Wales, Australia, ²Faculty of Medicine and Health, University of Sydney, Reproduction and Perinatal Centre, Westmead, NSW, Australia

The intersection of biobanking and clinical studies is critical in catalyzing breakthroughs in clinical studies. Biobanking plays a multifaceted role in advancing clinical studies, by facilitating sample collection/storage, ensuring quality control of collected specimens, and maintaining and managing associated clinical data. While Biobanks are the vessels for invaluable biological specimens and associated data, clinical studies provide eye‐opening insights into the mechanisms that drive diseases, treatment possibilities, and prevention.

Westmead Biobank has been collaborating with the PROMOTE (Improving maternal & PeRinatal Outcome aMongst wOmen with and without obesity) team at Westmead Hospital and the Reproduction and Perinatal Centre since 2022. Obesity during pregnancy, together with baseline sociodemographic, clinical, and lifestyle factors such as an age, ethnicity, sedentary lifestyle, dietary quality, and mood compound cardiometabolic risk and determine perinatal outcomes and risk of lifelong cardiometabolic disease for both mother and offspring. However, previous trials of dietary and exercise interventions failed to demonstrate meaningful improvement in the outcomes. One limitation of these trials is the lack of sub‐stratification. PROMOTE seeks to prospectively identify single and interactions between multiple factors, including cardiometabolic biomarkers, to define groups at greatest risk of adverse outcomes [JR(SL1] for targeted intervention. Participants are recruited in early pregnancy <16 weeks gestation. Specimens include samples of maternal blood during pregnancy (up to three collections per participant) and/or umbilical cord blood after birth. Westmead Biobank was brought on board to provide services including processing of samples, division and distribution of samples into aliquots, storage of samples, eventual performance of tests, reporting of results, and, after the conclusion of the study, disposal or transfer of specimens. Westmead Biobank has successfully processed and stored samples from ∼244 participants for PROMOTE = , which include whole blood, plasma, serum, and peripheral blood mononuclear cells.

In summary, the role of biobanking in clinical studies is pivotal. Biobanks serve as the cornerstone of biomedical research by providing high‐quality biospecimens and associated data, enabling scientists and clinicians to make ground‐breaking discoveries, improve patient care, and advance our understanding of diseases and treatments.

PF‐02 Role of Biobank Infrastructures in Developing and Validating Bio‐Detection Systems

P. Rahi¹, R. Artus¹, E. Roux¹, A. Zayoud², H. Laude², D. Clermont¹, M. Gugger¹, F. Betsou¹, M. L. Ferrari¹

¹Biological Resource Center of Institut Pasteur, Institut Pasteur, Paris, Île‐de‐France, France, ²ICAReB‐Clin, Paris, France

Statement of the Problem: The global impact of the recent COVID‐19 pandemic has underscored the critical role of biosecurity measures in safeguarding public health. The imperative for robust microbial agent detection systems for surveillance purposes has become more pronounced with the emergence of advanced molecular engineering tools, which may lead to inadvertent creation of more potent pathogens, and the risk of accidents within biological laboratories. The dynamic nature of wildlife ecosystems and ecological competition therein may also expose both humans and domesticated animals to novel and previously unidentified pathogens. Finally, intentional misuse of scientific knowledge may lead to propagation of harmful pathogens.

In response to these challenges, there is an urgent need for the development of both on‐field and highly accurate bio‐detection systems.

Proposed Solution: The development and implementation of such systems hinges on the availability of standardized reference materials and robust validation procedures, which can be provided by biobanks. Biobanks are engaged in the collection, preservation, and dissemination of authenticated biological specimens. In this study, authenticated and quality‐controlled microbial resources, as well as clinical collections of exhaled breath condensates (EBC) linked to pertinent health information, were used in the validation steps of the development of a digital holographic microscopy bio‐detection system. The microbial biospecimens were used to: feed a library of images to train artificial intelligence algorithms; test, adjust, and compare two prototypes and reference imaging systems; improve the image acquisition; set up in vitro the environmental sampling system. The EBC from healthy and COVID‐19 ill patients were used to validate the capacity of the system in the bio‐detection of SARS‐CoV2 virus.

Conclusions: By providing access to a comprehensive array of specimens, along with the necessary infrastructure and expertise, biobanks become strategic contributors to the production and procurement of biological materials under accreditation standards. Appropriate processing and analytical methods are used to produce, authenticate, quantify, genotype, and phenotype these materials, leveraging the biobank's scientific and technical expertise. These materials, in turn, serve as indispensable reference points for the development of bio‐detection systems and facilitate comparative studies to validate detection methods.

PF‐03 The Unique Role of Scientific Collections: Infrastructure Generating Benefits, Serving Diverse Agency Missions

M. Henderson¹, D. E. Schindel³, D. DiEuliis², B. Geyman⁵, on behalf of the IWGSC⁴

¹Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, United States, ²National Defense University, Department of Defense, Washington, District of Columbia, United States, ³Smithsonian National Museum of Natural History Research and Collections, Washington, District of Columbia, United States, ⁴US Government, Interagency Working Group on Scientific Collections, Washington, District of Columbia, United States, ⁵US Geological Survey, Reston, Virginia, United States

Statement of the Problem: While it is understood that there is tremendous research value in scientific collections, the challenges of parlaying that research value into financial and institutional support are almost ubiquitously shared. One of the earliest accomplishments of the U.S. Interagency Working Group on Scientific Collections (IWGSC), established in 2006, was to survey the U.S. federal government; take stock of existing federal infrastructure on collections; and further, to articulate the critical scientific, technical, environmental, societal, and many other sectors throughout the country that benefit from collections. These findings were published in the first report of its kind, entitled “Scientific Collections: Mission‐Critical Infrastructure for Federal Science Agencies.” However, even after a decade of progress, the authors recognize the changes in the scientific landscape which have shaped the collections field, such as emerging technologies and global challenges.

Proposed Solution: In a new 2023 report, “The Unique Role of Scientific Collections: Infrastructure Generating Benefits, Serving Diverse Agency Missions,” the IWGSC details important achievements, new pursuits, and continued due diligence on behalf of the U.S. government to ensure the protection, accountability, and stewardship of federal investments in collections to benefit the country. Although the report focuses on U.S. federal collections because of the scope of IWGSC, the principles apply to most collections within the scope of ISBER, and we hope that our model inspires others.

Conclusions: In undertaking a refreshed endeavor to catalogue the accomplishments of scientific collections in the 21st century, the IWGSC finds the need for collections' stewardship continues to be exceedingly important. The potential research opportunities for items in collections are as diverse as the users and will only continue to grow with evolving and advancing technologies. The value of scientific collections – culturally, scientifically, financially – remains high and potentially without limit.

PF‐04 Global Health Emergencies Foster the Evolution of Biological Research Centers

R. L. Bradford

Federal Solutions, American Type Culture Collection, Manassas, Virginia, United States

For 95 years, ATCC has been compelled by its deep‐rooted mission to improve global public health through advancements in science. At its inception in the 1920s, ATCC was regarded as simply a microbe culture collection, a repository of microorganisms scientists could draw from to conduct their research to make discoveries. Today, ATCC provides the world's leading scientists with the largest and most diverse collections of biological materials, including microbe products, cell products, molecular genomics tools, and derivative reagents. As highlighted during the pandemic, having in‐country access to key cell lines, pathogens, and reagents is essential for scientific research, innovation, and breakthrough technologies. The pandemic fostered greater global collaborations to expand access to strains, information, and biological standards to promote reproducible science. The pandemic also elucidated challenges in some countries without centralized bioresource centers, including import/export regulations, in‐country production of high‐quality biomaterials, costs for transport, and supply chain disruptions. The benefits of in‐country bioresource centers include 1) establishment of depositories for cells/microorganisms and key biomaterial needed for reproducible science; 2) manufacturing capability to rapid supply of high‐quality, characterized and authenticated cell lines/organisms/reagents for innovation in medical countermeasure development; and 3) facilitation of the development and validation of biotechnological products and processes which contributes to the growth and competitiveness of biotechnology and related industries in the country and globally. To that end, ATCC Federal Solutions is exploring opportunities to establish a bioresource center with operations in Australia to support Australian government‐sponsored, academic, and bio‐pharmaceutical life science research and create an ATCC biomanufacturing base of operations within the Asia‐Pacific region. This center will promote scientific discoveries that provide biological standards, ease of use, regulatory oversight, and a global reach in Australia.

PG‐01 WITHDRAWN

PG‐02 Barriers to Cancer Research Participation among New Mainers

A. C. Breggia

Center for Applied Science and Technology, MaineHealth, Portland, Maine, United States

Aim: We examined barriers for New Mainers in participating in the Cancer Moonshot Biobank and other cancer genomics and clinical trials research. It includes a critical focus on barriers to initial diagnosis and access to specialist cancer care, which are prerequisites for research involvement.

Background: Cancer research advances cancer treatments, and participation in research may open new treatment options and enhance patient care. Unfortunately, new Americans are often underrepresented in studies which results in disparities in healthcare outcomes for immigrant communities. Furthermore, underrepresentation may reflect barriers to diagnosis or care, lowering the likelihood a patient will have an opportunity to participate.

Methods: Based on theoretical sampling, we interviewed key informants with relevant information on Maine cancer care or research and on immigrant healthcare, to include oncologists, research coordinators, community health workers, and others. We used their accounts to construct a map of pathways to cancer care and research, and then identified barriers along that pathway.

Results: New Mainers face barriers throughout the cancer care and research pathway. Shortages of providers and patient beliefs about preventive medicine hinder screening and early diagnosis. Accessing treatment while maintaining employment is challenging due to coverage gaps and employment policies. Despite a desire to include New Mainers, research staff and oncologists may not inform them about studies, owing to lack of translated materials, misconceptions about eligibility, and limited time during office visits.

Conclusions: This study highlights how economic determinants of health and other aspects of the New Mainer experience affect cancer diagnosis, treatment, and research participation. Structural issues of access, including provider shortages and coverage gaps, must be addressed to improve immigrant participation. Health systems should clarify policies around trial‐related materials translation and consent. Educational programs, use of cultural ambassadors, and collaborations with immigrant‐serving organizations can build trust, raise awareness, and overcome barriers.

PG‐03 Impact of COVID‐19 Pandemic on Willingness to Participate in the McCain GU Biobank

H. Wagner, N. Recio, C. Pejkovic, M. Ghany, T. Sildva, A. Hasan, L. Weiss, J. G. Cockburn, S. Chowdhary, N. Fleshner

University Health Network, Toronto, Ontario, Canada

Background: The COVID‐19 pandemic has impacted medical research in several ways, including the need to implement infection‐prevention standard operating procedures and address a decrease in consent rates. The pandemic revealed some distrust in healthcare systems and reluctance to participate in research. Health‐focused biobanks rely on strong participant engagement to obtain representative and robust specimens for research. As such, biorepositories must balance pandemic‐related challenges with their responsibilities to obtain, curate, and deliver high‐quality specimens. Investigating how perspectives about scientific research have changed after the COVID‐19 pandemic will provide an opportunity to identify specific concerns about participation.

Methods: A questionnaire was developed to identify perspectives of existing participants of the McCain GU Biobank (MGB) at the University Health Network in Toronto, Ontario. Participants were asked for their education, employment, and COVID‐19 exposure. The survey included 14 face‐validated items about attitudes towards research after the pandemic, logistical preferences for research participation, and source of information and trust in research. Survey response data was evaluated for internal reliability using Cronbach's α and distribution of responses was assessed for each item.

Results: 151 participants completed the survey, with an age range of 30‐96 years; they were predominantly male (97%) and had a history of prostate (65%), other GU cancer (33%), or no GU cancer (2%). The COVID‐19 pandemic had mostly positive or neutral impacts on attitudes toward scientific research. The majority (95%) experienced positive or no change in research opinions and remained willing to speak about (87%) and participate in (98%) research. Importantly, 88% believed that participating in research does not increase risk for COVID‐19. Respondents primarily relied on public health and news outlets for information and prefer in‐person healthcare services. Concerns were raised about a reduction in access to healthcare services due to the pandemic, though many were willing to participate in scientific research if it could be done from home.

Conclusions: This study verifies the continued support of participants in their dedication to research, despite challenges faced during the COVID‐19 pandemic. Future studies will assess perceptions in a population of those not actively enrolled in a biobank to explore opportunities to increase recruitment.

PG‐04 Shaping the Future of Biobanking in Ukraine: From Challenges to Roadmap

O. Sulaieva^2,1, R. Semikov^2,3, O. Gaidamak², Y. Zakharash^2,4

¹Medical Laboratory CSD, Kyiv, NA, Ukraine, ²Ukrainian Association of Research Biobanks, Kyiv, Ukraine, ³Audabon Bioscience, Kyiv, Ukraine, ⁴Nacional'nij medicnij universitet imeni O O Bohomol'ca, Kiiv, Kiïv, Ukraine

Statement of the Problem: Developing a biobank network in Ukraine is essential to fostering genomic research and precision medicine. Lack of legal and ethical governance and gaps in sample quality assurance in conjunction with low awareness about biobank purposes and operations are the principal threats to fostering biobanks in Ukraine. These affect stakeholders` perceptions, community trust, and public engagement.

Proposed Solution: To facilitate local and international networking, enhance research activities, stimulate harmonization of legal and ethical guidelines, and ensure standardization of biospecimen quality, the group of researchers, physicians, lawyers, laboratory professionals, managers, and biobankers joined their efforts and founded the Ukrainian Association of Research Biobanks (UARB). Becoming a part of a working group at the Ministry of Health of Ukraine, UACR contributed to developing national guidelines for biospecimen‐related research in compliance with international ethical recommendations to safeguard participants' rights, welfare, and privacy. The developed draft of national guidelines also highlighted the measures on standardization of the preanalytical phase of biosamples‐driven research and quality oversight enforcing the culture of high‐quality samples for biobanking in Ukraine. Addressing the call for increasing awareness and recognition of biobanking as a tool for driving precision medicine, UARB also developed a roadmap that is focused on facilitating networking between the private and academic sectors, as well as educational events for physicians and patient communities for building trust and providing Ukrainian physicians and laboratory professionals with essential knowledge about biobanking activities and their role in precision medicine.

Conclusions: Biobanking in Ukraine faces numerous challenges and barriers. Approval of national guidelines consistent with international ethical recommendations for safeguarding participants' rights and ensuring sample and data integrity are essential for unlocking biobanking progress in Ukraine. Additionally, efforts to educate and engage physicians and patient communities are crucial for fostering biobanking activities and precision medicine in Ukraine.

PG‐05 Evaluating Deficiencies of Tissue Bank Consent Taking and Documentation

B. Soh, E. Thit, L. Yue, T. Chang

SingHealth Tissue Repository, SingHealth Group, Singapore, Singapore, Singapore

Statement of Problem: In Singapore, under the Human Biomedical Research Act 2015, appropriate consent must be obtained for conduct of human biomedical research including the handling and use of human tissue for research. At the time of consent taking, the consent form must be properly completed, stating the donor's decision for tissue donation clearly. It must also be signed by the donor before any tissue can be banked or used for future research.

At the SingHealth Tissue Repository (STR), we not uncommonly encounter deficiencies in the consent‐taking process. Consent is usually obtained from the donor by healthcare professionals such as doctors, nurses, and research team members. Improperly obtained consent documentation results in a citation during a compliance audit.

Common deficiencies on the consent form include no indication of the specific surgical procedure and tissue site, no indication of whether the left or right thumbprint was obtained, improper or incomplete recording of donor name and date, and the inclusion of donor identifiers (apart from name) which is prohibited by personal data protection regulations. Deficiencies in the consent documentation process may raise concerns on the validity of the purported consent obtained.

Proposed Solution: To address this, STR implemented a practice of tabulation of consent deficiencies for tracking purposes, regular review of consent deficiencies to identify the root cause and rectify deficiencies and providing guidance to consent takers on proper consent form documentation. During such evaluation, STR identified a category of minor deficiencies which do not raise contention on the validity of the consent obtained; such minor deficiencies do not necessarily obviate the validity of the consent obtained.

Conclusion: Common consent taking and documentation deficiencies may be a daily operational and regulatory‐compliance challenge for a tissue bank. Tissue banks should explore solutions to address the consent deficiency issues. The implementation of electronic consent taking in the future may address some of such issues for banks with the capability of implementing electronic consent taking.

PG‐06 Enrollment and Patient Preferences in Participation in a Pediatric Ophthalmology Biobank

R. Noronha¹, K. Flegg¹, A. Mallipatna^1,2, 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

Background: Biobanking holds potential to transform poor outcomes of pediatric eye conditions. A pediatric ophthalmology biobank was developed at The Hospital for Sick Children (Toronto, Canada) to house a large number of specimens and associated data. We aimed to describe the enrollment and preferences of participants in this novel biobank.

Methods: Eligible patients included those diagnosed with an ophthalmic condition who, due to standard of care, had a specimen extracted not required for clinical purposes, or underwent significant imaging.

A broad informed consent model was utilized, allowing storage of specimens and data for future use in unspecified research; patients were provided with the option to opt‐out of specific research components. With patient/substitute‐decision‐maker informed consent, specimens and associated clinical data were collected and stored.

Results: From June 2020 through October 2023, 132 patients were approached for study participation, and 124 provided written informed consent (94% consent rate). Of consented participants: 70% agreed to research by industry, 94% to genome sequencing research, 96% to development of organoids/cell lines, 94% wished to be informed of carrier status, and 90% agreed to future research contact. Specimens were contributed by 52% of participants. Participants covered 15 diagnoses (retinoblastoma, cataract, Coat's disease, juxtapapillary retinal capillary haemangioblastoma, angiolymphoid hyperplasia with eosinophilia, familial exudative vitreo‐retinopathy, retinal astrocytic hamartoma, pilocytic astrocytoma, esotropia, rhabdomyosarcoma, non‐Langerhans histiocytic infiltrate, Langerhans cell histiocytosis, parasitic endophthalmitis, pyogenic granuloma, and limbal dermoid) and contributed 152 aliquots (including neoplastic tissue, iris tissue, muscle tissue, retinal tissue, aqueous humour, vitreous humour, subretinal fluid, and blood).

Conclusions: Understanding patient preferences and perspectives towards aspects of research may help us tailor communications and catalyze high‐impact research aligned with patient interests. Future steps include onboarding partner sites to increase enrollment, collection of bioimages, generation of additional resources such as tumour organoids, and promotion of the biobank to scientists to stimulate use of available resources.

PG‐07 Geospatial Biobank Mapping to Showcase the Specimen Story

W. Schleif

JHAC Pediatric Biorepository, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, United States

Statement of the Problem: Participant engagement often begins and ends with obtaining consent and the collection of biospecimens. For most, the biospecimen's journey through the interwoven layers of processing, storage, distribution, and analysis tells a story not often shared. Participants cannot be physically present at all of these steps; however, a virtual story map is an appealing and cost‐effective solution that opens up these steps and presents a visual audit trail for participants to follow.

Proposed Solution: We present our concept and process used to visually digitize the Johns Hopkins All Children's Pediatric Biorepository and research campus through the use of several software options commonly involved in architecture and real estate. The 3D mapping of the biorepository and geospatial‐linked specimen relationships present an opportunity to open up the research infrastructure at Johns Hopkins All Children's Hospital and provide a transparent window for our community to view and interact with the research process. We also share the challenges we encountered with many of the data‐sharing requirements associated with 3D mapping software‐as‐a‐service out‐of‐the‐box solutions.

Conclusions: We share our multi‐step digitization process that showcases the biospecimen journey as it travels through the common steps a typical biospecimen experiences (collection, processing, storage, distribution, and publication). This process is widely generalizable to all types of biobanks and provides a visual story for participants to connect with the complete research life cycle of their own biospecimens. This approach opens up biobanking in manner that both children and their families can appreciate.

PG‐08 Development of a Framework to Ethically Assess the Governance and Operations of a National, Multisite Biobanking Infrastructure

A. Costello¹, E. Vereker², NICB - REC¹

¹National Office for Research Ethics Committees in Ireland, Dublin 2, Ireland, ²National Office for Research Ethics Committees in Ireland, Dublin, Ireland

Background: In response to the COVID-19 pandemic, the Department of Health in Ireland invested funding to establish Ireland s first national, multi-site, multi-legal entity biobanking infrastructure: the National Irish COVID-19 Biobank (NICB). The NICB includes 13 clinical recruitment sites across the country as well as six academic sites, five of which are responsible for the storage of biosamples and associated data. It is crucial that the collection, storage, and use of bio-samples and associated data is underpinned by the highest standards in ethics, governance, and codes of practices. As such, the Minister for Health mandated the establishment of a dedicated research ethics committee (REC) to ethically assess all governance and operations of the NICB and to deliver a national ethical opinion.

Methods: The National Office for RECs in Ireland performed a scoping review of best practices in ethical biobanking and human rights to inform the development of the national ethical review process.

Results: The National Office:

Defined the terms of reference for the NICB-REC which were approved by the Department of Health.

Conclusion: The establishment of a REC which oversees the ethical robustness of a national, multisite biobanking infrastructure ensures the safety, autonomy and wellbeing of biobank participants in relation to the use, transfer, and interpretation of their biosamples and data for research. The Operational Framework produced by the National Office may serve as a reference for ethical assessments of biobanks in Ireland and beyond.

PH‐01 Pediatric Collections in Biobanks: Current Challenges to Bring Advances in Personalized Medicine into Pediatric Medical Care

T. D. Córdoba^1,2, C. Cañadas^1,2, A. Céspedes^1,2, I. Valiente^1,2, Á. Jiménez^1,2, A. Toledo^1,2, P. E. Ferro^1,2

¹Andalusian Public Health System Biobank, Instituto de Investigacion Biomedica de Malaga, Malaga, Andalucía, Spain, ²Instituto de Investigacion Biomedica de Malaga, Malaga, Andalucía, Spain

Pediatric sample collections are crucial in biomedical research as diseases occurring in this age group typically have a more diverse spectrum of abnormalities and greater rarity than diseases seen primarily in adults. Complexity and relatively small populations with specific diseases are factors that have hindered progress in the treatment of pediatric disorders. Personalized medical therapies designed specifically for people with unusual or unique problems, have great potential to help overcome these factors that have been a barrier to pediatric medical success.

There are currently several pediatric biobanks around the world, but it remains important to continue working to create strategic collections that can be made available to researchers to contribute to biomedical research in this area. One of the main problems that researchers encounter is the absence of control collections that are essential to validate the results obtained in pediatric biomedical research.

An analysis has been carried out of the coverage that the Malaga provincial node of the Biobank of the Andalusian Health System (BBSSPA) has had for the pediatric research community and the necessary strategies have been studied to increase the number of pediatric circuits and collections, as well as the actions carried out to create these collections of high research interest and determine the points of improvement to be able to create new collections of great interest and control collections that can be used to achieve excellent biomedical research.

The results of this study show that since 2019, nine pediatric circuits have been opened for the creation of new collections, covering 13 research projects (four of them in rare diseases) and three pediatric clinical trials.

In conclusion, it can be seen that the strategies adopted have allowed the creation of sample collection circuits where clinical collectors have been a key actor, although work must continue to have services and hospital units that can provide other collections of great interest, such as those intended for pediatric controls or rare diseases.

PH‐02 Enhancing Biosafety in SARS‐CoV‐2 Research: Immunoassay‐Compatible Inactivation of Plasma Samples for Safe and Reliable Protein Biomarker Measurement

O. Liew¹, J. Y. Ng¹, S. S. Ling¹, S. Lilyanna¹, J. P. Chong¹, S. Lim^2,3, A. Richards^1,4

¹Cardiovascular Research Institute, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore, ²Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore, ³Department of Cardiology, National University Heart Centre, Singapore, Singapore, Singapore, ⁴Christchurch Heart Institute, University of Otago, Dunedin, New Zealand

Background: Minimizing laboratory personnel exposure to SARS‐CoV‐2 requires effective virus inactivation of the test sample. This is typically achieved via thermal and chemical methods. Methods for successful SARS‐CoV‐2 inactivation in physiological buffers and cell culture media cannot be presumed to be effective in sera or plasma possibly due to a protein concentration‐dependent protective effect. Hence for protein biomarker measurements, it is crucial that the virus inactivation method used must be effective in blood‐derived matrices and compatible with downstream antibody‐based testing.

Methods: Plasma samples were subjected to heat (56°C; 30 minutes), Triton X‐100 (1‐3%) or solvent‐detergent (SD) (0.3‐1% tri‐n‐butyl phosphate [TNBP] and 1‐2% Triton X‐100) treatment and effects on analyte levels in 19 immunoassays across various assay platforms were assessed. Treatments were deemed immunoassay‐compatible when average and range of percentage recovery (analyte concentration of treated relative to untreated samples) lie between 90‐110 and 80‐120%, respectively. The effects of SD treatment (0.3%TNBP/1% Triton‐X100) on immunoassay results within 2 weeks and at 6 and 14 weeks post‐treatment were also evaluated. SARS‐CoV 2 inactivation in plasma samples post‐SD treatment were validated by plaque assays.

Results: Heat treatment had the most detrimental effect on immunoassays, drastically reducing or even completely abolishing assay signals. Although immunoassays were more tolerant of Triton X‐100 treatments compared with heat, recovery indicators fell outside of acceptable limits for some analytes at higher detergent concentrations. Immunoassay sensitivity to chemical‐based virus inactivation procedures was found to be dependent on both the analyte and assay platform in question. 0.3% TNBP/1% Triton X‐100 effectively inactivated SARS‐CoV‐2 and was compatible with 60% of the assays when tested within 2 weeks post‐treatment. The concentrations of some analytes were found to be stable at 6 weeks and 14 weeks post‐treatment. Viral plaques were absent in SD‐treated plasma across inoculum dilutions, confirming effective SARS‐CoV‐2 inactivation.

Conclusions: Triton X‐100 and SD treatments are superior to heat in terms of immunoassay compatibility. SD treatment with 0.3% TNBP/1% Triton X‐100 is a facile and immunoassay‐compatible SARS‐CoV2 inactivation method, preserving stable analyte levels for at least 2 weeks and up to 14 weeks post SD‐treatment.

PH‐04 Potential Value of Biobanking in Wastewater Epidemiology

K. Furuta¹, H. Abe², R. Honda³, M. Kitajima⁴, H. Kobayashi⁵, T. Kuroita⁶, A. Nemoto⁷, R. Shirakashi⁸

¹Chiba Medical Center, Chiba, Japan, ²Shimadzu Corporation, Kyoto, Japan, ³Kanazawa University, Kanazawa, Japan, ⁴Hokkaido University, Sapporo, Japan, ⁵Shionogi & Co., LTD., Osaka, Japan, ⁶AdvanSentinel Inc., Tokyo, Japan, ⁷Aquaxis Law Office, Tokyo, Japan, ⁸The University of Tokyo, Tokyo, Japan

Background: COVID‐19 put all of us in a very difficult situation in this past couple of years. At the same time, experiences in these difficulties provided opportunities for various innovations. Development of various online communication technologies is the one big example. Another intriguing example could be added to this list, such as pathogen detection by using wastewater samples.

During this pandemic, people realized, it is very difficult to detect the timing when pathogens were invaded into the community. Some of this author group proposed to utilize wastewater as a resource of pathogen detection. They were successfully confirmed that analyses of wastewater samples have indicated not only proof of the current infection but also an early sign of prevalence in the community.

Summary: In May 2020, a part of this author group started analyses of SARS‐CoV‐2 detection by using wastewater samples. The outcome was remarkable. One unique feature is using filters for analyzing wastewater. During these procedures, the group realized that these archived samples (filters) could be utilized for detection of diverse pathogens including variants in a longitudinal setting. This is the biobanking of wastewater samples. This biobanking made it possible for this group to find the following:

Evaluation of influences of COVID‐19 to those of influenza and/or RS virus infection.

Conclusions and Possibilities: Wastewater biobanking provides opportunities for analyses of samples retrospectively to obtain important public health insights at the population level; for example, when a pathogenic virus invades or emerges in a community, how effective public health interventions work for mitigating the prevalence of infectious disease, or whether the characteristics of infectious disease (e.g., epidemic level, genetic distribution, seasonality) change compared to the previous seasons.

The group confirmed the importance of WBE with filter‐biobanking, although “filter‐biobanking” in WBE needs further innovation.

“Filter‐biobanking” may have tremendous potential, if filters in general can be transported and/or stored in ambient temperature and/or a dry location. This may open the door for utilization of this technology into resourceless environments including low‐ and middle‐income countries.

PH‐05 Decarbonization in Biobanking

K. Furuta¹, H. Vu⁶, L. Organick², M. Scott³, R. Shirakashi⁴, Z. Kozlakidis⁵

¹Chiba Medical Center, Chiba, Japan, ²Cache DNA, Inc, San Carlos, California, United States, ³Trane Technologies, Davidson, North Carolina, United States, ⁴The University of Tokyo, Tokyo, Japan, ⁵International Agency for Research on Cancer, Lyon, France, ⁶Vinmec Healthcare System, Hanoi, Vietnam

Calls to reduce or entirely remove the carbon footprint of ongoing activities, collectively termed as decarbonization, have become increasingly more vocal in health care with a number of recent high‐profile consensus statements. These calls encourage the biobanking field, as one of the foundational health care research infrastructures, to consider decarbonization as a potential novel research area both in terms of the molecules and the equipment used in research.

This poster presentation is based on a summary of the roundtable discussions during the 2022 and 2023 ISBER Annual Meeting and Exhibits, highlighting the current knowledge gaps, challenges, and opportunities in this field.

In particular, technological innovation, a greater awareness of the current situation, and behavioral change are important pieces of the puzzle to improving the future of decarbonization in biobanking, even if the eventually implemented routes between resource‐abundant and resource‐restricted settings might be distinctly different.

This poster sets the foundation for raising awareness of the subject and of subsequent steps that need to be undertaken.

PH‐06 AI‐CBB: Exploring the Necessity and Feasibility of AI Coupled in Biobanking

W. C. Wang

Xinhua Hospital Affiliated to School of Medicine, Shanghai Jiao Tong University, Shanghai, China

Statement of the Problem: The emergence of ChatGPT at the end of 2022 has significantly propelled artificial intelligence (AI) into our daily lives and work spheres, challenging our perception of AI as a futuristic concept. Amid this shift, three essential questions arise: Is AI assistance necessary in the realm of biobanking? What are the primary application scenarios of AI in biobanking? And how can we structure biobanking operations in conjunction with AI to enhance decision‐making capabilities and predictive development?

Proposed Solution: In response to these inquiries, we have undertaken three major initiatives: 1) the establishment of the AI‐CBB forum (AI‐Coupled Biobanking Forum), focusing on discussions regarding the integration of artificial intelligence within the professional domain to construct robust biobanking systems; 2) the creation of a series of data metrics pertinent to biobanking, laying the groundwork for the digitalization of biobanking infrastructure; and 3) leveraging diverse real‐world business scenarios associated with different biobanks in China to craft varied application scenarios, along with devising universally applicable methodologies for digital transformation.

The crucial understanding is coupling AI enables interdependencies among multiple business scenarios, establishing continuity in business processes through AI‐driven decision‐making and forecasting. We need to recognize that developing specialized AI for biobanking remains an evolving field, with the algorithmic aspect—essentially, machine learning models—forming the crux of biobank AI. Adhering to the methodological principles we have set forth, leveraging the DIKW model's groundwork, which establishes the foundational attributes of constructing biobanks and their interrelationships. Implementing decision trees and random forest models as machine learning models for decision‐making and prediction. The decision trees model caters to accessibility for novices, being easier to interpret and understand, while the random forest model, through an amalgamation of multiple decision trees, provides heightened predictive accuracy.

Conclusions: The essence of applying AI in biobanking is to “blend” AI across diverse business elements, strategies, methods, or processes, integrating them to yield superior outcomes or effects according to decision‐making and prediction.

PH‐07 A Collaborative Virtual Biobank for Infectious Disease Research

P. Pillai², M. Turner³, J. Haurat³, W. Abdelaziz³, A. Bourne³, M. Z. Smith¹

¹Infectious Diseases, The University of Melbourne, Melbourne, Victoria, Australia, ²The University of Melbourne, Melbourne, Victoria, Australia, ³BioGrid Australia Ltd, Parkville, Victoria, Australia

Statement of the Problem: The response to the COVID‐19 pandemic has underpinned the value of rapid access to high‐quality biospecimens. Vaccine, diagnostic test, and antiviral development have all relied on swift access to biospecimens, as have the detailed investigations characterising the immune responses and consequences of infection. In infectious disease research, however, biospecimen collections are often limited in scope and number, with project‐specific governance and restricted sharing mechanisms for collaborative research. This leads to often underpowered or limited study findings and the under‐utilisation of precious resources held in distributed locations under separate and often non‐transparent access and governance arrangements.

Solution: Through the Australian Partnership for Preparedness Research on InfectiouS disease Emergencies (APPRISE), we have developed an ethically approved Virtual Biobank linking five existing biospecimen collections. The Virtual Biobank enables the discovery, integration, and interpretation of data relating to these diverse collections within their existing ethics and governance arrangements.

Building on international harmonisation efforts, we adapted the Minimum Information About Biobank Data Sharing standard to create a minimum information model (MIM) including essential information about the participating collections. Data from each collection are harmonised into a structured model database according to the MIM within the home institution infrastructure. A site application programming interface (API) transfers encrypted data to the Virtual Biobank API and returns aggregated data to the Virtual Biobank website when a query is made. No specimen‐specific data are stored in the Virtual Biobank, providing a model that enables real‐time visibility of multiple collections from a single site and protects the integrity of collection data and existing access processes.

Conclusions: The APPRISE Virtual Biobank demonstrates the feasibility of working with existing biospecimen collections to improve their accessibility and usage. The platform provides a single location from which to search multiple biospecimen collections, linking searchers with collection custodians. The first phase of the Virtual Biobank provides a valuable platform for expansion and further progress towards access and governance harmonisation. Ultimately, these efforts will improve access to infectious disease biospecimens in Australia.

PH‐08 Sampling for Body Clock Dysfunction in Mood Disorders

L. M. Wallace¹, A. Henders¹, J. Crouse², M. Shin², I. Hickie²

¹Institute for Molecular Bioscience, The University of Queensland, Saint Lucia, Queensland, Australia, ²Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia

Background: The circadian system is a regulator of health, and its dysfunction is a major cause of illness. It is very difficult to study the signature of circadian rhythms in humans in real time given the requirements of frequency and number of sample collections. The Human Studies Unit (HSU) together with a national team of multidisciplinary researchers is involved in a world‐first, highly granular investigation of body clock dysfunction in mood disorders. There are links between disturbed sleep patterns and mood disorders such as depression and bipolar disorder. The aim of the study is to develop precision “circadian therapies” to correct the body clock dysfunction for those with mood disorders. The project pilot has commenced whose objectives are to determine feasibility and establish the circadian signature based on healthy individuals.

Methods: The sleep study requires intensive sample collection and processing over a 24‐hour period. A participant will be canulated to provide blood samples at the frequency required for optimal biomarker analysis. A comprehensive collection protocol has been devised to allow for one staff member to administer including user‐friendly collection and processing kits, easy‐to‐read labels, and streamlined documentation. Samples will stored at various stages of the collection protocol for later aliquoting and on‐sharing for system genomics approaches by the HSU.

Results: Each participant will have a total of 280mL of blood and 42mL of saliva collected over 24 hours to measure 15 biomarkers involved in circadian rhythm and mood disorders, generating a total of 320 aliquots of serum, plasma, and saliva. The pilot will collect samples from 30 individuals amassing 9,240 serum, plasma, and saliva aliquots for distribution to four laboratories. To ensure data reliability the biomarkers will be analysed in duplicate, in batches at completion of collection, and will be reviewed for feasibility, data relevance, and significance.

Conclusions: Such studies are expensive and logistically complex to administer. HSU's quality control protocols developed for this protocol will offset potential collection deviations and across sampling variations by managing sample integrity and ensuring standardisation.

PH‐09 Biohoarding in Indian Biobanks –Navigating Challenges, Forging Solutions

J. Tayal¹, A. Mehta², B. Sharma¹, A. Sharma¹

¹Biorepository, Dept of Research, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Delhi, India, ²Laboratory Services and Molecular Diagnostics, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Delhi, India

Statement of the Problem: India is a developing nation where biobanking is dawning, and the challenge of biospecimen underutilization is a fast‐emerging concern. In India, the major biobank stakeholders are the researchers, biobank managers, and donors. Policymakers are the backseat drivers. The contributors to Indian biohoards are: defective internal governance, lack of marketing support, poor sample quality, and regulatory restrictions. However, an important factor that underpins the above issues is education and training regarding biobanks. “The eyes cannot see what the mind does not know”: the masses are unaware of the role of biobanks as pillars of research so lean frameworks based on limited knowledge are designed for governing biobanks in India. Eventually, biosample collections realistic or unrealistic are at the behest of the biobank manager. It is time to rise to the problem and assess it in a step‐wise manner because unrealistic collections with no set goals incur huge costs to the biobanks and also to the taxpayers in India.

Proposed Solutions: We designed a framework wherein we first identified the stakeholders who needed to be trained or made aware of biobanking aspects. So, for education and training purposes, we grouped them into two subsets: Internal and External. Internal training included training of technical staff and non‐technical staff, and External training included training the biobank fraternity. Methods of training included informal talks, round‐table meetings for OT staff and nurses, short videos of sample procurements and processing for biobank staff, representative sampling training for pathologists, and sharing webinar materials from ISBER archives with technical staff. A masterclass program was launched to educate researchers, biobank managers, scientists, pathologists, start‐ups, CROs, and clinical trial managers. External Group training also included an awareness program for the donors and their relatives on the biobanking aspects. Secondly, we assessed the biosample needs of researchers and became judicious in selecting biosamples for storage. A preanalytic check and a maintained BRISQ indicator sheet for every sample stored ensured clear‐cut segregation of samples as usable and non‐usable for various downstream applications. Thirdly, we worked towards our biobank visibility.

Conclusion: We demonstrate a framework that can prevent biohoarding. This framework can safeguard small‐sized biobanks from closure.

PH‐10 Establishing the United Kingdom Health Security Agency (UKHSA) COVID‐19 Biobank for Global Scientific Access

S. Cutler, S. Alexander

Culture Collections, UKHSA Biobank, UK Health Security Agency, London, United Kingdom

Statement of the Problem: Establishing a COVID‐19 biobank with residual diagnostic samples for the scientific community to access is a complex process. Considerations include ethics applications, governance arrangements, and implementing laboratory information management system (LIMS) and quality management systems. It is also necessary to determine which samples and metadata will be of most value. Samples, Consent, and Ethics: Samples within the biobank are residual diagnostic samples, collected by UKHSA during the COVID pandemic. An update to the existing Research Ethics application has been submitted so that these samples can be made available to approved scientific researchers. An opportunity to expand the biobank to include samples from well‐curated studies also exists. Therefore, developing a clear accessions and disposal strategy which clarifies the biobank remit, is a priority.

LIMS and Pseudonymisation: Many of the samples collected contain patient identifiable information (PII), so required relabelling and pseudonymising with a new LIMS number. The application of an inventory‐focused LIMS system which removes all PII is to be implemented, although a linkage will be maintained, as is good practice, and will enable metadata to be accessed.

Proposed Solutions: Applying for a second in‐depth research ethics application, alongside recruiting a resilient and quality‐focused biobank team, are priorities prior to the biobank becoming operational. Longer‐term goals include implementing the QMS ISO:20387 standard.

Developing a specimen and data strategy will ensure that the most scientifically useful specimens and metadata will be available to scientists which is likely to include: specimen type, gender, ethnicity, and COVID and vaccine status.

Once the above have been implemented, along with a non‐profit cost recovery solution to sustain the biobank and promotion of the collection, distribution of samples to approved projects can then be realised.

Conclusion: Establishing the UKHSA COVID‐19 biobank containing residual primary diagnostic samples and associated metadata is a complex process. Resources have been invested to ensure the biobank is both compliant with regulatory and ethical requirements and has the infrastructure in place to store and supply biological materials. It is anticipated that this resource, once operational, will be of great benefit to Biomedical community.

PH‐11 Everything Old Is New Again: Renewed Demand for Formalin‐Fixed, Paraffin‐Embedded Tissue

M. Griffin, E. Howington, K. Frankey, M. Datto, S. J. McCall

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

Background: The Cooperative Human Tissue Network (CHTN) was established in 1987 to ethically collect and distribute biospecimens for cancer research. Over the last decade, the network has distributed over 500,000 biospecimens to investigators in various tissue preparations including: snap frozen, OCT‐embedded frozen, fresh, formalin‐fixed paraffin‐embedded (FFPE) blocks/slides/scrolls prospectively collected according to the investigators' requests. During this same time period, there have been adaptations in biomedical research techniques leading to changes in the proportion of requested sample types. While a shift towards increasing requests and sample distributions for fresh tissue types has been observed by us and others over the last decade, the most recent data suggest a resurgence in FFPE requests and sample distributions.

Methods: The CHTN TissueQuest database was queried for tissue requests across the entire network from 2012 to 2022. Requests were categorized according to sample preparation type: formalin‐fixed paraffin embedded (FFPE), frozen, and fresh. Annual totals for each preparation type were calculated for both requests entered and shipped samples. These were then graphed and compared over the time period.

Results: From 2012‐2020, CHTN experienced a continual increase in the number of fresh tissue requests and fairly stable FFPE and frozen tissue requests. However, the number of fresh requests decreased in 2021 and again in 2022, while FFPE requests doubled during that same time period. The trend is also supported by shipment totals, with 2021 showing the highest fixed shipment total over the entire study period, and 2022 showing the lowest fresh shipment number since 2013.

Conclusion: Through CHTN's fundamental prospective procurement model, the network's sample distributions are a response to the expressed needs/requests of the scientific community. The observed re‐emergence of FFPE requests and distributions may represent a shift in research interests with a renewed focus on readily available pathology archival tissues helping to understand biology at specific disease timepoints or relevant to specific populations. Alternatively, advances in nucleic acid extraction methodology may have made FFPE a more reliable substrate. Additional study over time may be helpful to fully understand this trend.

PH‐12 Establishing a Fresh Surgical Surplus Diversion Workflow for Patient‐Derived Organoids in Primary and Metastatic Neuroendocrine Neoplasms

O. Bigun^1,2, A. Lin^1,4, K. Czibere^1,2, A. Misura^1,2, D. Gowlett‐Park^3,5, R. Sasso^3,6, T. Khazaee^1,2, S. Chow^1,3, Z. Wang^2,7, N. Kulathunga², B. Li², D. Andrews^2,7, I. Michael^2,7, H. Tsui^8,9

¹Sunnybrook Biobank, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, ²Biological Sciences Platform, Sunnybrook Research Institute, Toronto, Ontario, Canada, ³Division of Medical Oncology and Hematology, Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre Odette Cancer Program, Toronto, Ontario, Canada, ⁴Department of Pathology and Laboratory Medicine, Western University, London, Ontario, Canada, ⁵Sunnybrook Research Institute Evaluative Clinical Sciences Platform, Toronto, Ontario, Canada, ⁶Arts and Sciences Cooperative Program, University of Toronto Scarborough, Toronto, Ontario, Canada, ⁷Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada, ⁸Division of Hematological Pathology, Department of Laboratory Medicine and Molecular Diagnostics, Precision Diagnostics and Therapeutics Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, ⁹Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

Problem: Personalized cancer therapy depends on the study of fresh primary human tumors. For many scientists, clinical barriers to access can be challenging to overcome. To align the high volume of new cancer patients seen at the Sunnybrook Odette Cancer Centre with the scientific expertise of the Sunnybrook Research Institute, the Department of Laboratory Medicine and Molecular Diagnostics, Precision Diagnostics, and Therapeutics Program launched a biobanking initiative to divert fresh surgical surplus for research use. This pilot targeting neuroendocrine neoplasm (NEN) surgical candidates harvested primary and metastatic NEN tissue for generating patient‐derived organoid (PDO) models. Adjacent snap‐frozen tissue was also biobanked from clinically sampled regions. We here describe an approach to fresh tissue diversion demonstrating its feasibility and rapid contribution to research productivity.

Proposed Solution: Biobank staff outreach with NEN surgical oncologists, clinic administrators, and clinical trial coordinators was undertaken to understand patient workflows and map the patient journey through the intake process, regular clinic visits, routine phlebotomy, and operating room scheduling. Advance planning with operating room staff and anatomic pathology personnel was further evaluated to chart the transit of specimens through the clinical pipeline and develop an optimal decision tree/protocol for fresh tissue division and biobanking. In brief, the viable primary tumour site and up to four metastatic deposits (> 0.5 cm³) were targeted for biobanking. Plasma samples were collected during pre‐anesthesia assessments and timed to coincide with routine bloodwork. De‐identified pathology reports provided annotation to researchers. Coordinated delivery of fresh tissue in culture media supplemented with antibiotics provided primary biospecimens for PDO generation. NEN tissue from 10 patients (n = 27 tissues) yielded 100% successful organoid lines sourced from primary intestinal tumours and liver, lymph node, and mesenteric metastases. PDOs were then characterized for response to therapeutic drugs using high‐content cellular analysis.

Conclusions: Pre‐planned, coordinated access to fresh viable human cancer cells is a significant logistical barrier. Herein, a clinical laboratory directed biobanking initiative has demonstrated the feasibility of diverting fresh surplus surgical tissue yielding highly efficient generation of NEN‐PDO models.

PH‐13 Decarbonization, Sustainability, and Efficiency: Is a Green and Cost‐Effective Biorepository Possible?

S. Jeffrey

BioSolutions, StageBio, Mt. Jackson, Virginia, United States

Problem Statement: Is a green and cost‐effective biorepository possible while pursuing decarbonization?

Proposed Solution: In this presentation we will explore how the convergence of infrastructure, technology, equipment, and operations interact to address green and decarbonization goals in an attainable timeframe and budget within the biorepository space.

Infrastructure: Costs and carbon emissions related to infrastructure and build‐out can be substantial. By understanding new technology and sample management methodologies, enormous strides can be made in electrical, HVAC, back‐up power, and maintenance decarbonization efforts.

Technology: By introducing phase change material to the ultra‐low environment and increasing thermal mass sample stability can be increased and recovery times can be decreased with the potential of 3 × improved temperature hold times and greater operating efficiency, all lowering the carbon footprint. Compressor technology will also play a role major role in this area with savings of 30%+ possible. Understanding the cost vs. benefit analysis will be essential as this technology is adopted and integrated into biobank environments.

Equipment: As ultra‐low temperature (ULT) equipment continues to advance significant energy performance gains can be realized. By leveraging larger, more accurate ULT cabinets the per‐sample energy rate will decrease. These larger cabinet sizes in conjunction with the more sophisticated compressor technology available, along with new equipment programing strategies, will substantially decrease the carbon footprint.

Operations: Multiple adjustments to operational practices can be made to decrease the carbon footprint and decrease energy consumption. One popular and simple adjustment is to lower the cabinet temperature of the ULT which can result in savings of up to 20+%, assuming project‐specific protocols allow for this adjustment. Best practices can also be adopted for ULT management to minimize the energy required in long‐term and short‐term applications.

Conclusion: The convergence of infrastructure, technology, equipment, and operations can be leveraged to address green, cost‐effective, and decarbonization goals in an attainable timeline and budget for the biorepository industry.

PH‐14 Using Big Data from Biobanks to Bring Precision Medicine

D. Kelly^1,2

¹Department of Laboratory Research, United Bio‐Research, Taylorsville, Utah, United States, ²ARK Repository, Murray, Utah, United States

Background: In today's world there is an increasing demand for large amounts of patient data to be used to scale up research that would lead to new discoveries and new cures for many diseases. Like many industries that are striving to fulfill the needs of their consumers by providing custom products and services, the medical world is seeking to implement personalized medicine. Currently only the elites & celebrities have access to precision medicine. Research using big medical data is the key to unlocking the discoveries necessary to bring precision medicine into the modern world. Getting access to this data is very challenging for researchers, due to privacy and ethics laws that are necessary to protect patient data.

Methods: With the help of my colleagues, I have been able to work with large biobank data, including how to interpret and parse medical outcome data from self‐reported assessments, hospital in‐patient records, and other sources. We used an example disease to compare different data sources and assessed how they might affect genetic analyses. We found a viable method for how to work with omics data at this scale. We used the recently released nuclear magnetic resonance metabolomic biomarker dataset to show how additional data types can supplement genotype‐phenotype studies. We looked at what kind of effects are important to consider in data from hundreds of thousands of samples that may not matter as much in smaller studies, and how to use quality control procedures to mitigate them. Our results were successful in analyzing the data and found many correlations between different diseases.

Conclusion: This is a more effective and efficient way of managing research, as it eliminates all the costly logistics involved with moving the specimens from the biobank to wherever in the world that the research is being conducted. This is much more practical in the digital world we live in; where everyone wants everything higher quality, faster, and cheaper.

PH‐15 The CU Regenerative Medicine Biobank (CURE Bank): A Novel Concept to Address Challenges to Offsite Collection of Surgical Tissues

R. McCarrick‐Walmsley, K. Whitney, Q. He, V. Butler, J. L. Dragoo

Orthopedics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Statement of the Problem: 1. There is an unmet need in orthopedic translational research for access to normal and abnormal musculoskeletal tissue paired with genomic and clinical data. 2. Academic and industry researchers require rapid production of pilot data in order to secure funding. 3. Demographically diverse patient samples and data are required for the generation of significant findings. 4. Samples collected are typically biased toward a specific use, such as flash frozen for RNA or paraffin embedded for histology, which limits their usefulness.

Proposed Solutions: The CURE Bank has been designed to collect surgically discarded tissue from patients undergoing orthopedic procedures in order to provide an individualized atlas of involved tissues along with demographic, clinical, and genomic data, creating an invaluable resource for researchers. Our novel method of collection involves identically cryopreserving tissue aliquots such that each can be used for any downstream purposes. Tissues, such as adipose, bone, cartilage, ligament, tendon, and meniscus, are collected in the operating room, placed into cold buffer, dissected into 100‐200‐mg pieces, submerged in Bambanker Standard cryopreservative in color‐ and bar‐coded cryovials, then moved immediately onto dry ice. Within 5 minutes of removal from the patient, 4‐10 aliquots of each tissue discarded in the course of surgery are stably frozen to preserve viable cells, structurally intact tissue, and fully stable RNA and protein. This process can be performed in a large hospital setting or a small clinic with no access to specialized equipment. We have identified the laboratory information management systems database that can link the detailed sample and clinical data, create a collection kit composed of wet ice and dry ice sections, and prefill cryovials that can be overnight shipped. In addition, we have developed QA/QC processes to demonstrate the suitability of samples for downstream uses such as cell culture and scRNAseq, bulk RNA and protein isolation, and histological assays.

Conclusion: We have developed the novel collection concept, quality assessment tools, and database design to create a fully outsourceable, easily expandable, regenerative medicine biobank that will be available to academic and industry researchers interested in obtaining high‐quality, unbiased biospecimens and associated clinical and demographic data. While developed for orthopedic research questions, these concepts translate to any tissue biobank.

PI‐01 The SKMCH&RC Biobank: A Clinico‐Biological Database of Cancer Patients from Pakistan

K. Asghar¹, A. Farooq¹, M. Hassan¹, A. Loya²

¹Basic Science Research, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, ²Pathology, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Punjab, Pakistan

Background: With a population of approximately 241.49 million, Pakistan represents 2.99% of the world's population. Yet, research infrastructure in the country grapples with limited funding and a significant disease burden, including the diagnosis of 178,388 new cancer cases in 2020. In this context, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), a JCI‐accredited, charitable, not‐for‐profit cancer hospital, emerged as a beacon of hope. In 2022 alone, SKMCH&RC registered 7,285 new cancer patients, amassing a substantial database of cancer cases. In February 2019, we established a unique biobanking facility tailored to cancer patients based on the standard operating procedures developed by the Canadian Tissue Repository Network (CTRNet), leveraging our institutional resources. The primary goal of this facility is to comprehensively characterize clinico‐biological and cancer‐related factors crucial for the effective treatment of cancer patients.

Methods: Our approach involves enrolling treatment‐naïve cancer patients who provide informed consent for biobanking. Each sample is assigned a unique code to ensure patient data confidentiality. We meticulously record clinical, pathological, radiological, demographical, and treatment‐related information for every stored sample.

Results: The SKMCH&RC biobank currently houses approximately 1,217 frozen samples representing a diverse range of malignancies, including breast, brain, cervical, colorectal, endometrial, gastrointestinal, head and neck, liver, lung, ovarian, pancreatic, renal, sarcoma, thyroid, testicular cancers, and lymphomas. Patient records integrated into the biobank include gender, age, comorbidities, cancer history (type and stage), pathology lab tests (LFTs, RFTs, CBC, histopathology), and radiology tests (X‐ray, CT scan, MRI, PET scan). Comprehensive treatment data, covering surgery, chemotherapy, radiation, and palliative care, is also available.

Conclusion: The SKMCH&RC biobank is a member of the Biobank and Cohort Building Network (BCNet) and has actively shared its biobanking experiences across various platforms. Recently, we have initiated a biobank clinic to increase public awareness of biobanking, addressing the relative underdevelopment of biobanking in our region. This resource positions us to foster international research collaborations with academia and research institutions, potentially playing a pivotal role in advancing cancer management and research on a global scale.

PI‐02 GenV: A Population‐Representative Birth Mega Cohort with Matched Breastmilk and Infant Stool Samples

Y. T. Mangwiro‐Budahazy¹, A. Fedyukova¹, K. Powell¹, M. Williams¹, T. Frugier¹, W. Siero¹, J. Mohal¹, C. Lai², M. Wlodek^1,4, M. Wake¹, D. Geddes^1,4, R. Saffery^1,3

¹Murdoch Children's Research Institute, Parkville, Victoria, Australia, ²The University of Western Australia School of Molecular Sciences, Perth, Western Australia, Australia, ³The University of Melbourne Department of Paediatrics, Parkville, Victoria, Australia, ⁴The University of Melbourne Department of Obstetrics and Gynaecology, Parkville, Victoria, Australia

Introduction: Exclusive breastfeeding rates amongst Australian mothers drop from 96% to 15% by 6 months. This affects maternal and infant health, and potentially compromises the infant gut microbiome. The first longitudinal study of its kind, GenV aims to establish the largest inclusive and diverse biobank spanning early pregnancy and infancy, allowing research into the detection of early milk biomarker signatures predictive of low breastmilk supply, early breastfeeding cessation, and impacts on the infant gut microbiome.

Methods: Parents of every child born in Victoria over a 2‐year period (commenced 4th October 2021) were offered the opportunity to participate in GenV and provide a range of data and biosamples. In the 2nd year of recruitment ∼16,000 home collection kits were distributed to GenV participants. These included 7‐day+ post birth infant stool and breastmilk collection kits containing a unique breastmilk preservative that allows stable large‐scale home collection and transport at room temperature.

Results: There was a very high return rate of the biosamples (49% [5,591 breastmilk and 6,037 stool]) which have been processed and stored in our purpose‐built, fully automated ‐80°C biobanking facility. Participants providing samples closely represent the Victorian population sociodemographic profile in areas such as maternal age and Socio‐Economic Indexes for Areas (SEIFA). GenV breastmilk samples stored using the preservative are fit‐for‐purpose. The samples (n = 96) demonstrate comparable breastmilk component levels to fresh samples, aligning with pilot feasibility test results for the preservative conducted before recruitment.

Conclusion: At this large scale, the breastmilk and stool samples collected present unique opportunities for research investigation and collaboration both within Australia and internationally to explore at a population level the relationship among breastmilk components, cessation, and the infant gut microbiome. Importantly, it will facilitate research to support mothers in breastfeeding their infants, improve infant outcomes, and reduce the incidence of preventable health consequences for mothers and their infants.

PI‐03 Creation of a Pediatric Brain Tumor Biobank: Utilization and Modernization of Data Collection

K. Leonard¹, K. McCortney^2,3, J. Walshon^2,3, M. Flowers^2,3, C. Horbinski^2,4, M. DeCuypere^1,2

¹Department of Neurosurgery, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, ²Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, ³Malnati Brain Tumor Institute of the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, ⁴Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Statement of the Problem: Biospecimens annotated with relevant clinical data are an incredibly valuable research tool. However, determining clinical variables of the greatest value can be difficult to determine. At Lurie Children's Hospital of Chicago, the Neurosurgery department is working to establish the Pediatric Nervous System Tumor Bank (PNSTB). This biobank focuses on the collection of tumor samples, control tissue, and associated blood components from patients who consent to participate in research approved by the Lurie Children's Hospital Institutional Review Board (IRB 2021‐4677).

Proposed Solution: To allow for a diverse pool of users, the PNSTB utilizes an online, cloud database (REDCap) to house the associated clinical data for our biospecimens. The PNSTB REDCap project comprises distinct sections that create subsets of data types pertinent to researchers. For example, the “Patient Demographics” section includes age, gender, race, and ethnicity while a separate section contains protected health information (PHI). The “Sample Demographics” and “Biobanking Information” sections contain information specific to tumor diagnosis (i.e., molecular markers, overall survival) and sample aliquots collected, respectively. These distinct data sections allow for more control and improve data security (i.e., PHI vs non‐PHI). To further refine the database, prominent local experts in the pathology department developed a list of important molecular characteristics across all pediatric central nervous system tumors. Molecular diagnostics have increasing become the gold standard for tumor diagnoses and through this collaboration, we were able to develop a targeted list of molecular characteristics that researchers will find beneficial when accessing the database.

Conclusions: The PNSTB at Lurie Children's Hospital of Chicago is poised to become a highly valuable resource in the pediatric brain tumor research domain. In modernizing the methods of sample and data collection, we allow for the unique opportunity of customization and ease of use. In doing so, this ensures that any additional information requests will require minimal additional attention and will ultimately expedite research results.

PI‐04 Next Gen Biobanking ‐ An Indian Model Integrating Human Biological Samples with Digital Pathology, R&D, and Computational Biology

S. Ayillath Keezhadath¹, N. Aswini¹, C. Baibatha¹, A. Balakrishnan¹, K. Joy¹, J. Subramanian¹, N. Nambiar¹, D. Prasan¹

Biobank, 64 Codon, Cochin., Kerala, India

Statement of the Problem:

India accommodates 1/5th of the world population. In over 10,000 hospitals doing cancer surgeries in India, after the surgery, most of the remnant tumor tissues and HBS are discarded as biomedical waste. These HBS are precious materials and are inevitable for cutting‐edge pre‐clinical medical research. High‐quality ethically collected, well‐curated, value‐added multi‐ethnic Asian Indian population HBS have a good demand among new drug and diagnostics researchers globally. Most of the biobanks in India are single institution/hospital based.

Proposed Solution:

Our unique platform model open‐network biobank connects hospitals and labs across India. We collect HBS with clinical and molecular data, after removing Personal Identifiable Information at its source. We strictly adhere to the 2017 ICMR Biobank guidelines and ISBER Best Practices and standard operating procedures. In‐house IEC registered with CDSCO & DHR ensures ethically collected HBS. Built in‐house, custom‐made software ensures the efficient archival and retrieval of HBS. We are creating an Indian tumor genomic atlas and image repository.

PI‐06 Human Studies Unit – A Collaborative‐Services Approach for Human Research

L. M. Wallace, A. Henders

Institute for Molecular Bioscience, The University of Queensland, Saint Lucia, Queensland, Australia

Background: The Human Studies Unit (HSU) attached to the Centre for Population and Disease Genomics at the Institute for Molecular Bioscience, The University of Queensland provides collaborative research services in the area of human research and specifically in the high‐risk area of genetic and genomic research. The HSU provides dedicated project management, recruitment, and laboratory services and infrastructure and data analytics to collaborators both in Australia and internationally. The HSU is internationally certified through the Canadian Tissue Repository Network.

Methods: The HSU supports several biological sample collections, each with their own research governance, and is managed under a governance framework that is distinct from conventional biobanks and biological registries. The HSU infrastructure and research governance enables multiple human research projects to be supported simultaneously in the areas of participant recruitment and consenting, real‐time capture of clinical and self‐reported data; receipt, handling, and storage of biological samples; and data analytics. It runs a collaborative research services model as well as engages with sponsored clinical trials and commercial companies. Management of each human research project ensures ownership of samples and data is retained by the Principal Investigator and aspects of the Human Ethics approvals that involve the HSU are upheld.

Results: The HSU offers the research community centralised expertise and research infrastructure across six domains to support human research projects with specific expertise being in the genomics space:

Establish projects (build and implement study protocols).

Conclusion: The HSU is a dedicated facility supporting human research projects that include genetics and genomics as part of their research aims.

PI‐07 Quality Assessment of Fresh Frozen Cancer Tissues Stored at Shaukat Khanum Memorial Cancer Hospital and Research Centre Biobank

A. Farooq¹, M. Hassan¹, A. Loya², K. Asghar¹

¹Basic Science Research, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, ²Pathology, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Punjab, Pakistan

Background: Pakistan grapples with a substantial cancer burden, with 178,388 new cases in 2020, underscoring the urgent need for research. In 2019, we established a biobanking facility at the Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), preserving fresh frozen tissues from treatment‐naïve cancer patients with their informed consent. Our mission is to amass cancer specimens for translational research, meticulously upholding specimen integrity through rigorous quality assessments.

Methods: We assessed the quality of 46 frozen tumor tissues over various time points by extracting nucleic acids (DNA & RNA). DNA was extracted from 25 tissues using the QIAamp DNA Mini Kit (Qiagen, USA, cat no. 51304), and RNA was extracted from 21 tissues using the RNeasy Mini Kit (Qiagen, USA, cat no. 74104). Both DNA and RNA yields and purity were quantified using the NanoDrop 2000 (Thermofisher Scientific, USA) for precise measurements.

Results: SKMCH&RC's biobank holds 1,255 diverse cancer samples snap‐frozen in liquid nitrogen and stored at ‐80°C. The quality was confirmed through analysis of 46 randomly selected specimens. The outcome of this assessment underscores the biobank's excellence, with an average DNA yield of 383.9 ng/μl (ranging from 122.1 ng/μl to 684.3 ng/μl) and an average RNA yield of 555.7 ng/μl (spanning from 200 ng/μl to 2533.5 ng/μl). Furthermore, the 260/280 ratio for DNA exhibited an average of 1.89 (within the range of 1.80‐2.04), while the 260/280 ratio for RNA averaged 2.02 (within the range of 1.92‐2.15).

Conclusion: These findings serve as compelling evidence affirming the purity and integrity of DNA and RNA extractions from our tissue samples, reinforcing the credibility of our biobank for translational research. To further elevate the accuracy of our sample quality assessment, we are adopting cutting‐edge tools like the bio‐analyzer in our future endeavors.

PI‐08 kConFab – 26 Years of Biobanking and Participant Notification of Clinically Significant Mutations

H. Thorne

Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

kConFab, the Australian/New Zealand consortium for research into families at high risk of breast and ovarian cancer, has completed collection and recruitment of 2,132 families during the past 26 years to facilitate a range of research in multi‐case breast, ovarian, and prostate cancer families. Biological, genetic, epidemiological, and psychosocial data are collected from affected and unaffected, female and male participants over the age of 18. This material is available to peer‐reviewed, ethically approved research projects. In total, kConFab has supplied biospecimens and/or data to 207 research projects worldwide.

The kConFab biological repository contains blood specimens from a total of 14,845 participants. The standardized blood processing protocol produces plasma, non‐lymphocytes, blood pellets, and viable white blood cell fractions that are used to produce EBV‐transformed cell lines.

97% of kConFab families have undergone genetic testing identifying 48% of families with a pathogenic, large genomic rearrangement or splice site mutation in either BRCA1 or BRCA2 with a further 1% with mutations in the ATM, CHEK2, PALB2, BRIP1, RAD51C/D, PTEN, or TP53 genes. Of the 2,562 female participants who harbour a pathogenic germline mutation, 68% are affected with breast or ovarian cancer. We routinely action mutation notification to families that carry a C4‐5 variant.

kConFab has collected a total of 1,550 fresh tissue collections, including prophylactic mastectomy and oophorectomy specimens, and has a large collection of archival specimens, many of which are on tissue microarrays. The tissue bank consists primarily of breast, ovarian, and prostate tissue (tumour and normal). For the past 10 years we have run a rapid autopsy program to facilitate research into the mechanisms of resistance, metastasis, and cancer evolution using genomic and biological tools. Thirty‐five rapid autopsies from breast, ovarian, and prostate cancer patients have been performed.

Over the past year kConFab has been collecting a new annual ctDNA blood sample from unaffected BRCA1 and BRCA2 mutation carriers and BRACX participants which will be linked to their annual mammogram‐imaging report for use in an early breast cancer detection assay to progress research in personalized cancer prevention and screening strategies (http://www.kconfab.org).

PI‐09 Rapid Autopsy Programs Driving Research toward Better Therapy

L. Devereux, H. Thorne

Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

The Problem: Cancer tissue bio‐banked for research is commonly obtained from resected primary tumours. At tumour progression, patients commonly have less surgical intervention resulting in significantly less metastatic samples bio‐banked. It is established that multiple cancer genomes can exist within individual patients and even within a single tumour. Expanded knowledge of the relationships between inter‐ and intra‐tumoural genetic heterogeneity and cancer evolution will profoundly influence patient outcomes. Stable models of tumour metastases are valuable tools in development of therapeutic approaches to suppress metastatic disease.

Our Solution: Autopsies provide an opportunity to obtain a comprehensive survey of tumour deposits and relatively large amounts of material. For the past 10 years a rapid autopsy program in cancer patients called CASCADE has been operating at our institute with a focus on breast, ovarian, prostate, melanoma, lung, and head and neck cancers and rare tumours. In addition, a breast cancer‐focussed program called BROCADE has been established nationally with a focus on creation of Patient‐Derived Xenografts (PDXs) from surgically removed primary tumours and metastases collected at autopsy. Through CASCADE we have created a bio‐bank of metastatic tumour tissue matched with primary tissue and clinical data from 136 cancer patients to investigate mechanisms of resistance, discordant treatment response, metastasis, and cancer evolution using genomic and biological tools to facilitate precision medicine. In addition, the BROCADE resource has comprehensively sampled tissue from 23 rapid autopsy donors with metastatic breast cancer. A total of 63 PDX models have been created and expanded to enable access by multiple research groups. These represent both primary and metastatic disease with multiple models for some individuals. Normal tissue is also collected for approved, cancer‐associated studies.

Conclusions: These rapid autopsy programs have established a recruitment process that is well accepted by patients and clinicians. Material collected is of high quality and utilised by a large number of individual research projects. We have developed a rich resource of formalin‐fixed paraffin‐embedded, snap frozen, viably frozen, and PDX models for research. Our resource supports translational research of vital importance to managing metastatic cancer in the precision medicine setting.

PJ‐01 Exploring Perspectives to Facilitate Communication between Donors and Biomedical Research Biobanks: A Qualitative Study

P. E. Ferro^1,2, T. D. Córdoba^1,2, M. Hortas^1,3

¹Andalusian Public Health System Biobank, Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain, ²Instituto de Investigacion Biomedica de Malaga, Malaga, Andalucía, Spain, ³Hospital Costa del Sol, Marbella, Andalucía, Spain

Biobanks are non‐profit platforms at the research service which host collections of biological samples. These structures must guarantee the storage of human biological samples based on optimum quality, harmonization, and safety criteria, respecting at all times the ethical and legal requirements that guarantee the rights of donors. Currently, the development of multiplatform web applications is essential to allow donors and researchers to access information related to the management, location, and use of the donated sample. In addition, it would make possible to have the informed consents related to the process and its follow‐up by the patient in the research projects and clinical trials in which they are involved. The objective of this qualitative study is to know the opinions and experiences of different social groups involved in the subject of the study, related to the characteristics and dimensions that this application should contain and if it is of interest to all groups: donors, clinicians, and researchers. Results obtained show that there is great ignorance on the part of donors and patients about what biobanks are, their involvement in biomedical research, and their usefulness in the management of biological samples. Furthermore, there is a lack of general information about the Andalusian Registry Donors, both by patients, citizens, and associations representatives and by the different clinical professionals and researchers who attended the expert groups. For this reason, a multiplatform web applications would be more useful for donors, clinicians, and researchers, since it would help them to become aware of the importance of using samples for research, the relevance of biobanks and their usefulness, as well as improve communication between researchers and patients. Even so, it is necessary for biobanks to implement strategies and plans that make these structures known to patients and donors, as well as the crucial role they play in biomedical research.

PJ‐02 Real‐Time Informatics Approaches to Enhance Utilization and Effectiveness of Institutional Biorepositories

W. L. Schulz, D. Ferguson, P. Young, S. Pandya, T. Durant

Laboratory Medicine, Yale School of Medicine, New Haven, Connecticut, United States

Background: The Yale School of Medicine (YSM) Biorepository was established in 2020, initially to support the collection of COVID‐19‐related biospecimens, but has since expanded to support over a dozen funded research projects in addition to clinical laboratory test validation. Since its inception, over 300,000 aliquots have been processed, including blood, sera, plasma, and peripheral blood mononuclear cells. Supporting real‐time specimen acquisition required the implementation of an informatics pipeline to identify relevant specimens and manage associated operational and clinical data.

Methods: The YSM Biorepository has deployed an informatics framework that is integrated with the Yale‐New Haven Health clinical information systems. This allows for the real‐time screening of specimens using open‐source tools and internally developed software leveraging the Observational Medical Outcomes Partnership data model. These tools have been integrated with the Freezerworks biospecimen management (BSM) software for overall biospecimen management.

Results: The infrastructure developed routinely processes over 2,000 real‐time results per second. The integration of this software with our specimen handling robotics and the validated Freezerworks BSM software allows us to accurately manage aliquot location, remaining volume, and other required regulatory information with minimal manual intervention and without the loss of any aliquots to‐date. Of the approximately 300,000 aliquots processed by the YSM Biorepository, over 100,000 aliquots have been banked with a utilization rate of over 30% of collected specimens.

Conclusions: The integration of real‐time informatics in the YSM Biorepository significantly enhances biospecimen identification and utilization, offering a more efficient, cost‐effective approach to biobanking. This method not only streamlines the specimen collection process but also facilitates precise specimen identification, thereby increasing the value and usability of biorepository resources. Furthermore, the development of a new large language model‐based application is underway to enhance information extraction for select specimens. This infrastructure represents a significant advancement in biobanking informatics and is poised to make substantial contributions to accelerate biomedical research across the T0‐T4 spectrum.

PK‐01 Novel Dry Technology for Stabilization and Room Temperature Storage of Whole PB Samples.

M. Martín Ayuso¹, P. Penalosa¹, M. G. Alvarez¹, A. Henández¹, S. Barrena², M. Morgado¹

¹R&D, 300K solutions, Salamanca, Spain, ²Servicio de Citometría Universidad de Salamanca, Salamanca, Spain

Peripheral Blood (PB) is a widely used biospecimen in the field of biobanking since it plays a key role in clinical research. Its various components provide a multitude of possible applications such as immune profiling, proteomics, and genomic studies, among others. With such versatility in its uses, it is desirable that blood be optimally collected and stored.

Although there are several commercially available solutions to preserve cells fixed for some days the most common choice is the cryopreservation of peripheral blood mononuclear cells (PBMCs), where samples can be collected during the recruitment and be further analyzed. This requires specialized ultra‐low freezer facilities, complex shipment procedures, and no exemption from the possibility of losing the samples. Moreover, there are studies describing the selective cell loss during PBMCs in the recovery after thawing the samples that may induce a bias in subpopulation distribution.

These limitations can be addressed with optimal storage conditions of whole PB in a standard process that minimizes the pre‐analytical variation. The technique here proposed includes an innovative approach consisting of stabilizing the sample with a precision drying technique.

We evaluated the suitability and applicability of this stabilization system where six PB samples were processed in fresh, part was stored at ‐80°C, and part of the sample was dried and stored at room temperature. The overall recovery was 44.56% of cellularity in frozen and thawed samples, and 62.53% in freeze‐dried and rehydrated cells. When compared in the same samples, the frequency of the different subsets by flow cytometry (B cells, T cells, NK cells, monocytes, and neutrophils), we found a frequencies correlation of 0.99% in fresh vs freeze‐dried samples, while when comparing frozen and fresh values the frequency correlation was 0.56%, mainly due to the loss of myeloid cells in frozen samples.

In terms of nucleic acids, DNA extraction was performed in fresh, frozen, and dried aliquots, showing a similar quality and functional profile following the ISBER standards for quality control assurance.

The alternative here evaluated offers the possibility of stabilizing and storing whole PB at room temperature to be used for a wide range of downstream applications, including flow cytometry, protein analysis, or genomic techniques such as NGS. This implies that precision drying is an innovative, sustainable, and accurate choice for the room temperature PB storage in biobanks.

PK‐03 Using the ACT Label to Make Sustainable Laboratory Equipment Purchases

K. R. Bell¹, A. Armstrong¹, C. Greever‐Wilson², W. Marin¹

¹Thermo Fisher Scientific Inc, Waltham, Massachusetts, United States, ²My Green Lab, Salt Lake City, Utah, United States

Problem: Purchasing laboratory products is essential for research institutions and biobanks, but poor procurement choices can lead to future excessive energy consumption and overuse of other resources. Inefficient cold storage workflow practices like excessive maintenance and non‐optimized sample storage can come from a lack of product detail transparency and poor awareness of product impacts. The non‐profit organization My Green Lab has introduced the ACT Label, which aims to provide users with a clear understanding of the environmental footprint of laboratory goods and equipment based on independent third‐party audits of products and manufacturing facilities. Partnering with manufacturers such as Thermo Fisher Scientific can help assess the utility of the ACT Label for biobanks globally.

Proposed Solution: This abstract explores the problem of unsustainable laboratory equipment procurement and proposes early adoption of the ACT Label from My Green Lab as a solution to better understand and promote best practices for biobanks. The ACT (Accountability, Consistency, and Transparency) Label offers a standardized framework for evaluating and comparing the environmental impact of lab products. It includes cradle‐to‐grave metrics, such as energy consumption, product material content, and shipping impact, verified through an independent third‐party audit. By leveraging the ACT Label, cold storage users can make informed decisions when purchasing Thermo Fisher Scientific lab equipment to improve operations via waste reduction and energy cost savings.

Conclusions: Biobank industry partners have both an opportunity and social responsibility to work with organizations like My Green Lab. It offers several impactful programs, including the ACT Label, Freezer Challenge, and Accredited Professional Program, that industry partners can utilize to establish their commitment to sustainable science and support researchers to make enduring change. With the largest catalogue of ACT‐labeled lab product offerings, Thermo Fisher Scientific keeps innovating to serve biobank customers while actively minimizing the global footprint of science. By promoting awareness, highlighting long‐term cost benefits, fostering collaboration, and implementing tracking and reporting mechanisms, research institutions and biobanks can play a pivotal role in mitigating the environmental impact of laboratory equipment while advancing scientific discovery and enhancing efficient workflows.

PK‐04 Data Standards and Harmonization to Facilitate Data Sharing from Cancer Moonshot Biobank

P. Guan¹, A. Mohandas², V. Gopalakrishnan¹, J. McLean², M. A. Jensen², A. Rao¹, H. J. Ellis³, J. W. Wanyiri², L. Agrawal¹, S. McDermott², P. M. Williams², H. M. Moore¹

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

Statement of Problem: Biobanking has become one of the fastest‐growing fields in biomedical research with a global market value estimated at $59 billion for 2023. Effective sharing of banked specimens and associated data is critical to achieving and extending the value of biobanking. However, failure to adapt to established data standards can result in incompatible data, and lack of harmonization among various data sets can lead to disconnection among different cohorts or repositories. NCI's Cancer Moonshot Biobank has addressed these challenges to help the Biobank reach its full potential.

Proposed Solution: The Cancer Moonshot Biobank enrolls patients receiving standard of care cancer therapies, with a focus on longitudinal collection of biospecimens and clinical data from 1,000 participants. Clinical data collection from participating sites in the U.S. is managed through a central system, Medidata RAVE. Data standards such as SnoMed (Systematized Medical Nomenclature for Medicine–Clinical Terminology) and MedDRA (Medical Dictionary for Regulatory Activities) are used in RAVE's Case Report Forms for histology and diagnosis data coding. Other terminology resources such as CaDSR (Cancer Data Standards Registry and Repository) are applied for collecting other clinical, demographic, social, and environmental data along with biospecimen‐specific data. A stop‐word algorithm is used to clean up cancer treatment data by removing “noise” (dose, frequency, free text) from the therapy names. All brand and generic drug names are mapped to standard names for clinical drugs in the RxNorm database (https://mor.nlm.nih.gov/RxNav/). Integrated study data are de‐identified and assigned with Public IDs and then mapped to specific models for submission to public data repositories.

Conclusion: Utilizing data standards and performing data harmonization ensures a high level of interoperability for the Biobank dataset and facilitates data submission to public data repositories. The Biobank's comprehensive clinical data has been released from the database of Genotypes and Phenotypes (dbGaP) in batches since 2022, while the Biobank continues to collect longitudinal specimens and associated data. Following each dbGaP release, accompanying image data is released from The Cancer Imaging Archive and the Imaging Data Commons, part of the Cancer Research Data Commons. Additional data releases will also take place in the CRDC's still‐developing Clinical Trials Data Commons.

PL‐01 Optimization of Buffy Coat Removal Using Automated Liquid Handling Systems

C. Chow¹, S. Lim², H. Teo¹, K. A. Wong¹, V. Guneta², F. Gan¹, C. Eng¹

¹National University Health Systems (NUHS), Singapore, Singapore, Singapore, ²Cryomics Pte Ltd, Singapore, Singapore, Singapore

Buffy coat isolation are usually performed manually. However, this can be time‐consuming and labour‐intensive, and is prone to variation between operators. Automated liquid handling systems can be used to facilitate buffy coat isolation. These systems offer a number of advantages over manual methods, including increased speed, accuracy, and reproducibility. The Tecan Fluent is a versatile automated liquid handling system that can be used for a variety of tasks, including buffy coat isolation. The default setting for buffy coat isolation on the Fluent is a 5 × 5 × 5 grid. However, it has been suggested that a 9‐point octagonal pipetting pattern may be more efficient for buffy coat isolation, as it better aligns with the circular shape of the blood tube. To compare the efficiency of the 5 × 5 × 5 grid and 9‐point octagonal pipetting patterns for buffy coat isolation, a study was conducted using the Tecan Fluent using whole blood samples in STRECK RNA tubes. The results of the study showed that the 9‐point octagonal pipetting pattern was more efficient for buffy coat isolation than the 5 × 5 × 5 grid pipetting pattern. This is likely due to the fact that the octagonal pattern better aligns with the circular shape of the centrifuge tube, which minimizes the amount of buffy coat that is left behind.

PL‐02 Generation Victoria's Automated High Throughput Biosample Processing

K. Powell¹, J. Feng¹, J. Harker¹, F. Abary¹, Y. T. Mangwiro‐Budahazy¹, T. Frugier¹, J. Smith², R. Filonzi², V. Marrazzo², R. Saffery¹

¹Murdoch Children's Research Institute, Parkville, Victoria, Australia, ²Bio‐Strategy Pty Ltd, Melbourne, Victoria, Australia

Background: Parents of every child born in Victoria over a 2‐year period (from October 2021) were offered the chance to participate in the Generation Victoria (GenV) initiative, providing a range of data and biosamples. GenV's primary objective is to create a large, whole‐of‐state birth and parent cohort for discovery and interventional research. GenV is an Open Science platform, available to all researchers internationally. Large numbers of biosamples necessitated high throughput processing systems, including automated liquid handling instruments and a fully automated ‐80°C storage system to ensure biosamples could be processed, stored, and retrieved efficiently with reliable sample tracking at all stages.

Methods: Hamilton's STAR and STARlet liquid‐handling instruments were used for high throughput sample processing of serum, saliva, and breastmilk. Specific methods were implemented for each sample, developed and tested in conjunction with Bio‐Strategy and GenV. Samples were aliquoted into FluidX tubes (variable volume) and stored in the Hamilton BiOS Automated ‐80°C Storage System.

Results: Using liquid handling instruments allowed GenV to process hundreds of serum, saliva, and breastmilk biosamples each day which would not have been possible with manual methods. At the completion of each processing run, an output file with aliquot information was automatically integrated to OpenSpecimen LIMS. Since June 2022, 94% (54,349) of saliva samples have been processed on the STAR, since April 2002 74% (63,000) of serum samples, and since November 2022 60% (3,848) of breastmilk samples have been processed on the STARlet. All GenV saliva, breastmilk, and stool aliquots (128,211) and approximately 80% of serum aliquots (241,167) are stored in the BiOS.

Conclusions: The use of automated liquid handling instruments for the high‐throughput processing of large numbers of a range of biosamples has been hugely successful for the GenV initiative. Without this level of automation, processing times would have increased substantially along with the time taken to store the biosamples at ‐80°C. This would invariably impact biosample integrity which would likely have been compromised. Furthermore, the ability to have biosample and aliquot information automatically integrated from the liquid handling instruments to OpenSpecimen LIMS eliminated many hours of manual data entry and possible data entry errors.

PL‐03 Automation of Liquid Nitrogen Freezer for Cryopreservation of Human Biospecimens

S. Kaushal, B. Wishart, J. Rull, P. Sharma, A. Garcia, E. Masmila, A. Molinolo

Moores Cancer Center Biorepository, University of California San Diego, La Jolla, California, United States

Introduction: The Biorepository at Moores Cancer Center, University of California San Diego, is a College of American Pathologists (CAP)‐accredited core. Here, we describe the steps to implement an automated, sustainable storage system. Adequate preservation of biospecimens has been critical to obtaining reliable and reproducible results in genomics, transcriptomics, proteomics, developing Patient‐Derived Xenograft models, immune profiling, and many other assays. Biological assays that depend on biospecimens stored in liquid nitrogen (LN2) at ‐190°C can be sensitive to transient temperature changes. Updating our manual cryogenic storage system to the automated BioStore™ III Cryo –M‐42 System (NIH Grant, R‐24‐ Modern Equipment for Shared‐use Biomedical Research Facilities: Advancing Research‐Related Operations) has significantly improved storage efficiency, safe handling, GMP support, LIMS, Access Control, etc., resulting in the best possible tissue preservation quality.

Method: Installation, temperature mapping, and training of all personnel was completed before use, and verification of training documentation was obtained. Step‐by‐step workflow was developed. To maintain ultra‐low temperature during transit, CryoPod™ Carriers and the CryoPod™ filling station was installed, and training and workflow was developed. All the standard operating procedures and workflows are CAP compliant.

Discussions: The BioStore™ III Cryo –M‐42 System was successfully implemented and in use starting September 2023. In the past four months, this automatic LN2 freezer has been used to access and store acquired human solid tissue samples. So far 0.54% of the space is occupied, 121 aliquots have been stored. The CryoPod™ carriers and filling station have proven to be instrumental in maintaining temperature during transit. In contrast, a manual LN2 freezer's handling exposes samples to transient changes of temperature when the lid is opened multiple times. In addition, it poses a risk to expose users to low levels of oxygen and frost burn. The BioStore™ III automated storage system combines sample protection, user's safety, and accessibility of a high‐efficiency LN2 freezer with advanced automation features such as real‐time inventory control and cold‐chain management. This system provides a significantly improved workflow for LN2 storage over manual LN2 freezers.

PM‐01 The Mathison Centre Neurogenetics Biobank and Advancing in Precision Mental Health

S. Shaheen^1,2

¹Medical Genetics, University of Calgary, Calgary, Alberta, Canada, ²Physiology and Pharmacology, University of Calgary, Calgary, Alberta, Canada

Background: The Matheson Centre Neurogenetics Biobank is an academic health research biobank within a neurogenetics research network that includes international clinical collaborators, hospitals, research institutes, and community‐based studies. The aim of the biobank is to support gene discovery and knowledge translation in child and youth mental illness and to develop next‐generation research for precision medicine approaches that will contribute to prediction, prevention, and early intervention in these child and youth mental health.

Method: Our biobank system features state‐of‐the‐art technology; controlled rate freezing, sample storage, and transfer; ethics and biosafety; data preservation; documentation; and consultation. As an ongoing development process, the Matheson Centre Neurogenetics Biobank is currently focusing on two major areas: 1) developing an outline of the types of bio‐specimens (saliva, blood, buccal swab) regularly collected, stored, retrieved and distributed in a biobank (https://www.bcplatforms.com) system and the procedures involved with strict standard operating procedures to ensure sample quality fits the purpose of use, and 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. Projects include:

Genetic and Environmental Influences on Behaviour and Cognition in Childhood Neuropsychiatric Disorders.

Conclusion: To date, our biobank has successfully stored 4,062 out of 5,455 clinical bio‐specimens (DNA from blood and saliva) from five different sites. Our biobank system has also established a database system focused on sample tracking, phenotype‐genotype linkage, and health information. The Matheson Centre 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.

PM‐02 Developments in A Local Human Research Biobanking Operation in Louisville, Kentucky

I. D. Sithu, B. L. Blair, D. Riggs, S. Srivastava

Environmental Health Institute, University of Louisville, Louisville, Kentucky, United States

The biobanking core at the University of Louisville Environmental Institute maintains the inventory of human samples. Since its inception in 2014, the Core has grown exponentially. For human studies, the Core collected approximately 500 specimens in 2014 and this number swelled to 123,000 in 2022. Overall, the Core has biobanked more than 400,000 human specimens. These include a variety of blood plasma samples (n = 178,000), serum (n = 61,000), urine (n = 141,000), toenails, hairs, oral swabs, etc. Unlike many laboratories which use a laboratory information management system for managing both patient samples and clinical data, we use it mainly to manage and track our samples with deidentified patient information. This eases the burden of safeguarding protected health information of patients and assigning role‐based data access. The patient information and clinical data are securely maintained separately on REDCap. However, we experience downsides of keeping sample and samples measures data independently. They include lack of efficient coordination among specimen collection, management, and sample measures. In recent years, we have taken a few measures to address these challenges. These include regrouping of sample data into smaller groups, maintaining uniformity in label printing format and periodic sharing of updated sample inventory reports. We are striving towards bringing harmony among sample data, clinical data, and all sample measures.

PM‐03 Four Pillars of Ukrainian Biobank Resilience during Wartime

O. Sulaieva^1,3, N. Syrovetnyk², O. Dudin^2,4

¹Medical Laboratory CSD, Kyiv, Ukraine, ²CSD BIO (LLC CSD Health Care), Kyiv, Ukraine, ³Bogomolets National Medical University, Kyiv, Ukraine, ⁴Shupyk National Healthcare University of Ukraine, Kyiv, Ukraine

Statement of the Problem. The ongoing war in Ukraine is recognized as a humanitarian disaster that heavily affected the healthcare and research systems, energetic infrastructure, and economic milieu, impacting various aspects of biobanking. War‐associated threats, including military actions, attacks on energetic infrastructure, and complicated logistics aggravate the preexisting barriers to biobanking development in Ukraine. What measures are needed for continuous biospecimen‐associated operations and research?

Proposed Solution. To answer this question, we provide the experience of a private Ukrainian research biobank (CSD BIO), associated with the large pathology laboratory (CSD LAB). Primarily the emergency plan was updated and adjusted to the threats of the war and socioeconomic circumstances to safeguard staff safety, physical and cyber security, a continuous supply chain, and robust logistics. Energy backup and autonomous water supply systems were crucial to keep working under energy cuts. Next, alignment with the international guidelines and best practices enabled us to meet research community expectations concerning legal, ethical, and quality assurance issues. Possessing the multi‐collaborative model CSD BIO cooperates with numerous investigators which enables keeping the scale of sample collection and geographic diversity. Linking with the fully automated and ISO15189‐certified laboratory ensures high‐quality specimen and data accuracy. Besides access to the full range of laboratory services, including clinical chemistry, immunochemistry, microbiology, pathology, and molecular genetics, provides additional opportunities to facilitate biomarker discovery. Barcoding and sample management system ensured precision in sample handling and accelerated efficiency. Finally, lean management implementation minimized waste and enhanced operational productivity.

Conclusions: The four main pillars ensuring robust operational activities and resilience of biobanking in Ukraine include: 1) an effective emergency plan, 2) alignment with international guidelines and best practices, 3) link to laboratory facilities, and 4) lean management application.

PM‐04 WITHDRAWN

PM‐05 Evaluation of Turnaround Time (TAT) for Issuance of Biospecimens: An Experience of National Tumour Tissue Repository, Tata Memorial Centre, Mumbai, India

S. Desai¹, M. Kulkarni¹, L. Choughule¹, C. Madiwale², M. Sengar¹, M. Joshi¹, S. Menon¹, S. Zingde¹

¹Tata Memorial Centre, Mumbai, Maharashtra, India, ²P. D. Hinduja Hopsital and Medical Research Centre, Mumbai, Maharashtra, India

Background: National Tumour Tissue Repository (NTTR) was established as the first organized biorepository in India in the year 2005 at the Tata Memorial Centre (TMC) to provide adequate and properly preserved tissues to researchers for their Institutional Ethics Committee (IEC)‐approved projects. A separate NTTR Technical Authorization Committee (NTAC) was constituted in the year 2011 to monitor the disbursement of biospecimens and associated clinical data to TMC and non‐TMC investigators. The purpose of the study is to evaluate TAT for the issuance of the biospecimens.

Methods: Check list of documents required is provided to the investigators. NTAC meetings are scheduled as per the receipt of the requests from the investigators. Scanned copy of the duly filled and signed specimen requisition form is obtained from the researcher along with scanned copies of IEC approval, soft copy of IEC‐approved project proposal, and Continuing Review Application (CRA) approval by IEC. Material Transfer Agreement and Memorandum of Understanding are sought in cases of TMC collaborative projects and non‐TMC investigators. The requests for biospecimens are discussed by circulation on email by NTAC. Responses from all the members of the NTAC are recorded and biospecimens are disbursed as per the consensus decision. TAT as per NTTR standard operating procedure is 15 working days. For the purposes of this study, the date of acceptance of requisition form along with requisite documents was noted. TAT was calculated as number of working days elapsed between the date of submission of requisition form and the date of last reply from the NTAC. The reasons for the delay were recorded.

Results: In a span of 12 years (2011‐2023), 87 NTAC meetings were conducted for 119 requisitions for 78 research projects. The Program Manager coordinated the communication between NTAC members and the requester of the biospecimens. Average TAT was 7.86 working days with a range of 1‐34 days to arrive at a final NTAC decision. The delay was attributed to noncompliance of the request with respect to IEC approved project proposal, inadequate documentation by the requester, and other reasons, e.g., other professional commitments of NTAC members.

Conclusion: NTAC facilitated the distribution of biospecimens in an equitable, ethical, and efficient manner. Good governance and timely communication with investigators ensure transparency and efficiency for issuance of appropriate biospecimens and clinical data.

PM‐06 A Centralised Facility Designed to Futureproof Research, But How Secure and Disaster Ready Is It?

G. Reaiche‐Miller, A. Netting

The Adelaide Biobank, Division of Research and Innovation, The University of Adelaide, Adelaide, South Australia, Australia

Statement of the Problem: Ultra‐cold freezers are utilised across universities for the storage of human, animal, and environmental specimens. These specimens are used in basic research or clinical trials and form part of collections or “small biobanks.” The effective management of these is a matter of increasing concern to universities as it carries significant financial and research risks as ultra‐cold freezer failure ranks as the third most common adverse event. The diverse and valuable nature of these samples, often expensive and irreplaceable, highlights the need for effective management.

Proposed Solution: A centralised facility to efficiently manage the storage of these materials is critical to reduce the financial burden and research risks. However, such a centralised facility must have effective risk management, emergency, and disaster response plans for both the samples stored and the data associated with such samples. The University of Adelaide implemented the Adelaide Biobank, a purposely built central, secure, comprehensive, state of the art PC2 facility currently housing 62 ultra‐cold freezers. It is equipped with multiple redundancies, alarm monitoring, extensive preventative maintenance, and emergency response plans.

There are some important factors to consider when developing a successful emergency plan: risk identification, risk assessment, risk mitigation, emergency preparedness, emergency response, and emergency recovery. With these in mind, The Adelaide Biobank developed a university‐wide cold storage management policy that includes: the use of the centralised facility for the storage of high‐risk material, the use of a laboratory information management system to catalogue the material stored in all ultra‐cold freezers, and guidelines for the physical management and monitoring of all ultra‐cold freezers.

Conclusion: Since the implementation of the Adelaide Biobank and the introduction of the university‐wide cold storage management policy, the number of research interruptions and insurance claims resulting from freezer failures have dramatically reduced, with only one confirmed claim in the last 8 years. Due to its success, the policy has been updated to include specimens stored in liquid nitrogen vessels and ‐20°C‐degree freezers and the demand for extra storage has increased. As a result, The Adelaide Biobank is expanding to include cryogenics and ‐20°C‐degree storage as well as sample processing and other biospecimen services.

PM‐07 Establishing A Transparent Costing Model: Analysis of Time, Expenses and Costs of the Victorian Cancer Biobank

J. B. Hess¹, L. Graham^2,1, S. Hume^3,1, J. Marquez^4,1, A. J. Mountain^5,1, S. Cauberg^6,1, S. Higgins¹, W. Ng¹

¹Victorian Cancer Biobank, Cancer Council Victoria, Melbourne, Victoria, Australia, ²Melbourne Health Tissue Bank, The Royal Melbourne Hospital, Parkville, Victoria, Australia, ³Eastern Health Tissue Bank, Box Hill Hospital, Box Hill, Victoria, Australia, ⁴Monash Health Tissue Bank, Monash Hospital, Melbourne, Victoria, Australia, ⁵Austin Health Tissue Bank, Austin Hospital, Heidelberg, Victoria, Australia, ⁶Peter Mac Tissue Bank, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Clear costing of services is critical for business development, addressing misconceptions of overpriced services and ultimately achieving financial sustainability of a biobank. Currently, there is lacking industry consensus and benchmarking on cost recovery models for biobanks. We performed a costing analysis to establish a harmonised cost schedule, encompassing fixed and variable costs as well as funding‐associated subsidies.

The Victorian Cancer Biobank (VCB) is a government‐funded, multi‐site consortium that offers a wide range of services which can be categorised as archival specimens, prospective collections, and clinical trial support. All services offered also have associated complex data requirements. The previous cost recovery model was derived from provision of archival specimens and no longer fit‐for‐purpose as the VCB's services increased in scope and complexity.

To re‐establish the cost recovery model for the VCB, three key steps were taken. Firstly, the time for each activity was logged across sites for a month, including service and administrative tasks. Secondly, the annual operating expenses were collated and analysed alongside site activity to differentiate fixed and variable costs. Finally, the actual cost per services were calculated and taking appropriate subsidies into account, a cost schedule was established.

Analysis of our operations and associated costs highlighted key considerations. Project administration was a significant cost previously not accounted for. Especially with bespoke prospective collections, the involvement of our Consortium's tissue banks can vary considerably, and case‐by‐case assessment is still required. A substantial subsidy was necessary to align with the program purpose that includes supporting academic research. Balancing academic sector affordability and requirements with overall biobank sustainability requires clear communication with stakeholders to ensure awareness of the costs of services and subsidies involved. In conclusion, the systematic review of VCB services has resulted in a transparent and comprehensive costing of services for our stakeholders.

PM‐09 Developing A Business Plan for a Rare Pediatric Eye Cancer Biobank

K. Flegg¹, R. Noronha¹, A. Mallipatna^1,2, S. O'Donoghue^3,4, T. Tarling^3,4, P. Watson^3,4, H. Dimaras^1,5

¹Ophthalmology and Vision Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada, ²Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada, ³Biobanking and Biospecimen Research Services, Deeley Research Centre, BC Cancer Victoria, Victoria, British Columbia, Canada, ⁴Canadian Tissue Repository Network, Vancouver, British Columbia, Canada, ⁵Ophthalmology and Vision Sciences & Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

Background: The first rare‐pediatric eye cancer (R‐PEC) biobank was established at The Hospital for Sick Children (SickKids, Toronto, Ontario). The R‐PEC Biobank systematically collects nationally and internationally sourced biospecimens, clinical data, and images. Increasingly, biobank financial and operational sustainability is found to be associated with utilization of a well‐defined business plan. To this end, we aimed to develop a business plan for the R‐PEC Biobank.

Methods: A Business Plan Working Group was formed including key leadership and staff of the R‐PEC Biobank. Biobank business plan consultants were hired to advise the working group. A framework for the business plan, aligned with established guidelines and best practices, was developed. Working group members drafted sections of the business plan which were then iteratively revised until consensus was reached.

Results: The resultant business plan included mission and vision, key elements and guiding principles, governance, management, operations, financial projections, key performance indicators, accrual targets, marketing and communication plan, implementation plan, and risks and associated mitigation strategies. Development of the R‐PEC Business Plan was uniquely complicated owing to the rarity of the conditions of interest, commitment to authentic patient engagement across all areas of the R‐PEC Biobank, and the atypical milieu in which the R‐PEC Biobank operates, specifically as a subset of a broader pediatric ophthalmology biobank residing within the institutional SickKids Central Biobank.

Conclusions: The business plan will be shared on the R‐PEC Biobank website and refined by internal and external oversight entities including the R‐PEC Patient Advocate Committee. The R‐PEC Business Plan will be critically appraised by the Principal Investigator and R‐PEC Biobank Manager after each of the first 3 years of implementation.

PM‐10 Creating a Data Sharing Plan for the Cancer Moonshot Biobank

V. Gopalakrishnan¹, A. Mohandas², P. Guan¹, J. McLean², M. A. Jensen², H. J. Ellis³, S. McDermott², L. Agrawal¹, J. W. Wanyiri², A. Rao¹, P. M. Williams², H. M. Moore¹¹

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland, United States, ²Leidos Biomedical Research, Inc., Frederick, Maryland, United States, ³Biobanking Without Borders, LLC, Durham, North Carolina, United States

Statement of the Problem: Timely access of data collected in biobanks and clinical studies is critical in improving diagnostics and therapeutics for complex diseases such as cancer. One of the Cancer Moonshot^SM initiative's key recommendations is to create a national data ecosystem to facilitate prompt data sharing and analysis. A rigorous data sharing policy is in place for National Cancer Institute (NCI)‐supported Cancer Moonshot research projects including the Cancer Moonshot Biobank (Biobank). The Biobank is collecting longitudinal biospecimens and associated structured data from over 1,000 cancer patients undergoing standard‐of‐care treatments. A well‐defined data sharing plan and informatics infrastructure was needed to align with Moonshot requirements.

Proposed Solution: The Data Management and Sharing plan for the Biobank was created with expertise from an integrated project team comprising information systems and bioinformatics experts from across NCI. An integrated information technology (IT) infrastructure was implemented by the Biobank IT team to facilitate the collection, management, and sharing of biobank data. Raw data assembled in an in‐house data management environment is extracted, transformed, standardized, and quality controlled to ensure that a robust data product with no personally identifiable information (PII) shared. The IT team considered data types, type of data access, researcher needs, and resources available in identifying an existing resource, the database of Genotypes and Phenotypes (dbGaP), for sharing the Biobank's clinical data, limited biospecimens, and sequencing data; the study's radiological and histological images are shared at The Cancer Imaging Archive. Data are also being released to new NCI data‐sharing platforms as they come online, including the Clinical Trials Data Commons and the Imaging Data Commons. A new online catalog is in development for displaying an inventory of available biospecimens to researchers. Data in these different platforms linked through public IDs will enable researchers to navigate across platforms to retrieve relevant data associated with the biospecimens.

Conclusion: Providing structured data that cater to the needs of a wide range of researchers can facilitate effective and meaningful data analysis. The Cancer Moonshot Biobank data is made available in a timely manner through National Institutes of Health data‐sharing platforms with the aim to accelerate research in cancer drug resistance and sensitivity.

PM‐11 The China National GeneBank: To Make Genetic Resources Owned by All, Completed by All, and Shared by All

CNGB

China National GeneBank, Shenzhen, Guangdong, China

Over the past decades, there has been a rising global attention towards genetic resources. In China, genetic resources have acquired official recognition as a national strategic resource. Though it took off from a relatively late starting point, China has been actively catching up with its global peers in storing genetic samples and data. Evidencing this commitment, in the year 2011, China approved the establishment of its nation‐level integrated gene bank, the China National GeneBank (CNGB), with the responsibility for its construction and operation entrusted to BGI‐Research.

CNGB was officially launched in September 2016. With the aim of to become an internationally renowned platform with capabilities that foster the advancement of science and technology, CNGB has established a comprehensive biorepository, a digitalization platform, and a bioinformatics data center, covering every phase of the biosample lifecycle. This presentation expounds upon the detailed information of our integrated biosample repository with tens of millions of storage capacity, the sequencing platform with petabase level annual output, and the bio‐informatics data center with petabyte level storage.

As one of the key scientific infrastructures in Shenzhen, CNGB opens its facilities and renders public platform services for life science research to universities, research institutions, enterprises, and other stakeholders through its open access and resource‐sharing mechanism. Additionally, CNGB has launched the China National GeneBank DataBase, a unified platform built for biological big data sharing and application services to the research community that has substantively contributed to an escalating number of research projects to publish papers in international journals.

With all the efforts support the development of life sciences and bio‐economy in China and to take the lead in the industrial advancement and innovation, CNGB is progressing towards the realization of its vision for genetic resources to be “Owned by All, Completed by All, and Shared by All.”

PM‐12 Transitioning Workflows into an Electronic Quality Management System (e‐QMS): The “Tracked Changes” of a Biobanking Implementation Journey

T. Everett¹, A. Rudge¹, S. Higgins², S. Cauberg¹, C. Carolan¹, S. Fox¹

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

Background: The Peter MacCallum Tissue Bank (PMTB) is part of the Victorian Cancer Biobank (VCB), a consortium of five hospital‐embedded biobanks in Melbourne that aims to distribute high‐quality human biospecimens to researchers globally. PMTB historically enacted a variety of concurrent workflows requiring close collaboration with internal hospital partners and stakeholders, under the governance of the Research Division. Recently, with PMTB governance being transferred to PM Pathology, an opportunity to upgrade workflows to a fully accredited Quality Management System using electronic software (e‐QMS) was identified. The rationale was to increase interoperability, efficiency, and consistency throughout PMTB service delivery and standard compliance.

Methods: PM Cancer Centre Pathology e‐QMS was extended to include Tissue Bank workflows. Appropriate training of staff and standard operating procedure (SOP) writing guidance followed. Existing SOPs were refined, and new SOPs were developed and uploaded. Where workflows required multiple departments, SOPs underwent collaborative review. Upon completion of e‐QMS transition, internal audits were conducted to ensure critical workflows and equipment remained well documented.

Results: Over approximately 20 months, PMTB successfully transitioned workflows to an e‐QMS, incorporating SOPs, forms, and equipment records. Benefits continue to be realised, including:

Enhanced procedure delivery consistency for services offered at a pathology‐integrated tissue bank and confidence of training.

While advantageous, reliance on e‐QMS brings new challenges such as network/system outages. PMTB negates this risk through cross‐training of staff and hard copy access for critical procedures.

Conclusion: Despite a gradual implementation, PMTB has successfully increased productivity of the biobank and enhanced workflows through an e‐QMS. The improved quality management at the biobank creates additional opportunities such as pursuing further certifications or ISO‐accreditation in the future.

PM‐13 Rethinking Biobanking – A Cross‐Institutional Approach to Enhance Research Cohort Diversity and Accessibility

D. Villanueva¹, K. A. Wong², W. Ng¹, C. Eng²

¹Victorian Cancer Biobank, East Melbourne, Victoria, Australia, ²Singapore Translational Cancer Centre, Singapore, Singapore

Statement of the Problem: Researchers often face significant challenges in accessing diverse and sufficient cohorts for their studies due to the prevalent siloed approach in biobanking. This issue is further exacerbated by the limited visibility of specimens across biobanks, forcing researchers to liaise with multiple biobanks to fulfil their study criteria. Furthermore, the variability in standards and protocols for storage, tissue, and data collection among biobanks adds additional layers of complexity to the research process.

Proposed Solution: To address these challenges, the Singapore Translational Cancer Consortium (STCC) and Victorian Cancer Biobank (VCB) formed a collaboration with an initial stage to establish cross‐institutional specimen catalogues. This collaborative effort aims to enhance the accessibility and visibility of available specimens and associated clinical data, simplifying the request process for researchers whilst ensuring a harmonised standard of tissue quality and clinical data augmentation.

Key components include defining a minimum dataset and associated metadata, data mapping, secure data transfer, integration mechanisms, and a streamlined triage and administrative process.

Existing catalogues will be refined to showcase key data elements through a user‐centric interface, enabling researchers to explore, apply data filters, and obtain updates into inventories.

All communications regarding specimen requests will be coordinated by the biobank hosting the catalogue to the custodians of the samples of interest. However, oversight, approval, and logistics will remain under the jurisdiction of each participating biobank.

Conclusion: The establishment of cross‐institutional specimen catalogues is the first step in improving visibility and accessibility of specimens, enhancing researchers' experience in seeking valuable specimens for their scientific work, ultimately contributing to improved patient outcomes. This collaboration between STCC and VCB holds potential to foster increased cooperation across biobanks and national borders, and to lay the foundation for an integrated international consortium of biobanks. The formation of such a consortium would serve as a consolidated platform for researchers and biotechnology companies, catering to a broad spectrum of research needs whilst promoting a collaborative global research ecosystem.

PN‐01 PBMC Isolation and Storage: New Service Introduction in an Academic Biobank

R. Singh¹, T. Delao¹, D. Price¹, N. Garcia¹, R. Ibrahim¹, S. L. Murphy¹, T. Linston¹, P. McShane¹, D. Bernard²

¹HMRI Biorepository, Houston Methodist Academic Institute, Houston, Texas, United States, ²Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas, United States

Background: Houston Methodist Research Institute Biorepository is a system wide biorepository for the Houston Methodist Hospital System and Academic Institute in Houston, TX. The biorepository recently launched a new service for isolating and storing peripheral blood mononuclear cells (PBMCs) for research applications.

Methods: The HMRI Biorepository decided to launch PBMC isolation and storage service in July 2022 to cater to the demand of institutional researchers once it received a request for PBMC isolation and saw future potential of this service. A dedicated team of two staff was set up to take charge of developing this service. An initial literature review on various methods of PBMC isolation was conducted. The team was designated to learn PBMC isolation process being performed at another institutional research lab. This lab used BioRad TC20 cell counter for performing total and viable cell count. The biorepository staff learned the PBMC isolation process at this lab and completed the first request based on their protocol with manual Ficoll‐Hypaque isolation technique. The Executive management was presented with a plan to further develop this service in‐house. Funds were made available and a TC20 cell counter was purchased by the biorepository. Various isolation methods, including the manual as well as the automated magnetic bead based, were explored. The manual Sepmate tube isolation method was chosen after due consideration. Two dedicated biorepository staff spent hours learning the details of the Sepmate tube isolation method with a lot of help from a vendor staff. The staff worked hard and diligently on almost 30 to 40 healthy blood samples over a period of 2 to 3 months to fine‐tune the process. The biorepository also enrolled for the ISBER‐IBBL PBMC proficiency testing program to ensure quality of the service.

Results: The HMRI Biorepository recently finalized its SOPs for PBMC isolation and storage services. The ISBER‐IBBL PBMC proficiency testing for counting for viability testing has been cleared with an A rating. A revenue‐generating clinical trial is already in the biorepository's fund with the PBMC isolation process being vetted and approved by the commercial sponsor. Other protocols requiring the service are already in the pipeline.

Conclusions: The process of developing a new service consumes a lot of time, resources, and hard work. A dedicated team, stakeholder support, and sustained training effort is necessary for introducing a new quality biobanking service.

PN‐02 WITHDRAWN

PN‐03 Establishing Biological Material Quality Harmonization in Qatar Biobank

M. Markovic Bordoski, L. Hannigan, E. Al Khayat

Qatar Biobank, Qatar Foundation, Doha, Ad Dawhah, Qatar

Problem: The reputation of any biobank can be built on a foundation of quality. Biological material integrity, reproducibility, and consistency are key to achieving overall quality harmonization.

The biobanking industry has identified that biological materials need to be managed using standard operating procedures from industry‐recognized quality, scientific, technical, business, and ethical/legal requirements. However, with no defined quality acceptance criteria, the perception of quality interpretation can oscillate from biobank to biobank resulting in variable biological material outcomes.

Proposed Solution: Qatar Biobank is certified for ISO 20387: 2018 and accredited for College of American Pathologists Biobanking, as well as ISO 9001: 2015 for Quality Management System. A cross‐standard review relevant to quality was made and a gap analysis was performed to identify areas of compliance, partial compliance, and noncompliance. Consequently, the identified need for adherence has extended the overall quality management approach covering the quality requirements of biological materials and their lifecycle from pre‐analytical through to post‐analytical phases. The long‐term impact of harmonized outcomes has been realized in Qatar Biobank through a series of quality control measures. Targeted QC checks were placed to monitor all applicable areas in the biological material lifecycle aiming to measure, evaluate, and reduce day‐to‐day operational variability. This has been achieved by capturing the protocol variables, repeatability, reproducibility, acceptance criteria, reference ranges, and applicable attributes relatable to sample types such as: plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMCs), and extracted nucleic acids (DNA and RNA) with defined analytical and functional quality control metrics. Implemented quality control measures become an integral part of compliant ISO 20387: 2018 QC report, bringing to the end user assurances about the quality of the biological materials from Qatar Biobank.

Conclusions: The adage “rubbish in and rubbish out” has never been more relevant. Poor quality biological materials will only result in poor research with results that are not reproducible or consistent. Adhering to and implementing quality criteria that result in harmonized outcomes will be beneficial globally for the improvement and development of research and precision medicine outcomes.

PN‐04 Manual of Biobank Quality Management – A Cutting‐Edge Tool for Biobanking Quality Standards Implementation

J. Glenska‐Olender, A. Matera‐Witkiewicz

Wroclaw Medical University Biobank, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, Wroclaw, Dolnoslaskie, Poland

Background: The importance of quality in professional biobanking is not needed to be convinced. Nowadays, a great attention is paid whether partner or institution meets the quality standards. Biobanks are performing internal operation rules mostly implemented from the organizations in which they are situated. Due to the disturbances in understanding how the quality system shall be organized and built, the idea for the first version of the Manual of Biobank Quality Management was born.

Methods: The 1st version has been published only in the Polish language. But after extensive reviews within the biobanking community, we decided to prepare another manual based on the first idea of the book. The Manual of Biobank Quality Management is the second updated and completed edition intended to be not only a set of guidelines resulting from the normative regulations, but also a source of practical knowledge. Thus, the Manual of Biobank Quality Management was published in 2023 (eBook ISBN978‐3‐031‐12559‐1) by Springer Link.

Results: The Manual is convergent with ISO20387:2018, but also with ISO9001:2015, ISO19011:2018, ISO 27000:2014, and ISO27002:2013. Additionally, this document is compatible with the recommendations of the OECD, IARC CMTS, and ISBER BP. This book is divided into 15 chapters. Each of them includes the main part containing a substantive contribution referring strictly to the requirements for biobanks, including the ISO 9001:2015 and ISO 20387:2018 along with an indication of references to individual standard points. It also contains a practical section: the most common practices and FAQs. The most commonly used practices section is based on advice, tips, and even ready‐made solutions. In Poland the Manual is recognized as a unified quality guide for the Polish Biobanking Network. Moreover, in 2022 it was implemented in the National Medical Research Agency for all non‐commercial clinical trials in the biobanking area.

Conclusions: The Manual is friendly in form and content guide for anyone who is just starting their adventure with biobanking or has extensive experience in this field and only wants to complete their knowledge. The Manual pointed out that not only is the quality of biological material important, but also the quality of associated data and information regarding them. It is anticipated that this approach would be effective not only in introducing the international standards to the routine practices, but also raise altogether the quality of clinical research.

PN‐05 It's Not What It Looks Like! Quality Control after Fresh Tissue Procurement

E. Howington, A. Golowiejko, M. Abdelmalak, S. J. McCall

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

Background: The Cooperative Human Tissue Network (CHTN) Southern Division (SD) procures thousands of human tissue samples each year that are stored for future use or released to researchers. Solid‐tissue samples are often prospectively obtained fresh for researchers. Since these fresh samples are often shipped to the researchers immediately for maximum viability, there is less opportunity to confirm the histologic properties of the sample prior to distribution. Mirror‐image quality control (QC) formalin‐fixed, paraffin‐embedded (FFPE) tissue blocks are prepared and histologic assessment is performed after sample distribution in many cases.

Methods: Histologic QC data was available for 3,978 prospectively‐procured tissue samples at CHTN‐SD. Data reviewed for this study included the anatomic site of finding, gross impression, histologic diagnosis, percentage of necrosis (unacceptable if greater than 50%), and percentage of tumor (unacceptable if less than 10%). Errors (gross impression not confirmed at histologic review, inadequate tumor percentage, etc.) were identified, categorized, and counted.

Results: Of the 3,978 samples reviewed, 519 (13%) were considered failures. Of these, 161 (31%) were grossly labeled as tumor samples but no tumor cells were identified during histologic review; most of these were from the breast, colon, liver, and lung. There were 130 samples (25.05%) with more than 50% of necrosis, with the majority being from the lung, kidney, and liver. Samples that were grossly labeled as tumor and contained less than 10% of tumor nuclei histologically were also considered as failures; of these 77 (14.8%) samples, most were from the pancreas, colon, and liver.

Conclusions: Quality control utilizing mirror‐face FFPE histologic assessment for fresh or frozen tissue samples has been a pillar of the CHTN since its inception in 1987. This is because pathologists are aware that gross assessment of disease is not a substitute for histologic review. This study highlights commonly known errors (such as low tumor cellularity in pancreatic cancer) which may not be improved through intervention, but also shows errors (such as procuring pre‐cancerous colon polyp instead of invasive tumor) that may represent the prosector's conservatism for which intervention may prove beneficial. These analyses create conversations and collaborations between surgical pathology prosectors and research procurement teams to improve the quality human tissue for research.

PN‐06 Quality and Integrity of Biospecimens and Data Are at the Core of All the Processes of the Global Integrated Analytical Biorepository

M. Sheldon¹, Y. Ding¹, J. Moore¹, A. Jadali¹, B. Roylance¹, H. Tsimiklis², M. Southey², S. Nahas¹, R. Grimwood¹

¹Sampled, Piscataway, New Jersey, United States, ²Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia

The demands of the rapidly expanding fields of clinical research, cell and gene therapy, and drug development call for a new operational paradigm, with the biorepository evolving from the conventional storage facility to one that incorporates the ability to support the entire processing cycle of the biospecimen and its associated data, with workflows and infrastructure that adhere to the highest standards of quality.

The Global Integrated Analytical Biorepository (GIAB) provides a new pathway in biorepository and biobanking science to advance human health by providing services that are instrumental to the optimization of the quality of biospecimens from the collection phase through blood fractionation, nucleic acid extraction, multiomics analysis and storage. We will consider how the integration of all these services under the GIAB offers unique advantages that manifest themselves in robust data, generated in a timely and economical manner. To achieve this, rigorous oversight of the quality of each process is maintained by adherence to standard operating procedures and a training program. The presentation will focus on specific examples of innovative approaches that have been implemented to establish quality standards, including assembly of sample collection kits, well‐defined sample registration, and accessioning processes that integrate seamlessly with laboratory information management systems, the extensive use of automated systems, and novel analytical and functional assays of nucleic acid quality prior to genomic analysis.

The integrity of the processed biospecimens is safeguarded in a newly expanded laboratory and biorepository facility equipped with extensive backup and regulated storage that exceeds College of American Pathologists Biorepository and ISBER Best Practice standards. When coupled with CLIA‐ laboratory certification, including clinical grade processing and genomics analysis, this unique combination of protocols, instruments, infrastructure, and expertise, all governed by a single uniform Quality Management System, allows the GIAB to support the exacting requirements of the pharmaceutical and biotech industries as well as government agencies such as the National Institutes of Health. The GIAB also facilitates the incorporation of cutting‐edge technologies such as single‐cell RNA sequencing and proteomics to afford its client access to as diverse a portfolio of technologies as possible without having to incur the large capital expenses associated with these. In this way, GIAB evolves and grows with the field and its client partners.