The International Society for Biological and Environmental Repositories Presents Abstracts from Its Annual Meeting “Biobanking: Shaping the Scientific Journey” In‐Person: May 17 – 20,2022 Atlanta,Georgia,USA Virtual: June 14

Abstract

Oral Abstract

O‐01 Biobank Network for Promotion of Utilization of Biobank Toward Realization of Genomic Medicine in Japan

S. Ogishima¹, Y. Murakami², Y. Goto³, T. Morisaki², S. Imoto², K. Matsuda², M. Hirata², H. Yokota⁴, K. Ohneda⁴, F. Nagami⁴, T. Nobukuni⁴, S. Nagaie¹, Y. Miyamoto⁵, K. Hattori³, T. Tomita⁵, E. Noiri⁶, K. Shiraishi⁷, R. Matsumura³, K. Kitajima⁶, S. Kawano⁸, M. Morita⁹, H. Nishihara¹⁰, H. Nakae¹¹, J. Ikeda¹¹, M. Yoshida¹², H. Kohbata¹², M. Muto¹³, S. Matsumoto¹³, H. Tazawa¹³, J. Inazawa¹², T. Tanaka¹², A. Takemoto¹², H. Nishiyama¹⁴, T. Takeuchi¹⁴, T. Takagi⁸

¹Informatics for Genomic Medicine, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Miyagi, Japan, ²The Institute of Medical Science, The University of Tokyo, Minato, Tokyo, Japan, ³National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan, ⁴Tohoku Medical Megabank Organization, Tohoku University, Sendai, Miyagi, Japan, ⁵National Cerebral and Cardiovascular Center, Suita, Osaka, Japan, ⁶National Center for Global Health and Medicine, Shinjuku, Tokyo, Japan, ⁷National Cancer Center, Chuo, Tokyo, Japan, ⁸Toyama University of International Studies, Toyama, Toyama, Japan, ⁹Okayama University, Okayama, Okayama, Japan, ¹⁰Keio University, Shinjuku, Tokyo, Japan, ¹¹Council for Industrial use of Biological and Environmental Repositories, Chiyoda, Tokyo, Japan, ¹²Tokyo Medical and Dental University, Bunkyo, Tokyo, Japan, ¹³Kyoto University, Kyoto, Kyoto, Japan, ¹⁴Tsukuba University, Tsukuba, Ibaraki, Japan

Background: In Japan, we organize the AMED biobank network connecting major biobanks for promotion of utilization of biospecimen and data. Our biobank network consists of seven organizations and 12 biobanks including Biobank Japan, Tohoku Medical Megabank project, National Center Biobank Network (six national centers), Clinical Bio‐resource Center of Kyoto University Hospital, Bio‐resource Research Center of Tokyo Medical and Dental University, Tsukuba Human‐Tissue Biobank Center of Tsukuba University Hospital, and Okayama University Hospital Biobank. We are providing a biobank cross‐search service, which enables researchers to search biospecimen and data in our biobank network. As the use of a biobank cross‐search service has increased, the need for a common application system has grown in both academy and industry.

Methods: We surveyed the needs of the users and examined a common application system to access biospecimen and data in our biobank network. We designed a common application flow and developed a common application form of our biobank network.

Results: We surveyed the needs of the users, and according to the needs, we designed a common application flow of our biobank network as follows:

Biospecimen and data selection using biobank cross‐search system.

Application for use.

Request for confirmation of availability.

Preparation for application.

Central institutional review board.

Application.

We then developed a common application form of our biobank network, covering various biobanks including disease biobanks (tissue biobanks) and population biobanks. Finally, we established the common web application system to apply for use of biospecimen and data in our biobank network.

Conclusion: We developed a common application flow and a common application form of our biobank network. It means we standardized an application flow and an application form of major biobanks in Japan, and we obtained minimum common elements in application procedure to apply for use of biospecimen and data in biobanks. Our biobank network stores over 470,000 donors, over 1,030,000 biospecimens, and over 230,000 analytical data with over 3,500 diseases. Utilization across various biobanks will be promoted by our system, and researches and developments toward realization of genomic medicine will be expected to be accelerated.

O‐02 Improving Efficiency of Blood Procurement with a Real‐Time Approach

A. M. Golowiejko, M. Datto, K. Frankey, S. J. McCall

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

Background: Since its inception, the Duke University Health System (DUHS) BioRepository and Precision Pathology Center (BRPC) has procured and processed thousands of human biospecimens. Utilizing an initial institutional investment designed to establish inventory, the BRPC regularly obtained fresh blood samples from the majority of participants scheduled for cancer surgery prior to 2018. After funding exhaustion in 2018, blood procurement was modified to only collect dedicated research blood samples if there was a co‐existing request for such samples from an investigator. In 2020, BRPC developed the option to recover residual blood from clinical samples obtained from patients meeting criteria after clinical testing was complete. This study will examine the effects of these two workflow changes.

Methods: Blood specimen procurement and distribution data will be analyzed from the time period of 2014 to 2021, which spans the prior and current procurement models. The distribution rate is defined as the number of blood aliquots released by the BRPC for research divided by the total number of aliquots prospectively collected or recovered through the real time approach.

Results: By the end of 2014, 3700 blood samples were procured and banked in BRPC (this includes whole blood, plasma, buffy coat, and serum aliquots). As of the current day, 1.9% of these were successfully distributed to researchers. In 2015, 3,897 additional aliquots were collected and less than 1% of these have been distributed. 3,810 samples were obtained in 2016, 4% have been distributed. Fewer aliquots were collected in 2017 but 10% of those have been distributed. Of the 4,180 samples obtained in 2018, 13.5% were distributed while 7.6% of the samples collected in 2019 and 9% of blood aliquots collected in 2020 were released. A drastic change is seen in 2021 as 32% of the 978 samples obtained have been distributed.

Conclusions: While it is tempting to measure biorepositories by the number of aliquots maintained in their inventory, another widely accepted measure of success is the number of aliquots successfully distributed and used in research. By limiting research blood collections to situations where existing requests for such samples exist, and by incorporating the recovery of excess blood samples from Duke's clinical laboratory, the BRPC has seen increased distribution rates. Absolute numbers of procured and distributed blood aliquots will increase as experience with this new model is gained.

O‐03 Linking the Stability of Clinical Proteins in Blood Plasma to ΔS‐Cys‐Albumin—a Marker of Plasma Exposure to Thawed Conditions

E. Kapuruge^{1, 3}, N. Jehanathan^{1, 3}, S. P. Rogers³, S. Williams³, Y. Chung^{2, 3}, C. R. Borges^{1, 3}

¹School of Molecular Sciences, Arizona State University, Tempe, Arizona, United States, ²College of Health Solutions, Arizona State University, Tempe, Arizona, United States, ³The Biodesign Institute, Arizona State University, Tempe, Arizona, United States

Background: Biomolecular integrity can be compromised when specimens are exposed to improper storage or handling conditions. Measurement of compromised analytes can then lead directly to the generation of incorrect and potentially misleading results—without any indication that this has occurred. We recently introduced a marker of blood plasma/serum exposure to thawed conditions called ΔS‐Cys‐Albumin that quantitatively tracks exposure of plasma/serum to temperatures greater than their freezing point of ‐30 °C. To begin to approximate the percentage of clinical proteins that are destabilized by thawed‐state exposures, we have quantitatively linked ΔS‐Cys‐Albumin to the stability of 21 plasma proteins of clinical interest measured by multiplexed ELISA.

Methods: ΔS‐Cys‐Albumin was measured at nine different time points per exposure temperature in K2EDTA plasma samples from 24 separate donors in aliquots kept separately at 23 °C, 4 °C, and ‐20 °C using dilute‐and‐shoot LC/MS as previously reported. Twenty‐one clinically relevant proteins were then measured at four different time points per sample and temperature using multiplexed ELISA on the Luminex platform. Protein stability was assessed by mixed effects models with correction for multiple comparisons. Coordinated shifts in stability between ΔS‐Cys‐Albumin and several of the 21 clinical proteins across all temperature and time exposures were documented by Pearson correlation.

Results: As expected, ΔS‐Cys‐Albumin dropped from a mean value of 19% to under 5% within 96 hrs at 23 °C, 28 days at 4 °C, and 65 days at ‐20 °C. On average, 5‐6 of the 21 proteins significantly increased or decreased in apparent concentration at each exposure temperature (p < 0.0025 and relative concentration shift of >10%). Considering the protein stability data from all temperatures together, a linear inverse relationship was found between the percentage of proteins destabilized and ΔS‐Cys‐Albumin (r > 0.9; p = 0.004).

Conclusions: ΔS‐Cys‐Albumin is useful for forensically tracking approximate times of exposure of archived plasma/serum samples to thawed conditions (> ‐30 °C). Moreover, it appears to be useful for estimating the percentage of proteins that have been destabilized by exposure to thawed conditions, regardless of what the exposure temperature(s) may have been.

O‐06 Strategies for Generating the Highest Quality Isogenic iPSC Lines

A. Jadali, J. C. Moore

Infinity Biologix, Piscataway, New Jersey, United States

Statement of the problem: Since their initial generation in 2007 human‐induced pluripotent stem cells (hiPSC) have been used to model human development and disease progression, for drug screening and for toxicology testing. However, the diverse genetic background of the human race has hampered the usefulness of iPSC in drug screening and toxicological testing. Currently, controls often consist of age and sex‐matched non‐affected subjects or non‐affected family members. The use of the CRISPR (clustered regularly‐interspaced short palindromic repeats)/Cas system can create isogenic cell lines that will serve as better controls and help eliminate effects that are due to genetic variance rather than a biological mechanism.

Proposed Solution: At Infinity BiologiX we have developed a high‐throughput, cost‐efficient workflow for generating hiPSC from many different types of source cells and using CRISPR/Cas9 to genetically these cell lines, creating isogenic lines. A key aspect of this workflow is ensuring that iPSC lines are 100% edited with no cells containing unedited genome. This is critical as there is potential for unedited cells to have a growth advantage, causing the edited line to revert to the original line. Here we present three strategies (Blunt end cloning, FACS sorting, and next‐gen sequencing) we have used to ensure our edited lines are 100% edited.

Conclusion: Using these strategies, we have generated pairs of iPSC lines that are footprint free and meet all of the criteria necessary to certify the cell lines as pluripotent and suitable for use to better understand mechanisms of human disease and development.

O‐07 NCI's Cancer Moonshot Biobank: Supporting Diversity Through Local Patient Engagement

E. Casas‐Silva¹, S. Remick², A. Breggia², N. Korsen², S. Miesfeldt², J. Bearden³, M. Foust³, A. Curtis³, A. Onitilo⁴, I. Adam⁴, H. Ellis⁵, V. Gopalakrishnan¹, P. Guan⁷, L. Agrawal⁷, M. Jensen⁶, S. McDermott⁶, J. McLean⁶, A. Rao⁷, J. Wanyiri⁶, C. Weil⁷, P. Williams⁶, H. Moore⁷

¹Axel Informatics, Rockville, Maryland, United States, ²MaineHealth Cancer Network, Portland, Maine, United States, ³Upstate Carolina Consortium Community Oncology Research Program, Spartanburg, South Carolina, United States, ⁴Wisconsin NCORP, Marshfield, Wisconsin, United States, ⁵Biobanking Without Borders LLC, Durham, North Carolina, United States, ⁶Leidos Biomedical Research, Inc, Frederick, Maryland, United States, ⁷National Cancer Institute, Bethesda, Maryland, United States

Statement of the problem: Incorporating patient engagement in clinical research provides tangible benefits to patients, as well as to studies themselves. Benefits include identifying barriers to participation, cultivating trust and understanding through transparency and culturally sensitive communication, and increasing participant diversity. Unfortunately, patient engagement is not yet a standard component of most clinical studies, partly due to a lack of awareness of the benefits of engagement, and limited expertise and resources for implementation at the individual site level.

Proposed Solution: NCI's Cancer Moonshot Biobank (Biobank) is a nationwide study to advance research on cancer treatment resistance and sensitivity through the provision of biospecimens collected longitudinally from patients receiving standard of care therapy. Patient and provider engagement is a central component of the Biobank. Patients receive clinical tumor biomarker testing as part of their participation. In addition to return of individual biomarker results, engagement strategies include development of the Biobank engagement website that includes information about the study and allows patient and provider access to individual biomarker reports and signed consent forms via a secure portal. Funding for implementation of local engagement strategies is available to NCI Community Oncology Research Program (NCORP) sites participating in the study. Funding aims to support the Biobank's goals of enrolling participants who represent the racial and ethnic diversity of our nation, as well as increase participation of rural and other medically underserved communities. Sites that receive engagement funding are supported through meetings with other engagement sites in order to facilitate networking as well as sharing of resources and lessons learned. We discuss funded local engagement efforts at MaineHealth, Wisconsin, and Upstate Carolina NCORP sites and discuss lessons learned as well as challenges brought about by the COVID‐19 pandemic.

Conclusions: By funding engagement work at participating Cancer Moonshot Biobank sites, we aim to facilitate adoption of successful engagement approaches across all Biobank sites by demonstrating value, encouraging networking and mentorship, and providing sample frameworks from which to build. We hope this work will also inform patient and provider engagement across all cancer research studies.

O‐09 Biobanking: Strengthening Uganda's Rapid Response to COVID‐19 and Other Epidemics

R. E. Kamulegeya, M. L. Joloba, D. Kateete

Immunology and Molecular Biology, Makerere University, Kampala, Uganda

Introduction: SARS‐CoV‐2 is a fatal disease of global public health concern. Measures to reduce its spread critically depend on timely and accurate diagnosis of virus‐infected individuals. Biobanks can have a pivotal role in elucidating disease etiology, translation, and advancing public health. In this article, we show how a biobank has been a critical resource in the rapid response to coronavirus disease of 2019 (COVID‐19) in Uganda.

Materials and methods: The Integrated Biorepository of H3Africa Uganda established a COVID‐19 biobank. Standard operating procedures for sample and data collection, sample processing, and storage were developed. An e‐questionnaire data tool was used to collect sociodemographic factors. Samples were collected at seven‐day intervals from patients, analyzed for key parameters, processed, annotated, characterized, and stored at appropriate temperatures.

Results: Stored samples have been used in validation of 17 diagnostic kits, the Cepheid Xpert Xpress SARSCoV‐2 assay, as well as a sample pooling technique for mass screening and polymerase chain reaction assay validation. Kits that passed validation were deployed for mass screening boosting early detection, isolation, and treatment of COVID‐19 cases. Also, 10 applications from researchers and biotech companies have been received and approved and 4 grants have been awarded.

Conclusion: The CoV‐Bank has proven to be an invaluable resource in the fight against the COVID‐19 pandemic in Uganda, as samples have been resources in the validation and development of COVID‐19 diagnostic tools, which are important in tracing and isolation of infected cases to confront, delay, and stop the spread of the SARS‐CoV‐2 virus.

O‐10 How Artificial Intelligence Techniques Can Be Employed to Increase the Success Rate for Identifying Datamatrix Barcodes

N. Benn

Ziath Ltd, Pampisford, Cambridge, United Kingdom

Datamatrix barcodes play a key role in tracking and tracing both biological and compound samples. These barcodes are usually lasered onto the underside of sample tubes, and the tubes are stored in racks. Barcode reading is conducted using a barcode reader that scans the bottom of a rack of tubes and decodes all barcodes in one go. This is nice in theory, but there are regular issues with identifying the barcodes on the bottom of the tubes. Ambient lighting, background image noise, and variation in lasering and material quality yield tube barcodes that are often difficult to detect with traditional machine vision techniques. However, it can be noted that a human can always resolve these barcodes, even in adverse conditions. Therefore, it is reasoned that artificial intelligence techniques can be employed to increase the success rate for identifying datamatrix barcodes.

Convolutional Neural Networks (CNNs) are a well understood technique for feature extraction of images. In this work, we take the notion of the CNN and apply it to the new application for locating 2D datamatrix barcodes on sample tubes. The chosen CNN is designed to be very lightweight allowing for quick execution. When compared to the pre‐existing heuristic methods, the CNN approach was almost ten times faster to execute with virtually 100% accuracy.

The CNN is implemented on embedded technology, in this instance a Field Programmable Gate Array (FPGA). FPGAs allow for custom circuity to be created for specific application; due to the custom nature of the implementation, this yields a very high‐speed CNN, faster than can be achieved on a standard PC processor. The inclusion of the FPGA to the system opens new possibilities to the way in which the barcode scanners can be implemented. The power of the embedded FPGA means it is now possible to build a stand‐alone mobile scanner, capable of decoding an entire rack in a sub‐second timeframe while having low power requirements and outperforming a traditional high‐spec laptop or desktop PC.

Future work will build on the current achievements of the project and look to introduce more artificial intelligence techniques into the decoding step of rack scanning.

O‐11 Data Mining Pathology Reports for Crucial Biomarkers for Samples Held in a Biobank

Z. von Menchhofen, D. McGarvey, V. LiVolsi

Pathology and Laboratory, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States

Background: Biomarker (BM) data has become standard in pathology reports. These BM data elements are critical to prognostic and diagnostic implications. Capturing these data elements within a biobank's laboratory management system (LIMS), especially for legacy banked samples, presents two critical problems:

It is extremely labor/cost intensive.

These data are stored in free‐form textual elements within pathology reports (PRs) generated in a clinical setting and are not easily queried by simple programmatic text search.

Method: Our project has expanded a Regular Expression Matching Algorithm software engine (REMA) to search stored PRs for BM data. Since 2001, PRs for all collected Biosamples (45,219 PRs) have been stored within the LIMS. These PRs are preserved as text within the LIMS database. REMA is written in PHP and runs as an autonomous server utility. REMA iterates over selected database elements looking for defined patterns within text‐based elements. Regular expressions searches are stronger than textual search. Text searches look for a concrete and discrete term, whereas a regular expression performs a search based on a pattern and breaks the resultant into constituent elements. In this study, pattern recognition was developed for five BMs within clinical practice that would appear on PRs and would be relevant for sample end users. These patterns were ‘taught’ to REMA. REMA then read all 45K+ PRs within the database looking for the outlined patterns.

Results: The BMs patterns searched for: PDL1, P16, BRAF, KI‐67, MSI. REMA processed over 45K PRs then expressed the data as subsets of between 3K‐14K PRs based on the year of BM release. Results show solid diagrammatical data returns for three of the five patterns (BM results: PDL1 = 88, P16 = 95, KI‐67 = 142). Two patterns returned results (BRAF = 108; MSI = 340) requiring further input to refine more effective REMA pattern definitions.

Conclusion: Using REMA, PDL1 discrete data elements were built for 79 biosamples (out of a 3K subset), P16 for 95 out of 14K, and KI67 142 out of 45K. The discrete data elements were added to the biosample record within the LIMS allowing direct query from the primary LIMS query screen. This saved research staff from having to read, parse, and enter all of these reports manually.

O‐12 The Utility of College of American Pathologists (CAP) Biospecimen Accreditation for Oncology‐Based Research Pathology at Memorial Sloan Kettering Cancer Center: Lessons Learned and the Path Forward

J. Silber, P. J. Sharpe, J. Ray‐Kirton, M. Yang, B. Dobles, U. K. Bhanot, M. H. Roehrl

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Background: The Precision Pathology Biobanking Center (PPBC) at Memorial Sloan Kettering Cancer Center (MSK) is a state‐of‐the‐art, oncology‐focused biorepository engaged in the collection, preservation, and distribution of tumor and healthy tissues for research purposes. The proximity of the PPBC to clinical pathology allows for specimens to be collected at multiple therapeutic time points, accompanied with their associated epidemiologic, clinical, and molecular data. Improving tissue acquisition and processing for downstream applications through research, CAP accreditation is paramount to precision oncology and contributing to early drug development (EDD). The PPBC was recently granted CAP accreditation for its additional research histology laboratory, extending the umbrella of accreditation to include numerous downstream research applications. We wanted to evaluate our path to research CAP accreditation, value added, and insights learned for future development of the PPBC.

Methods: We designed and implemented a detailed quality metrics preparation program over nine months prior to seeking accreditation. A comprehensive quality program capturing multiple quality metrics to accurately gauge laboratory performance is essential to provide committed services that support collaborative research initiatives. Comprehensive digitization of histologic slides (>40,000) created from FFPE blocks to enable real‐time remote histological assessment, surveillance of time lapse from project initiation to completion with defined deviation thresholds, and development of custom web‐based IT database solutions to track specimen chain‐of‐custody are some of the objectives established to strengthen and monitor quality of service.

Results: We successfully developed an effective quality program, improving output while minimizing errors, with the functional capability to monitor quality in real‐time. We expanded our quality program with four quality metrics (10 in total), and we created or updated >25 standard operating procedures. The PPBC biobank and histology laboratories were inspected by the CAP in September of 2021, and after a stringent review, granted CAP accreditation.

Conclusions: CAP accreditation of the research histology operation of the PPBC will help ensure the validity of research data, promoting EDD and precision oncology. Accreditation is a significant investment requiring training of personnel; rigorous equipment care; and institutional vision, support, and leadership.

OPA‐04

Withdrawn

OPF‐02

Withdrawn

OPE‐02 Integrating Biospecimen Science Approaches into Clinical Assay Development: A National Cancer Institute (NCI) Funding Opportunity for Tissue and Liquid Biopsies (PAR‐22‐049)

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

National Cancer Institute, Bethesda, Maryland, United States

Background: The reproducibility of clinical research is critical to the evaluation of biomarkers in clinical assays. Biospecimens are necessary starting materials for biomarker assays, and biospecimen preanalytical factors related to collection, processing, and storage can affect research reproducibility. Variability introduced during biomarker assay development needs to be better understood in order to increase the likelihood of reproducible data to better assist patient diagnosis, treatment, and overall outcome.

Methods: The methods to collect, process, and store small biopsies such as core biopsies and fine needle aspirates, and liquid biopsies such as blood, tissue swabs and secretions, bodily fluids, and more, can vary widely among medical institutions and research laboratories. As a result, variability in preanalytical factors such as biopsy method, biospecimen size/volume, preservation method, and temperature and duration of transport and storage can exist. Preanalytical factors affect the accurate assessment of biomarkers and downstream analysis, highlighting an opportunity to develop standardized practices and fill a critical gap in biospecimen research.

Results: Funded studies will be highlighted to demonstrate how the program is improving understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen preanalytical conditions. Results will provide valuable insights into how to limit variability in clinical assay results from small tissue and liquid biopsies through evidence‐based standardization of biopsy handling procedures and, ultimately, improvement in clinical assay development.

Conclusion: The funding opportunity described supports extramural research to investigate and mitigate challenges facing clinical assay development and analytical validation due to biospecimen preanalytical variability. Responsive proposals examine preanalytical variability related to the procurement and study of small and liquid biopsies, and how various biospecimen preanalytical factors affect emerging and clinically relevant biomarkers quantified by different testing platforms. The program described is a U01 cooperative agreement which includes NCI programmatic involvement with awardees to support and stimulate research in a partnership role. The next receipt dates are June 7th and September 13th, 2022.

Innovative Technology Session

IT‐01 Novel Dry Storage Approach for DNA Preservation at Room Temperature

C. D. Quintas‐Faria^{1, 2}, J. Morgado², A. Hernández², M. Carcajona³, M. Martín Ayuso²

¹DNA National Bank Carlos III, Salamanca, Spain, ²300K Solutions, Salamanca, Spain, ³NIMGenetics, Alcobendas, Madrid, Spain

Statement of the problem: The current gold standard method for long‐term preservation of DNA and any other biospecimen is ultra‐low temperature freezing at ‐80 °C which implies high maintenance and transport costs, large spaces, constant energy supply, and safety measures. Different attempts of dry preservation of biological materials have been made. However, and despite the advantages, there are no standards in the treatment of samples, drying workflow, and storage conditions that allow to obtain and maintain at room temperature (RT) high‐quality samples for long periods of time.

Proposed Solution: 300K Solutions (Salamanca, Spain) offers a proprietary standardized solution for the freeze‐drying and storage of DNA. We evaluated the quality and suitability of the genetic material processed and stored with the proposed method. Multiple aliquots of 6 DNA samples were stored in parallel under three conditions: frozen and stored at ‐80 °C, dried and stored at 22 °C, and dried and stored at 60 °C. Eighteen months at 60 °C storage is equivalent to approximately 21 years at RT. We evaluated the integrity and purity of the DNA samples at different time points during the 18 months of real storage using TapeStation DNA Integrity Number (DIN), Long Multiplex PCR, and spectrophotometric absorbance ratios as standard methods. The 21 years of RT‐equivalent storage did not affect significantly the DNA integrity as assessed by DIN and the detection of the 17,5Kb band in multiplex Long PCR. Moreover, it didn't significantly affect the purity measurements using spectrophotometry (260/280nm and 260/230nm ratios). Whole Exome Sequencing of the RT storage samples showed a recall of 99% in all time points analyzed, when compared with the ‐80 °C gold standard. Finally, we performed a Cytoscan 750K analysis of DNA samples just after its extraction and at the end of the storage period at different conditions, which revealed the same alterations, showing the same loss or gain patterns observed at extraction.

Conclusion: Based on the results obtained, the technology here evaluated demonstrated to be suitable for the long‐term storage of DNA under RT conditions, preserving its integrity and purity and allowing its use with high demanding genomic methods, even after 21 years of RT‐equivalent storage. A standardized methodology like this may enormously contribute to the sustainability of biobanks, removing the dependency on the expensive and risk prone freezing storage of biological specimens.

IT‐02 SARS‐CoV‐2 Sequencing, Polygenic Risk Scores, and Precision Medicine: High‐throughput Solutions

C. Bixby^1, J. McDevitt¹, J. LaPorta, Y. Wang, C. Goswami, J. Schultz, A. Bogdanowicz, S. Smirnov, G. Glinka, H. Blum, K. Rocha, K. Ward, M. Sheldon, R. Hager, R. Grimwood, S. A. Nahas

Sampled, Piscataway, New Jersey, United States

¹Co‐first authors

In the past year, Sampled has excelled in establishing itself in the innovative technologies space by seizing opportunities for exponential expansion. Two examples that will be highlighted are increasing Sampled's Next Generation Sequencing (NGS) weekly throughput 10‐fold over a period of just 30 days and launching itself into the developing field of polygenic risk scores (PRS) with a high‐throughput solution.

In early 2021, the CDC established a SARS‐CoV‐2 variant surveillance program to expand its daily viral sequencing. Sampled was one of six labs contracted due to its capability to obtain positive samples from all 50 US states and to perform NGS of the virus. Sampled was processing up to 60,000 samples daily using their FDA EUA‐ approved qPCR assay (EUA200090). The CDC award presented two obstacles:

Adding staff/equipment to sequence 3,000 samples per week.

Choosing a NGS library prep kit that could meet the turnaround times.

At the time of award Sampled had five Illumina sequencers, four NGS specialists, and one liquid handler with a weekly output of 600 COVIDSeq samples. Over the course of the next 30 days, Sampled evaluated several library prep kits, installed and validated four additional liquid handers, and on‐boarded nine new NGS specialists. By the first week of May 2021 the team was able to expand its capacity to 6,000 samples per week, a 10‐fold increase from 30 days prior.

Polygenic risk score (PRS) testing is an emerging technique to predict the likelihood of a patient developing a polygenic disease. PRS tests utilize multiple variants across the genome that when considered individually have very little impact, but when considered with other variants and clinical information can give an accurate risk of a patient developing the disease of interest. The ability to offer these tests gives physicians valuable information and can positively impact patient care with personalized decision making. Sampled currently offers PRS tests for Alzheimer's and breast cancer. Our high‐throughput and economical methods increase access to these tests and are key to advancing precision medicine.

Several factors contributed to achieving a 10‐fold increase in NGS COVIDSeq weekly capacity over a 30‐day period and developing high‐throughput methods for PRS. These included an Sampled staff who were motivated and flexible to be able to work at a demanding speed and, most importantly, were provided sufficient resources by the Sampled executives to acquire new equipment and staff.

IT‐03 Storage Temperature Monitoring: It Is Not One Size Fits All

M. R. Rusnack

Research and Development, AmericanPharma Technologies Inc, Boise, Idaho, United States

The ISBER Best Practices Fourth Edition publication acknowledges the increasing variety of storage systems for specimen collections. It is also noted that the number, size, and physical nature of the specimens stored should be considered when specifying the storage system for these goods.

Monitoring the storage environment of these specimens is necessary to ensure the quality and long‐term efficacy of these items. When considering a monitoring solution, many factors should be considered:

Storage temperature.

Cryogenic temperatures ‐196 °C.

Ultra‐Cold ‐80 °C.

Freezer ‐45 to ‐20 °C.

Refrigerator 2 to 8 °C.

Incubators 35 °C.

Each temperature range requires a specific sensing technology to ensure the accuracy of the measurement. The precision of each sensing methodology is explored.

Temperature buffer: To prevent alerts that result from regular access to the storage unit (opening the door), temperature buffers are encouraged. The buffer has two purposes:

To prevent false positive alerts due to air temperature excursions.

To simulate the effect of a temperature change on the stored specimen

The size, material, or volume of the buffer is rarely specified. Without an exact understanding of the geometry of the stored materials, the effect of a temperature excursion cannot be measured, only speculated.

With the introduction of Virtual Temperature Buffering™, the contents of the storage unit can be accurately modeled; through the air temperature, the specific consequence of a temperature excursion can be applied individually to each specimen geometry.

System redundancy Given the critical nature of the stored specimens, redundant storage systems are often necessary. Explored are the various options for redundancy. These range from manual recordation systems to cloud‐based solutions utilizing WiFi and cellular communication solutions.

Display and notification portal As important as the monitoring system itself is the human interface. The display system accumulates, stores, and displays the monitor data. This same system that provides the up‐to‐date status of the storage environment provides the notification to the user in the form of alerts when an out‐of‐range reading is detected. Fault notification should include not only the storage environment, but also the health status of the monitoring system

All the above factors are explored in this presentation. Examples already in use are discussed, providing an in‐depth understanding of the technologies available today.

IT‐04 Use Case Perspectives: Connecting the Two‐decade Gap in Biobanking Data Management, from Hardware Core Functionalities to Implementation of Novel IT Solutions in Current Biobanking Operational Systems.

P. Katsaounis, D. Ivanova

Metabio, Thessaloniki, Greece

Statement of the problem: Global biobanking growth demands evolution, leading to collaborations, worldwide biosample dissemination, and associated data, including patients/donors' medical records and related data. Biobanks need working processes to comply with national and international standards, for appropriate infrastructures for collection, processing, and storage, alongside the need for computing and informatics evolution managing large‐scale data. A decade ago, following basic requirements, biobanks developed, creating ad‐hoc operating systems for data storage, processing, and sharing. Big data storage and management requires sets of functions within biobanks' operational workflows and biobank information management systems (BOW and BIMS). In the era of novel technologies, personalized medicine, and target therapy, the main focus of research demands advanced and robust IT infrastructures in order to create global networks for harmonized data processing and sharing. Lack of continuity and interoperability in biobanking leads to significant data loss and diversity. On the other hand, replacement of hardware core operational systems for data storage and paper‐based procedures with advanced solutions for harmonization of data mandates careful planning and infrastructure mapping, to ensure linkage within existing and future biobanking operational procedures.

Proposed Solution: From the viewpoint of an innovative biotechnology company, addressing the gap in biobanking industry, we present a real‐world use case for a biobank's transformation, from use of an assortment of data management solutions to a streamlined unified and standardized system, describing main challenges, barriers, requirements for the adaptability of such novel software systems. Metrics and KPIs were introduced, focusing on main points of improvement in BOW and BIMS. By improving current pitfalls in biobanking operational systems and standard procedures, such systems for harmonization collection and storage of longitudinal data increases the value of:

Biospecimens quality.

Quality of service.

Data exploitation for current and future research needs.

Conclusions: Transformation of operational system improves lab methodology and limits errors and inconsistencies within a biobank's network. Cryopreservation data become manageable for quality control and protocol evaluation; consumables, protocols, lab‐work, and budgeting are intraconnected; differential data acceptance infrastructures per geographical location are harmonized.

IT‐05 Biospecimen Matchmaking: The Data‐Driven Journey from Internal Spreadsheets to Online Inventories to Just‐in‐Time Biobanking

C. Ianelli, J. Mullan, B. Bielak, E. Hubbard

iSpecimen, Lexington, Massachusetts, United States

Problem: Over the past two decades, due in large part to organizations like ISBER, biobanks have popped up around the world. Initially, biobanking was centered on processes for collecting and storing high‐quality specimens, primarily for internal research programs. Little attention was placed on inventory sharing, often leading to low utilization rates and financial strain. Eventually, sustainability became the mantra and online specimen catalogs and marketplaces formed to help make inventories more widely available, bringing biobanks new sources of capital and supply‐chain efficiencies. Now, biobanks are once again at a crossroads. Precision medicine has driven the need for more customized biospecimen collections that often cannot be fulfilled through existing inventories. To adapt, biobanks must think of themselves as not only repositories of specimens, but as conduits for just‐in‐time specimen collections from their inventory of patient populations.

Proposed solution and analysis: iSpecimen will analyze researcher request data, including five years of specimen search data from its iSpecimen Marketplace, to provide insights into how precision medicine is driving the need for “just‐in‐time” biospecimen collections. We will then use this data to propose the requirements of the ideal next‐generation biobanking solution – an online platform that uses biobanking inventory data plus deep healthcare datasets to:

Connect biorepositories to a global network of researchers who need specimens and data.

Enable efficient matchmaking of inventories of specimens and patients across a federated network of providers.

Automate inventory‐based and just‐in‐time biobanking workflows from inquiry‐to‐invoice.

Provide data‐driven insights utilizing AI to help align inventory management and market demand.

Conclusions: The best biobank is an active, empty one. To get there, biorepository managers need solutions that include advanced matchmaking to make existing inventories more accessible along with just‐in‐time biobanking capabilities when prospective collections are needed. Key to creating an effective solution is the coupling of deep healthcare datasets and researcher‐demand data, along with AI and analysis tools, to bring efficiencies to the biospecimen procurement process while helping to drive smarter biobanking inventory strategies.

IT‐06 Introducing an Advanced Sample Management System to a Clinical Biobank for the Collection and Storage of Human Colorectal Cancer Clinical Samples

D. White¹, A. Chawla², A. Wells², J. Nazareth²

¹Bluechiip, Chicago, Illinois, United States, ²Surgical Oncology, Northwestern Medicine, Winfield, Illinois, United States

Statement of the problem: Surgical oncologists routinely perform complex hepatopancreatobiliary and gastrointestinal surgery for cancer patients at Northwestern Medicine Central DuPage Campus and are actively involved in scientific investigation of novel diagnostics biomarkers for gastrointestinal malignancies, namely pancreatic cancer. To facilitate this research, the Northwestern Medicine Surgical Oncology Translational Research Laboratory and Biorepository was established to collect, process, store, and test clinical samples for implementation of innovative biomarkers such as circulating tumor cells and circulating tumor DNA. The value of the samples collected and their susceptibility to degradation outside of cold storage required a system to track not only the sample ID but also ensure quality by capturing sample level temperature throughout the workflow for collection, storage, retrieval, and testing.

Proposed Solution: The Lab partnered with Bluechiip to install their Advanced Sample Management Solution which utilizes mechanical tags embedded in cryovials to provide a unique sample ID and temperature check when scanned. Bluechiip's system is purpose built for cryogenic conditions and provides temperature visibility for samples when they are outside of storage. Bluechiip readers instantly send chain of custody, identity, and temperature to the Stream Sample Manager Software ensuring accurate inventory management whilst reducing sample temperature excursions. The lab will implement Bluechiip to enable tracking and management of the clinical samples, whilst seeking to improve productivity and ensure sample integrity.

Conclusions: By utilizing Bluechiip's unique technology, the lab ensured samples are frozen after collection within the appropriate time. Bluechiip readers enable bulk data entry and instant storage location allocation of new samples within a cryobox before being stored in ‐80 °C freezers. When samples are removed for testing, an electronic picklist is sent directly to the readers, eliminating paper, and guiding the lab to correct sample locations. Sample retrieval time was minimized and samples were identified without manual frost removal. After retrieval, DNA was extracted from samples and diagnostic assays such as next generation sequencing and digital droplet polymerase chain reaction experiments were performed. The Bluechiip system, which is CFR21 Part 11 compliant, ensured the quality of the preserved samples was not compromised.

Poster Session

Biobank Tools

PA‐01 Participation in Proficiency Testing Program is Associated with Improvement of Biobank Laboratory Performance

O. Kofanova¹, P. Verderio², C. Ciniselli², A. Gaignaux¹, S. Saracino¹, F. Betsou³

¹Integrated Biobank of Luxembourg (IBBL), Luxembourg Institute of Health, Dudelange, Luxembourg, ²Unit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Italy, ³Laboratoire National de Santé, Dudelange, Luxembourg

Background: In a biobank laboratory, processing methods are defined as procedures, applied to biological material during collection/preparation/storage, with potential to impact the intrinsic properties of the biological material produced as output of the procedure [ISO 21899:2020]. High performance of specimen processing methods is a crucial factor in multi‐site clinical trials. The use of improper procedures leads to production of biospecimens of questionable quality. External quality assurance (EQA) assessment of the performance of a processing method is traditionally embedded into the EQA or proficiency testing (PT) schemes targeting associated downstream diagnostic assays of interest. Furthermore, recently EQA assessment of the processing methods has become a requirement for biobank accreditation.

An annual PT program has been introduced for biobanks by the IBBL 10 years ago with the aim to provide an independent assessment of the performance of biobank laboratories. The objective of this study was to perform a global historical analysis in the context of SPIDIA4P project on almost 1,000 EQA schemes in order to assess the impact of critical preanalytical factors on quantitative or qualitative attributes of different types of specimens and laboratory performance patterns over time.

Methods: Statistical analysis was performed within each EQA scheme based on standard categorized preanalytical data provided by participants and on centralized measurements of relevant quality attributes of the produced specimens (z‐scores): DNA, cfDNA, or RNA extraction from blood; DNA or RNA extraction from formalin‐fixed tissue; DNA or RNA extraction from frozen tissue; DNA extraction from saliva or stool; and viable PBMC isolation and cryopreservation.

Results: The most critical preanalytical factors in nucleic acid extraction schemes were the nucleic acid extraction method and kit, the elution buffer, the enzymes used during extraction, the input material quantity, and the storage temperature. Objective indications of laboratory performance improvement over time could be seen in several schemes.

Conclusions: EQA for processing methods provides unique evidence‐based insights into the impact of preanalytical factors, and the comparative performance of different processing methods and kits. EQA reports, including qualitative or quantitative attributes of the produced biological material, can be used as input for validation of a processing method by individual biobank laboratories.

PA‐02 Social Implementation of BiTA, A Qualifying Examination to Evaluate the Competence of Biorepository Personnel

J. Ikeda¹, H. Nakae¹, K. Hattori², K. Matsushita³, Y. Miyagi^{4, 5}, M. Morita^{6, 7}, S. Ogishima⁸, T. Takeuchi⁹, T. Tsuruyama¹⁰, T. Morisaki^{11, 12}

¹Research & Development, Council for Industrial use of Biological and Environmental Repositories, Chiyoda‐ku, Tokyo, Japan, ²Department of Bioresources, Medical Genome Center, National Center of Neurology and Psychiatry, Tokyo, Kodaira, Japan, ³Department of Laboratory Medicine & Division of Clinical Genetics and Proteomics/ Center for Cancer Genomes/Center for Ultrasound, Chiba University Hospital, Chiba, Japan, ⁴Research Institute, Kanagawa Cancer Center, Yokohama, Japan, ⁵Biospecimen Center, Kanagawa Cancer Center, Yokohama, Japan, ⁶Okayama University Hospital Biobank, Okayama University Hospital, Okayama, Japan, ⁷Graduate School of Interdisciplinary Science and Engineering in Health Systems, Okayama University, Okayama, Japan, ⁸Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan, ⁹Tsukuba Human Tissue Biobank Center, University of Tsukuba Hospital, Tsukuba, Japan, ¹⁰Kyoto University, Kyoto, Japan, ¹¹IMSUT Hospital, Department of Internal Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan, ¹²BioBank Japan, Tokyo, Japan

Background: In the biomedical field, reproducibility has always been an issue. Biobanking is a core activity of the research infrastructure that solves this problem and improves the reliability of data in publications and in the outcome of research. By generating data using biological samples and associated data whose quality is guaranteed based on international standards, it is possible to reduce the variability caused by these factors, which is expected to contribute to the improvement of reproducibility in the biomedical field.

Methods: The international standard ISO 20387 is an international consensus‐based document that specifies biobanking activities. In addition to the handling of biospecimens and associated data, it also specifies requirements for personnel involved in biobanking. For example, 6.2.2.5 states that “Personnel shall receive appropriate and relevant assessment at regular intervals to determine what is required to acquire and retain their necessary competence,” which requires regular and continuous assessment of personnel competence. In addition, accreditation programs for biobanks based on ISO 20387 are being prepared in various countries, and also in Japan a program to certify the requirements of this standard by a third party will soon be in operation.

Results: Considering the use of such a program to evaluate competency, CIBER has started a qualifying examination for biorepository personnel called Biorepository Technical Administrator (BiTA) in FY2020. This year marks the second year of the qualification, and awareness of the program is gradually spreading. Initially, this qualifying examination was intended for personnel within the biobank, but since the personnel who conduct technical reviews for the implementation of the ISO 20387 accreditation program also need to be assessed for competence, the examination is now being applied to assess the competence of reviewers as well.

Conclusion: CIBER intends to contribute to the social implementation of BiTA as a reliable tool for assessing the competence of personnel in the context of such social trends.

PA‐04 Updates to the Ethical, Legal, and Policy Best Practices of the NCI Best Practices for Biospecimen Resources

C. Weil³, H. Ellis¹, L. Campbell², A. Rao³, H. Moore³

¹Biobanking Without Borders, LLC, Durham, North Carolina, United States, ²Independent Biobanking Consultant, Deluth, Georgia, United States, ³National Cancer Institute, Bethesda, Maryland, United States

Statement of the problem: The Biorepositories and Biospecimen Research Branch (BBRB) of the National Cancer Institute (NCI) first published the Best Practices for Biospecimen Resources in 2007, with later revisions published in 2011 and in 2016. The previous revisions included new sections on biospecimen resource management and operations, conflicts of interest, and expansion of sections related to custodianship, informed consent, return of results, and community engagement. In 2021, updates were initiated to address changes in the Common Rule, a continued need for diverse participation in research, and increased emphasis on trust and community engagement in research.

Proposed Solution: BBRB reorganized the Ethical and Legal Policy Best Practices (ELP‐BP) section, renaming it “Governance and Custodianship Best Practices.” This new approach acknowledges and emphasizes that custodianship and governance are the fundamental principles forming the framework from which all ethical, legal and social implications best practices originate. Indeed, all aspects of biobanking best practices are guided by the policies biobanks put forth within their governance plans, derived from the responsibilities of the biobank custodian regarding the samples and data that are collected, maintained, protected, and distributed for research. The updates further reflect developments in citizen science, increased consensus about the importance of returning aggregate research results and individual results to participants and their providers, and digital technologies which can enhance the informed consent process and participant involvement in research. Other updates include a discussion of the regulatory changes of the 2018 Common Rule “Final Rule” and expansion of the Legacy Best Practices section in recognition of its critical role in biobanking governance.

Conclusions: NCI has updated and reorganized the NCI Best Practices for Biospecimen Resources to reflect regulatory changes, evolving principles of governance and custodianship, and consensus regarding the importance of both increasing diverse participation in research and engaging participants as partners in the planning and conduct of biobanking.

PA‐05 The Mathison Centre Neurogenetics Biobank and Advancing in Precision Mental Health

S. Shaheen

Medical Genetics, 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 child and youth mental health.

Methods: Our biobank system features state‐of‐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:

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.

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

Research involvement with biobank:

Genetic and environmental influences on behavior and cognition in childhood meuropsychiatric disorders.

PGx ‐Spark: the discovery of pharmacogenetics markers and tools for child and youth mental health. The aim of this project is to implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.

Harnessing the power of population‐based samples for detecting Gene x environment interactions.

Brain function and genetics in pediatric obsessive‐compulsive behaviors. Funding NIH, CIHR.

Results: To date, our biobank has successfully stored 2,167 out of 4,064 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.

Conclusion: The Mathison 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.

PA‐06 Listening to the Voice of the User to Inform the Next Edition of ISBER's Best Practices: Recommendation for Repositories

E. Snapes^{2, 1}, M. Bledsoe³, C. M. Allocca⁶, C. D. Arant⁷, M. De Wilde⁴, S. O'Donoghue⁵, P. Watson⁵, D. Simeon‐Dubach⁸

¹BioConsulting, Cork, Co. Cork, Ireland, ²Editor‐in‐Chief, ISBER Best Practices, 5th Edition, Vancouver, British Columbia, Canada, ³Biopreservation and Biobanking, Independent Consultant and Deputy Editor, Colorado Springs, Colorado, United States, ⁴Iridium Network, GZA Ziekenhuizen, Antwerp, Belgium, ⁵BC Cancer Agency, Vancouver, British Columbia, Canada, ⁶Standards Coordination Office, National Institute of Standards and Technology, Gaithersburg, Maryland, United States, ⁷Life Sciences, A2LA, Frederick, Maryland, United States, ⁸medservice, Biobanking Consulting & Services, Walchwil, Switzerland

The ISBER Best Practices: Recommendations for Repositories, Fourth Edition is an internationally‐well regarded comprehensive tool for use by the biobanking community to help in establishment, management, and operation of a repository. The first edition was published in 2005 and the document has undergone a number of iterations since then. Topics covered within the document have increased in number and depth over the years and provide a foundation upon which the fifth edition will be developed during 2022.

This juncture represents an opportunity to elicit the opinions, ideas, and feedback based on the experience of all users of the Best Practices document, both ISBER members and non‐members. Many repository professionals, among others, are intrinsically motivated by services they can render for the good of all. It reflects well on us all to facilitate this where possible. For the first time in the ISBER Best Practices developmental history, ISBER reached out to global users to invite commentary on any and all parts of the document, including those related to its format and structure. An ISBER Gap Analysis Task Force has used a variety of methods including a survey, focus groups, and roundtable discussion to engage with the document users. The primary goal was to hear and listen to the voice of the user, and though this to identify gaps or deficiencies within the existing fourth edition document, and new practices that have emerged over recent years.

Aggregated results of the Gap Analysis Task Force activities will be presented to illustrate the value of engaging with the extended biobanking community to advance the next edition of the ISBER Best Practices document and thereby our collective knowledge.

PA‐07 Development of the Next Edition of ISBER Best Practices for Repositories

E. Snapes^{2, 1}, D. Simeon‐Dubach³, J. Carpenter⁵, T. Tarling⁴, A. Torres⁶

¹BioConsulting, Cork, Ireland, ²Editor‐in‐Chief, ISBER Best Practices, 5th Edition, bestpractices@isber.org, Vancouver, British Columbia, Canada, ³medservice, Biobanking Consulting & Services, Walchwil, Switzerland, ⁴Provincial Health Services Authority, BC Cancer, Vancouver, British Columbia, Canada, ⁵Biobanking Services, NSW Health Pathology, Newcastle, New South Wales, Australia, ⁶International Society for Biological and Environmental Repositories, Vancouver, British Columbia, Canada

Biobanking is constantly evolving. For a best practices compendium to remain relevant, the content must be revised regularly. ISBER Best Practices: Recommendations for Repositories, Fourth Edition is currently undergoing a review and development process in order to inform the next fifth edition.

The ongoing development phase of ISBER's Best Practices for Repositories is project‐managed by an Editorial Board comprising an Editor‐in‐Chief working in conjunction with volunteer associate editors, content developers, and reviewers. A Steering Committee acts as an advisory to the Editor‐in‐Chief and reports to ISBER's Board of Directors.

The Editorial Board establishes criteria to assess candidate practices in order to determine suitability of a practice to be included in the document. Where possible, this includes the extent to which that practice is informed or rooted in previous research or experience. While longevity of establishment can attest to the level of maturity of a practice, consideration will also be given to crisis‐induced practices that have emerged over recent years and additionally have potential to be retained as best practices going forward.

While some peer‐reviewed evidence supporting new practices was gathered within the review phase, further efforts to identify scientific evidence relevant to new content is necessary. This can include complementary evidence from observations with other sources or methods. It is essential to evaluate such evidence to inform decisions for inclusion of a candidate practice within the fifth edition, or to hold back for further maturation and perhaps inclusion in subsequent editions.

The development project continues the good work done on establishing the compendium to date. It facilitates best practice sharing to further benefit repositories. Insights into the criteria for evaluation of candidates practices will be shared along with some of the challenges of incorporating user feedback.

By adopting methods of feedback, reflections, and analysis of the fourth edition, it is hoped that the extended biobanking community beyond those involved in the editorial team become effective co‐contributors.

PA‐08 Mapping A Sunburnt Country: An Australian National Biospecimen Locator

C. Griffin¹, A. Hettiaratchi², G. Reaiche‐Miller³, P. Saunders⁴, J. Koch⁵, L. Devereux^{6, 7}

¹NSW Regional Biospecimen Services, University of Newcastle, New Lambton, New South Wales, Australia, ²UNSW Biospecimen Services, University of New South Wales, Sydney, New South Wales, Australia, ³Adelaide Biobank, The University of Adelaide, Adelaide, South Australia, Australia, ⁴Pamela Saunders Consulting, Adelaide, South Australia, Australia, ⁵Justin Computers, Melbourne, Victoria, Australia, ⁶Cancer Genetics Laboratory, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia, ⁷Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia

Statement of the problem: The Australian biobanking landscape has grown rapidly in response to the increasing demand for high‐quality biospecimens. While inherently positive, rapid national growth has contributed to inconsistencies in practice and a fragmentation of the biobanking community resulting in redundant resource expenditure, inefficient use of existing collections, and limitations on collaboration for biobankers and researchers alike. This is particularly problematic in disciplines where sample rarity and scarcity are enduring challenges and where collaborative working is essential to achieve critical mass or a multi‐disciplinary focus. Likewise, with the increasing emphasis on “One Health” approaches to research, the integration of agricultural, zoological, microbial, environmental, and human biological collections is imperative. To achieve this, visibility of existing collections is paramount.

Proposed Solution: The Australasian Biospecimen Network Association (ABNA), following on from the foundational work of ABN‐Oncology, is launching an expanded iteration of the TSL/National Specimen Locator. Inspired by existing infrastructure, such as that of BBMRI‐ERIC, the Biospecimen Locator will be multi‐disciplinary and provide a central source of information for sample custodians as well as academic and industrial researchers. Increasing usability and maximizing research utility of catalogued samples, the platform will also include research services embedded within biobanking infrastructure such as sample processing, collection protocol development, and clinical trial support.

Extensive stakeholder engagement through the ABNA network is currently underway with the first upload of sample data intended for April 2022. A core focus is the recognition and inclusion of new collections from emerging research priorities and the integration of cross‐disciplinary collections to maintain an emphasis on representation and diversity. Following a pilot phase there is scope for expansion through ABNA's Australasian network and for integration with international colleagues and aligned platforms.

Conclusion: A concerted approach to promoting harmonization and maximizing biospecimen research utility can only be achieved through increased visibility and networking on a national scale. The National Biospecimen Locator will fulfill this unmet need while fostering collaboration between biobankers, academic research teams and industry partners – providing return on investment for all.

PA‐09 Teaching Tissue Microarray Technology and its Applications as a Quality Control Tool in Research and Diagnostics

A. Khramtsov¹, A. Rodriguez², J. Bellis¹, J. Holcomb¹, D. Kersey^{1, 2}, J. Taylor², G. Taborn², C. Lucas², N. Arva¹, G. F. Khramtsova^{1, 2}

¹Department of Pathology and Laboratory Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, ²Stanley Manne Children's Research Institute affiliated with Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

Background: Biobanks will collect and store samples associated with data and information that will contribute to more precise research, personalized treatment, and more efficient health care systems. Thus, the education and professional development of a new generation of biobank professionals are essential. The work presented here aims to compile an educational course to cover several biobank operational activities and associated technologies: from acquiring, collecting, storing, and sharing biological samples for tissue microarray (TMA) construction and imaging slides to collecting associated meta‐data. As part of this training, we propose to use TMA technology as a quality assurance and quality control tool for biorepository.

Methods: For this course, we created a pilot project, “LEARN to SWIM,” and generated a TMA from small round blue cell tumors: L‐Lymphoma, E‐Ewing Sarcoma, AR‐Alveolar Rhabdomyosarcoma, N‐Neuroblastoma, S‐Synovial Sarcoma, W‐Wilms Tumor, I – INI‐1 Loss‐Rhabdoid Tumor, M‐ MISC‐Malignant Peripheral Nerve Sheath Tumor; Hepatoblastoma; Desmoplastic Small Round Cell Tumor; Alveolar Soft Part Sarcoma; BCOR‐Clear Cell Sarcoma. To achieve the goals for this project we reviewed the appropriate College of American Pathologists requirements for TMAs; reviewed modern literature regarding TMA design, construction, and validation; developed and designed a procedure for TMA construction; collected slides and blocks from a biorepository archive; constructed a TMA; performed validation of H&E and IHC (using β‐Catenin, Myogenin, CD99, PAX8, PHOX 2B biomarkers)‐stained TMA slides; and, finally, prepared digitalized TMA images using a digital slide scanner for further validation.

Results: We developed and implemented a training course for biobank staff, researchers, and students. The course consists of several modules covering material on specimen handling, sample/data inventory safety management, and quality control, as well as TMA design, construction, cutting, staining, imaging, and analysis. The first course took place in 2021‐2022 and will be offered every year.

Conclusion: Implementation of this course allows participants to learn the theoretical background and obtain practical skills to use TMA technology, whole slide imaging, and machine learning technology in any research project. This course provides an example of creative and innovative training material for the new generation of medical and research professionals utilizing biobank resources.

PA‐10 Quality Assurance/Quality Control (QA/QC) Activities of the NIST Biorepository

R. S. Pugh, D. L. Ellisor, J. C. Hoguet, A. J. Moors, J. M. Ness, S. Schuur

Chemical Sciences Division, NIST, Charleston, South Carolina, United States

A biorepository is established to provide high‐quality biological and environmental specimens and its associated data for scientific research. To ensure these specimens are of the highest quality, standard operating procedures must be developed and adhered to for specimen collection, processing, storage, retrieval, and distribution. If deviations occur from these procedures, how does that impact the specimen? Is the specimen still valuable for its intended purpose or suitable for other downstream analyses? How are these deviations documented? The establishment, documentation, and implementation of a quality management system (QMS), which includes quality assurance and quality control (QA/QC) activities, are integral to each step of the biorepository and will lead to and ensure a successful long‐term program. The National Institute of Standards and Technology (NIST) is the National Metrology Institute of the United States of America and has an established QMS that comprises policies and procedures which NIST follows in pursuit of performance excellence. The Biospecimen Science Group of the Chemical Sciences Division (CSD) manages the day‐to‐day operations of the NIST Biorepository and has maintained a quality manual that includes QA/QC activities such as technical documents, organizational charts, data tools, standard operating procedures, etc., which supports a commitment to providing excellence in specimen banking. These activities that ensure a high‐quality specimen is archived at the NIST Biorepository and available to the scientific community will be presented.

PO‐04 Implementation Model of Quality Control Procedures of Fresh Frozen and FFPE Tissue Samples Along with Proficiency Testing Program for Biobanks

A. Michalska‐Falkowska, J. Niklinski

Department of Clinical Molecular Biology, Medical University of Bialystok, Bialystok, Poland

Statement of the problem: A properly functioning Quality Management System (QMS) within a biobank represents a fundamental structure for maintaining the high quality of all activities carried out in the process of biobanking. The role of active QMS is indispensable, since the collected samples are used in research focused on better understanding of diseases, development of novel diagnostics methods, and personalized therapy. Standardized methods of collection, transportation, preparation, and preservation have direct impact on sample quality and are important for reproducibility of studies and minimizing the incidence of false results due to low‐quality biospecimens.

Proposed Solution: To develop the awareness of tissue quality among biobanks and to present ready‐to‐implement quality control procedures, model dedicated to fresh frozen and FFPE tissue samples was proposed. This model arises from the need to create standardized collections with strictly defined quality criteria for use in high‐throughput research. Therefore, there is demand for multifactorial development of quality control procedures, taking into account the broadest range of variables influencing the properties of the tissue. The model was divided into four stages, according to the chronology of individual processes:

Development of methods and quality control procedures for solid tissue: preparation of standard operating procedures and forms specifying the acceptance criteria according to the most recent literature data and international guidelines. Quality control methods include macroscopic evaluation of tissue samples, microscopic evaluation of slides, DNA and RNA concentration, purity, and Integrity Numbers.

Validation of methods and quality control procedures for solid tissue to determine the suitability of individual parameters, the efficiency of given methods, and their limitations.

Development of guidelines and quality control standards for solid tissue.

Offer of Proficiency Tests for solid tissue in the range of selected parameters.

Conclusions: Tissues are made up of very complex structures consisting of heterogeneous cells populations that differ in the expression of individual genes, which shape their functions. The development and validation of quality control methods will allow the determination of key parameters and verification of assumed acceptance criteria. On the basis of the obtained results, guidelines and standards for methods of quality control of solid tissue will be developed.

Biobanking profiles

PB‐01 Study of Laboratory Staff Knowledge of Biobanking in Côte d'Ivoire

A. K. Kintossou^{1, 2}

¹Biobank, Pasteur Institute of Côte d'Ivoire, Abidjan, Côte d'Ivoire, ²Training and Research Unit of Biosciences, Felix Houphouët Boigny University, Abidjan, Côte d'Ivoire

Background: Biobanks are entities that manage and make available biological resources. Biobanks have medical, scientific, and economic interests and work in an ethical manner. Since 2009, Côte d'Ivoire has had a biobank, which now houses the ECOWAS regional biobank. To ensure optimal and efficient use of this biobank, scientific stakeholders must be aware of its existence and role. It was therefore necessary to assess the knowledge of laboratory staff about the activities of a biobank.

Methods: This descriptive study was done by questioning staff from laboratories working on human health, animals, or plants. The laboratories were located in southern Côte d'Ivoire.

Results: A total of 205 people completed the questionnaire. Of these 205 people, 34.63% were biologists, 7.32% engineers, 48.78% technicians, and 9.27% PhD students. The average length of work experience was 10.11 ± 7.83 years. In this study, 43.41% of the participants had never heard of biobanking. Only 48.78% of participants had a good understanding of the role of a biobank. Technicians and PhD students were less educated on the notion of biobanks (p < 0.000001). Although biologists were more educated on this issue, 21.13% of them had a misconception of biobanks. Good knowledge of the role of a biobank was not significantly related to the work experience's length (p > 0.88).

Conclusion: Therefore, training on the role and interests of the biobank is important.

PB‐02 Building a Cancer Biobank in a Low‐Resource Setting in Northern Iran: the Golestan Cancer Biobank

F. Ghasemi‐Kebria⁵, N. Jafari‐Delouei⁵, T. Amiriani⁵, A. Norouzi⁵, B. Abedi‐Ardekani⁶, D. Nasrollahzadeh^{6, 2}, M. Ashaari⁵, S. Besharat⁵, M. Naeimi‐Tabiei⁵, I. Gharanjic⁵, Z. Babapalangi⁵, H. Poustchi², S. Semnani^{7, 5}, A. Fazel³, Z. Kozlakidis¹, E. Weiderpass⁴, G. Roshandel⁵

¹Laboratory Service and Biobank Group, International Agency for Research on Cancer, World Health Organization (WHO), Lyon, France, ²Digestive Oncology Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of), ³Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran (the Islamic Republic of), ⁴Office of the Director, International Agency for Research on Cancer (IARC), World Health Organization (WHO), Lyon, France, ⁵Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran (the Islamic Republic of), ⁶International Agency for Research on Cancer (IARC), World Health Organization (WHO), Lyon, France, ⁷Omid Cancer Research Center, Golestan University of Medical Sciences, Gorgan, Iran (the Islamic Republic of)

Background: We aim to present the development and the initial results of the Golestan Cancer Biobank (GoCB), in a low‐ resource setting in northern Iran.

Methods: The GoCB protocol and its standard operation procedures were developed according to internationally accepted standards and protocols with some modifications considering the limited resources in our setting. The main biological samples collected by the GoCB include blood sample, urine sample, fresh endoscopy tissue sample, fresh surgical tissue sample, and formalin‐fixed paraffin‐embedded tissue sample. The GoCB collects patients' demographic data, tumor characteristics, as well as data on risk factors. We developed a specific GoCB software for management of patient data and biological sample information. The GoCB dataset is annually linked with the Golestan cancer registry dataset to add complementary data (e.g., survival data).

Results: The GoCB started collection of data and biological samples in December 2016. By November 2020, a total number of 1,217 cancer patients participated in the GoCB. The majority of the GoCB participants (n = 942, 77%) were those with gastrointestinal and breast cancers. Data on risk factors were successfully collected in 684 (56.2%) of the participants. Overall, 3563 samples were collected from the GoCB participants and 730 samples were used in 7 national and international research projects.

Conclusion: We considered specific strategies to overcome major limitations, especially budget shortage, in the development and maintenance of a cancer‐specific biological repositories in our setting. The GoCB may be considered as a model for the development of biobank in low‐ and middle‐income countries.

Keywords: Biobank, Cancer, Iran, Low‐ and middle‐income countries

PB‐03 UMMC Biobank: Biobanking For Collaborative Research

G. J. Mahajan, V. N. Seerapu, T. Rajguru, S. Faruque, J. Rankin, R. Summers

Biobank, University of Mississippi Medical Center, Jackson, Mississippi, United States

Background: The University of Mississippi Medical Center (UMMC) Biobank is a biorepository facility that is created to provide high‐quality specimens with precise and reliable information to investigators to use in translational research and clinical consideration. Since its inception, the biobank has been serving as a biospecimen repository for head and neck, colorectal, obstetric, and gynecologic cancer; obesity; and ventricular assist device procedures. UMMC Biobank works in partnership with Mississippi Organ Recovery Agency to process and store unutilized donated organs. An adult and pediatric COVID 19 biobank was initiated when the pandemic started. Stem cell culture and banking is an upcoming collection for the UMMC biobank.

Methods: The Biobank has dedicated biorepository specialists charged with obtaining institutional review board‐approved informed consents, specimen handling, and processing. Physicians in surgical pathology aid with fresh tissue sample procurement. The current facilities are designed for processing and storage of specimens, including two centrifuges (refrigerated and ambient temperature), two biological safety cabinets, automated liquid handler, two liquid nitrogen storage tanks, and eight temperature‐controlled ‐80 °C freezers with monitoring system. UMMC Biobank participants are registered in the database along with demographic and histology variables. Samples collected include whole blood, serum, plasma, buffy coat, tumor and normal tissue, nasopharyngeal swabs, urine, and PBMCs. They are handled according to the International Society for Biological and Environmental Repositories (ISBER) best practices. The informed consent allows access to historical and future clinical data from electronic medical records (Epic), ensuring donor anonymity and regulatory safeguards. The institutional biospecimen access committee reviews all specimen requests.

Results: There are nearly 20,000+ biospecimens preserved at UMMC Biobank. De‐identified specimens are provided to UMMC and industry researchers. UMMC Biobank has successfully provided support to over 50 clinical trials and research projects through expertise developed by biobank staff. This is an ongoing collection and we aim to be the largest biobank in the state of Mississippi in coming years

Conclusions: UMMC Biobank is a growing facility for qualified biomedical researchers to enable translation of precision medicine initiatives into communities with health disparities

PB‐04 Singapore Translational Cancer Consortium

K. A. Wong, F. Gan, F. Lew, J. Tan, L. Xu, C. Chow, C. Eng

National University Health Systems (NUHS), Singapore, Singapore, Singapore

Statement of the problem: Singapore's approach to healthcare is herald as a world‐class healthcare system. The Singapore Translational Cancer Consortium (STCC) was established in 2020 to better coordinate systemic research amongst multiple health and academic institutions for better cancer research and care.

Proposed Solution: The STCC was established in 2020 as a nationally coordinated initiative and network to synergize cancer research and translational capabilities across Singapore. It aims to bring together Singapore's best basic, clinical, and translational talent in Singapore and advance global research and translational competitiveness to the next level by establishing and implementing collaborative cancer research programs originating from the local cancer research community as well as partnerships from the industry. The consortium will integrate our partners in hospitals and research institutions to create a one‐stop concept to coordinate and provide the cancer community and industry with an enabling research and innovative environment. STCC represents a major opportunity for Singapore to be recognized as a global leader for selected Asian cancers in terms of research and translational capabilities, through building peaks of excellence and thought‐leadership, and demonstrating healthcare and/or economic value creation through its synergistic platforms and programs. STCC focuses on research that demonstrate potential for high‐impact value‐based applications in health and healthcare, specifically in cancer prevention, screening, treatment, and patient care in Singapore.

Conclusion: The consortium is currently in Phase 1 implementation, focusing on the operationalization of the four joint platforms through selected projects as use cases: clinical trials and investigational medicine unit, cancer databases and tissue banks, research‐based molecular diagnostics platform, and business intelligence and development unit.

PB‐05 The Neurodegenerative Disease Biobank at Macquarie University, Sydney, Australia

S. D'SIlva^{1, 2}, E. Cachia¹, O. Ishola¹, J. Atkin¹, R. Chung¹, G. Guillemin¹, K. Ratinac¹, D. Rowe^{1, 2}, K. Williams¹, I. Blair¹, S. Furlong¹

¹Biomedical Sciences, Macquarie University, Macquarie University, New South Wales, Australia, ²MQ Health Neurology, Macquarie University, Macquarie University, New South Wales, Australia

Motor Neuron disease (MND) is a fatal neurodegenerative disease characterized by progressive loss of motor neurons, which control muscle movement and function. From symptom onset, patients typically die within two to five years and every year in Australia around 800 people are diagnosed with this disease. Currently, there is no therapy to reverse the effects of the disease or to prevent its progression.

In 2013, Macquarie University's Centre for MND research and Macquarie Neurology clinic joined forces to establish the Neurodegenerative Disease Biobank. MND patients and controls are invited to participate in the biobank, by donating blood, urine, hair, and skin biopsies. Extensive clinical data are collected from each participant. Participants are also invited to complete an online environmental and lifestyle questionnaire.

This resource has grown rapidly with more than 900 participants, 2650 collections, and over 50,000 sample aliquots. As one of the largest MND biobanks in the world, with a collection of well‐characterized samples and extensive clinical and lifestyle data, it is an extremely valuable resource to investigate MND pathogenesis and treatment strategies. The biobank attained NSW Health biobank certification in 2019.

Access to biobank resources is obtained via a biobank access committee and a cost‐recovery fee applies. Since 2013, 28 research projects have availed of this resource, most of which are large complex projects involving multiple national and international collaborators.

The biobank is presently collaborating on a clinical trial being conducted within the University. There is also work underway to improve data quality by means of data curation.

This biobank is an excellent example of a medium‐sized biobank with a collection of high‐quality samples, interdigitated with extensive clinical records that can support numerous complex research projects to make major advances in the understanding of a complex disease.

PB‐06 ARICE: Twinning for the Armenian Research Infrastructure on Cancer Research

K. Sargsyan^{1, 2}, G. Hartl¹, T. Sarkisyan², D. Babikyan², J. Kinkorova³, B. Jaksa¹, C. Mitchell¹, Z. Kozlakidis⁴

¹International Biobanking and Education, Medical University of Graz, Graz, STMK, Austria, ²Department of Medical Genetics, Yerevan State Medical University, Yerevan, Armenia, ³Faculty of Medicine, Unicersita Karlova, Praha, Czechia, ⁴Laboratory Services and Biobanking, IARC: CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER, Lyon, France

Twinning for the Armenian Research Infrastructure on Cancer Research (ARICE) aims to increase the research infrastructure capacities in the field of cancer research in Armenia, through integrating a robust pathology background with state‐of‐the‐art biobanking to a research‐ready data structure. This will be achieved by establishing close cooperation with the leading expert‐institutions in the field (Medical University Graz, Charles University, and IARC) as well as by facilitating the spread of the competencies at institutional, national, and regional levels. Cancer research infrastructure has been chosen as the focus because Armenia has a very high incidence and mortality of cancers, as well as a very high prevalence (according to incidence) among rare malignant diseases, while it underperforms in cancer research when compared to the EU average. ARICE will ensure cancer research infrastructure gets appropriate attention in order to support further local research in Armenia and in the wider Caucasus region, including former Soviet Republics. New scientific developments in the field of cancer prevention, in particular in biomarker research and large population‐based investigations, are in place to facilitate success in research in this field. The ARICE project is going to be an important step for reaching the set goals both efficiently and effectively. The competencies acquired in this field during the project realization will be easily transferable to other fields of research related to medicine, biology, medical ethics, health economics, and biostatistics. The involvement of researchers from multiple specialties (physicians of different specialties, biologists, data management specialists) hosted by the Yerevan State Medical University will ensure this smooth transfer of expertise.

PB‐07 The NIGMS Human Genetic Cell Repository: A Biomedical Research Resource

S. Sander‐Effron, M. Mitchell, N. Turan

Coriell Institute for Medical Research, Philadelphia, Pennsylvania, United States

Statement of the problem: Reproducible and rigorous biomedical research is critical for the understanding of basic biology underlying human disease. Key to investigations into this field of study is the availability of high‐quality biospecimens with which to conduct research. The use of improperly collected and/or controlled biospecimens that lack sufficient benchmark validations puts at risk the integrity of research studies, generating poor results that are of little use to the scientific community and compromise progress.

Sample type diversity is important to produce research results that are generalizable to the larger human population rather than being of limited applicability to a particular subset of the population. This includes sample donor diversity (i.e., ancestry) as well as inter‐ and intra‐disease diversity (e.g., multiple disease subtypes, multiple mutation types underlying a disorder). When investigators source research materials on their own, they are often subjected to the limitations of their own personal and professional network.

Proposed Solution: The NIGMS Human Genetic Cell Repository (HGCR) is a resource that consolidates efforts toward a standard framework for the production of diverse, properly consented, high‐quality biospecimens for biomedical research use. The utilization of this centralized resource that is focused on the generation, maintenance, and distribution of these samples allows researchers to focus on the application of novel techniques and further research downstream. Researchers can rely on the quality of samples collected appropriately and screened thoroughly to conform to benchmark standards, such as cell line authentication via identity, sterility, viability, and genomic stability testing. The NIGMS HGCR continuously devotes efforts to enhance the available materials, by introducing more rigorous QC metrics, additional characterization, and expanding the available selection of products.

Conclusions: Meta‐analysis of research utilizing samples from the NIGMS HGCR shows consistent output of research manuscripts in top‐tier journals, covering a wide range of topics that span many disorders. The legacy impact remains important, as the re‐use of samples by multiple investigators over time further deepens the studies' impacts, which build knowledge upon each other. To this end, efforts to re‐characterize biospecimens have been dramatically reduced, allowing researchers to expand their focus to broad scientific questions.

PB‐08 The Management of Oral and Maxillofacial Cancer Biobank and Its Access

X. Pan^{1, 2}, Q. Xu^{1, 2}, Z. Li^{1, 2}, Z. Zhang^{1, 2}, M. Yan^{1, 2}, W. Chen^{1, 2}

¹Department of Oral and Maxillofacial‐Head & Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology and National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology, Shanghai, China, ²Sharing platform for the tissue sample and bioinformatics database of oral maxillofacial tumor, Shanghai, Shanghai, China

Strict‐managed and well‐maintained tumor biobank are amongst the most important resources for translational and precision medicine. According to the experiences from international large‐scale biobanks construction, the operation and quality management system of Oral and Maxillofacial Cancer (OMC) tissue bank in Shanghai, China has been established following the standardization ideas of the International Organization for Standardization and World Health Organization. The OMC tissue bank operates under well‐defined and standardized procedures and more than 30 standard operating procedures, including sample collection, management, sharing, and clinical translational studies. OMC tissue bank owns sufficient and diversity biological samples resources; the scale of operations is amongst a leading one globally, storing at least 119,400 high‐quality samples with fully consented clinical data from over 13,000 OMC cancer subjects. A variety of the samples types, including normal tissues, precancerous tissues, tumor tissue, paraffin tissue, blood, saliva, DNA, as well as conditional reprogramming cell, are well preserved in the biobank. Based on the characteristics of the Chinese population, the sharing platform with unified standards has been established and over 10,000 samples have been shared with more than 120 institutes until 2019. The sample sharing system has boosted the process of fundamental and clinical research, industry progress, and technical innovation. To further improve the quality management system, more effort will be put into the platform development and sample sharing, which will ensure the sample quality and expand the storage scale to meet future requirements, and it will be a long‐term and sustainable task for the biobankers.

This work was supported by the National Program on Key Research Project of China (2016YFC0902700), Shanghai Municipal Science and Technology Commission Funded Project (18DZ2291500), and SJTU Trans‐med Awards Research (WF540162615).

Biobanking structures

PC‐01 Establishing a Cross Border Network of Biobanks in Central Europe

J. Kinkorova^{1, 2}, O. Topolčan^{1, 2}, M. Karlíková^{1, 2}, D. Seidler³, C. Brochhausen³

¹Faculty of Medicine, Pilsen, Czechia, ²University Hospital, Pilsen, Czechia, ³University Regensburg, Regensburg, Germany

Statement of the problem: International collaboration is an attribute closely connected with biobanking activities and the base to establish an interactive biobank network. For a newly established biobank from a small country, it is a big challenge to enter the multinational environment of biobanking. The first ideal step is to start a small collaborative project with partners from neighboring countries.

Proposed Solution: The Biobank of the Faculty of Medicine in Pilsen got involved in a cross‐border collaboration in 2017 with a BRoTHER project supported by the Bavarian‐Czech University Agency. BRoTHER aimed to analyze the obstacles in the collaboration of hospital‐integrated biobanks from two national health care systems: Bavaria, Germany and the Czech Republic. Two German and two Czech biobanks shared their biobanking activities, identified obstacles, and tried to find ways to overcome them. Based on the good experience of the cross‐border collaboration, a subsequent project focused on the education of medical students, future researchers, and biobankers and got funded by the Interreg programme of the European Union. This project has two partners: Regensburg University (Bavaria) and Medical University in Pilsen (Czech Republic). During these two projects, new challenges had appeared: the necessity to map the biobanking environment in both regions, to enhance the knowledge about national biobanks and to identify topics for future cooperation. A survey with the aim to identify the type, equipment, running, and/or planned projects and goals of biobanks and what they expect from the bilateral collaborations was designed and sent to Bavarian and Czech biobanks. The survey results will be analyzed and a web conference with all partners to consult the results from the completed questionnaires is planned.

The final goal of the successive projects is to enter the biobanking environment in Europe and to expand from the “nucleus” of several biobanks to a network of universities, research institutions, and industry to prepare projects proposals at a European level.

Conclusions: A network of several biobanks from neighbouring countries offers ideal first experiences to identify the objectives for future collaborations. The challenge is to share national biobanking experience and uncover differences. The next step is to harmonize biobanking processes to enable collaboration, and, finally, to attract other partners to build robust consortium for collaboration.

PC‐02 Supporting Diagnostic Research and Development with Equitable Sample Access and Sharing: Enhancing a Conventional Biobank with the Addition of FIND Integrated Biobanks (FIB) and DxConnect Virtual Biobank

I. El Idrissi¹, W. Fransman¹, A. Mantsoki¹, D. Emperador¹, A. Albertini¹, C. Ugarte‐Gil³, N. Ntusi², P. Quinlan⁴, D. Allen¹, F. Betsou¹, S. Ongarello¹

¹Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland, ²Department of Medicine, University of Cape Town, Cape Town, South Africa, ³Facultad de Medicina Alberto Hurtado, Universidad Peruana Cayetano Heredia (UPCH), Lima, Peru, ⁴UKCRC Tissue Directory and Coordination Centre, London, United Kingdom

Diagnostic research and development require the availability and accessibility of well‐characterized, high‐quality biospecimens. However:

Long‐term sustainability, fit‐for‐purpose collections, and providing equitable access to biomaterials to the entire global health community remain unresolved biobanking challenges, and more so in low‐ and middle‐income countries (LMICs).

Biomaterials from LMIC‐endemic diseases are difficult to find and biobanks are generally underdeveloped in LMICs

Over many years, FIND has been building a biobank with specimens of infectious diseases collected in and with LMICs. More recently, FIND has deployed a strategy aimed at:

Building local capacity and investing in on‐site infrastructure to deliver a long‐term, sustainable, and qualified biobanking service.

Growing a fit‐for‐purpose sample collection supporting areas of health inequalities.

Providing a transparent process of sharing and gaining access to specimens.

Increasing the visibility of pre‐existing infectious disease sample collections and collaborations between biobanks and diagnostic researchers.

FIB is a FIND‐coordinated network of biobanks that conduct collection activities to support the development of diagnostic tools. Within the FIB structure, sites based in LMICs are proactively equipped to rapidly scale‐up activities for efficient response to future pandemics. Storage of banked samples and data is being managed by the sites themselves. To ensure standardization of operations, FIND manages both FIB sites and FIND Specimen Bank sample requests and shipments. In line with FIND's pandemic preparedness program, the FIB is at present time only used for COVID‐19 sample collections but FIND plans to expand the model to its other disease programs.

DxConnect Virtual Biobank is a virtual directory of information on infectious disease collections hosted by FIND and other entities with the aim to increase their visibility and hence access to the available specimens. The DxConnect Virtual Biobank is an open‐access, free‐of‐charge facilitating platform enabling sample users and sample custodians to interact directly with one another, without needing FIND's intervention.

The newly established FIB and DxConnect VBB complement FIND's Specimen Bank by adding disease‐agnostic, in‐country capacity and network‐based biobanking capabilities. Together, they contribute to more equitable access and sharing of infectious disease samples for diagnostic research and development.

PC‐03 Enhancing the Response to Emerging Infectious Diseases: A Biobank Feasibility Study in the Philippines

D. L. Garcia¹, P. Medina², I. Cheong³, R. Lin⁴, Z. Kozlakidis⁵

¹Independent Consultant, San Mateo, California, United States, ²Research Institute for Tropical Medicine, Department of Health, Manila, Philippines, ³Smoke‐free & Healthy Life Association of Macau, Macau, China, ⁴National University Hospital Singapore, National University of Singapore, Singapore, Singapore, ⁵International Agency for Research on Cancer, World Health Organization, Lyon, France

Objective: Biobanks represent significant research and reference infrastructures underpinning the collection of specimens and associated data for clinical research. To tackle the many different needed responses to emerging and re‐emerging infectious disease pathogens, research infrastructures, in particular biobanks, have found themselves on the front line. The South‐East Asian region has experienced a number of infectious disease outbreaks in the last two decades, thus prioritizing biobanking as part of its biosecurity and research infrastructure. This abstract presents the feasibility study conducted for the potential establishment of a biobank for infectious disease pathogens in the Philippines organized through the ASEAN.

Method: The feasibility study group comprised 14 experts from ASEAN member states and 10 international expert advisors/consultants. A series of six structured online workshops and two regional meetings were organized, each one focusing on a different aspect of developing and subsequently executing the feasibility study. The workshops contained dedicated focus group discussion sections, where groups of experts would take a deep look into a specific topic, while a reporter summarized the discussions and outcomes.

Results: Three key aspects have emerged from this process:

The current landscape and impacts of the biobanks in low‐and middle‐income countries (LMICs) for infectious disease pathogens.

The creation of two independent but complementary feasibility questionnaire‐based tools: one for biosecurity aspects and one for biobanking aspects.

The implementation of those tools to a targeted location (a case study for the Philippines).

Conclusion: The consensus opinion noted is that biobank operations for infectious disease pathogens in ASEAN member states are confined into pockets of excellence, yet there is no particular methodology or framework to support their activities within a wider national and/or regional network. Therefore, the existing biosecurity capacity is limited to local impacts. The feasibility study has demonstrated that the tools developed are suitable for the particular regional context and can identify areas of challenges and opportunities for the development of future biobanking facilities, as has been shown in the case study of the Philippines. It is anticipated that the outcomes of this work will inform the creation of a regional framework for cooperation in biobanking for infectious disease pathogens.

Biodiversity/environmental/animal repositories

PD‐01 Development of Conservation Techniques for Liver Samples from Rodents of the Genus Rattus in Abidjan

A. K. Kintossou^{1, 2}

¹Biobank, Pasteur Institute of Côte d'Ivoire, Abidjan, Côte d'Ivoire, ²Training and Research Unit of Biosciences, Felix Houphouët Boigny University, Abidjan, Côte d'Ivoire

Background: Tissue samples must be preserved in liquid nitrogen immediately after excision and/or maintained at ‐80 °C for molecular biology analysis. However, researchers in Côte d'Ivoire have difficulty collecting and transporting tissue samples to areas far away from testing laboratories due to the unavailability, use, and cost of preservation equipment.

Objective: To develop and evaluate the ability of two solutions to preserve RNA from liver tissue.

Methods: Two preservation solutions named S1 and S2 were prepared to perform this experimental study. As an animal model for the experiment, we used liver tissue from 15 rats of the genus Rattus. These tissues were stored at +18 °C, +4 °C, and ‐20 °C with or without solution for two months. The amount and integrity of RNA in each sample was checked by spectrophotometry and agarose gel electrophoresis.

Results: Results from tissues stored with or without solution were compared to tissues stored at ‐196 °C (control group). Solutions S1 and S2 preserved RNA from Rattus rat liver tissue for 12 hours at room temperature (+18 °C), for three days at +4 °C, and for one month at ‐20 °C. In contrast, tissues stored without solution preserved RNA from liver tissues at +18 °C for six hours, at +4 °C for three days, and at ‐20°C for five days. Only solution S2 could preserve Rattus liver RNA for two months at ‐20 °C.

Conclusion: Solution S2 may be suitable for the preservation of RNA from the liver of Rattus rats for two months at ‐20 °C.

Keywords: preservation solutions, liver tissue, RNA integrity.

Biospecimen research, science, and outputs

PE‐01 Induced Pluripotent Stem Cells – The Next Step in the Modelling of Genetic Diseases

J. C. Moore, A. Jadali

Infinity Biologix, Piscataway, New Jersey, United States

Statement of the problem: As sequencing technologies become faster, less expensive, and more powerful, the ability to identify genetic causes of disease has become easier. Despite the advances made in identifying these genetic components, understanding their exact molecular mechanisms and developing potential treatments remains difficult for a number of reasons. Animal models are powerful, but in many cases remain difficult to generate and often cannot recapitulate the all aspects of the disease; human tissue remains hard to obtain; and the diversity of the genetic background of humans can cloud results. Since their initial generation in 2007, human‐induced pluripotent stem cells (hiPSC) have been used to model human development and disease progression, and are used for drug screening and for toxicology testing. It is now possible to reprogram a wide range of cell types allowing a greater diversity of hiPSC to be generated and increasing the availability of hiPSC containing specific mutations. These iPSC provide an excellent next step for continuing to understand and develop treatments for genetic diseases – they are human, they can be differentiated into any cell type, and they can be used in a relatively high‐throughput manner.

Having a repository/centralized location where researchers could access iPSC lines from a multitude of diseases, distinguishable based on age, sex, as well as type of mutational profile, would help facilitate a more cost‐effective and less time‐consuming resource for researchers and thus enhance the productivity of the research study itself.

Proposed solution and conclusion: Infinity BiologiX maintains multiple NIH and non‐profit stem cell repositories including the NINDS Cell and Human Data Repository (https://bioq.nindsgenetics.org/) and the NIMH Repository & Genomics Resource (https://www.nimhgenetics.org/). These repositories house iPSC, fibroblasts, and cryopreserved lymphocytes from more than a 1,000 subjects, including a GMP‐grade iPSC cell line. These cell lines are available to academic and for‐profit researchers worldwide.

PE‐02

Withdrawn

PE‐03 SMART Tube Whole Blood Biobanking for Downstream Flow Cytometry

P. Lambert¹, W. Ammerlaan¹, G. Radicchio², A. Cosma²

¹Integrated Biobank of Luxembourg, Luxembourg Institute of Health, Dudelange, Luxembourg, ²National Cytometry Platform, Luxembourg Institute of Health, Esch‐sur‐Alzette, Luxembourg

Background: Immuno‐phenotyping of patient peripheral blood mononuclear cells (PBMC) by flow cytometry is a commonly used technique for disease monitoring. The associated pre‐analytical variabilities are linked to the sample collection, transport, processing, and/or storage. Additionally, PBMC isolation, counting, and storage is a task requiring experienced operators and appropriate instrumentation, which may not be accessible in close proximity of the sample collection or within an acceptable period after specimen collection.

To overcome these problems, SMART TUBE Inc. developed a stabilization buffer that fixes the whole blood within 20 minutes into an appropriate state for flow cytometry and also permits subsequent cryopreservation at ‐80 °C, thereby avoiding the constraints of liquid nitrogen use. The fixed whole blood could be stored temporarily on the collection side and transported on dry ice in batches to flow cytometry core laboratories for analysis or to biobanks for long‐term storage.

Method: To evaluate the efficacy of the SMART TUBE buffer and methodology, we analyzed immuno‐phenotype profile of cells prepared the SMART TUBE technology by flow cytometry and compared it with standard PBMC cryopreservation and fresh whole blood staining.

Results: Our results show that the majority of the tested markers (CD3, CD4, CD8, CD11c, CD13, CD14, CD16, CD19, CD45, CD56, CD66b, CD123, and HLA‐DR) were not significantly affected by the SMART TUBE fixation process. Some antibodies, however, needed to be titrated in the new setting to obtain results similar to fresh whole blood staining, suggesting changes in the epitope exposure following fixation with SMART TUBE.

Conclusion: We concluded that SMART TUBE buffer is a powerful tool to simplify and standardize pre‐analytical handling in situations where sample collection is performed in settings physically remote from the standard processing site. However, the investigator must make sure that their antibody panel is compatible with the stabilization procedure.

PE‐04 Optimization of Ambient Temperature Storage of Nucleic Acids

T. Moshma¹, E. Mayne², M. Gededzha¹, N. Mampeule¹

¹ISmmunology, Witwatersrand, Johannesburg, Gauteng, South Africa, ²University of cape town, Cape Town, Western Cape, South Africa

Background: H3 Africa aims to study the African genetic determinants of disease while increasing capacity for high quality genetic research on the African continent. In order to ensure sustainability and make biobanking attractive in low and middle income settings across Africa, there is a need to develop innovative storage solutions while retaining quality. To optimize storage protocols, the biorepository is looking at implementation and design of more cost‐efficient solutions.

Aim: The aim of this study was to optimize ambient storage solutions for nucleic acids at the H3Africa/CLS Biorepository, located in Johannesburg.

Methods: Nineteen EDTA samples submitted for FBC counts at CLS were collected. DNA and RNA was extracted from whole blood and DBS using an automated Hamilton Microlab STAR and QIAamp RNA blood kit, respectively. 10μl of extracted nucleic acids were equally aliquoted onto tubes correctly labelled and stored at different temperature points; RT, 2‐8 °C, ‐80 °C, and 40‐50 °C for periods of 24 hrs, 96 hrs, 30 days, and 90 days. Extracted DNA/RNA were tested on the Nanodrop for concentration and purity, and 0.8% gel electrophoresis for quality. The Agilent bioanalyzer was used to test for DNA/RNA integrity.

Results: Across all samples, initial DNA and RNA concentrations were higher than concentrations of aliquots containing storage solutions stored. RNA concentration for Samples 1 and 4 that were not stored in storage solution revealed that RNA stored at 50 °C and RT for 24 hrs and 96 hrs were extremely high with poor purity as compared to those stored at 2‐8 °C and ‐80 °C. Aliquots stored in RNA storage solution stored at 50 °C for periods 24 hrs and 96 hrs had extremely high temperature and poor purity compared to those stored at ‐80 °C, and extremely low temperature at periods of 30 days and 90 days. There was less difference in RNA concentration between aliquots stored at ‐80 °C and those stored at RT and 2‐8 °C for all storage periods. Gel electrophoresis results showed that DNA stored inside storage solution has low bands as compared to initial results. Agilent bioanalyzer integrity results showed that aliquots stored at 50 °C for 96 hours with adsorption beads and RNA storage solution had an RIN value <4.5 as compared with aliquots stored at RT, 2‐8 °C and ‐80 °C which had RIN values >6.0.

Conclusion: The preliminary results indicate that DNA and RNA stored in different support mediums remains stable and it can be used for downstream application.

PE‐05 A Prospective Breast Cancer Biobank from Single Institutional Cohort

L. Busheri^{2, 1}, P. Kanase^{2, 1}, D. Yadav^{2, 1}, R. Banale^{2, 1}, R. Alhat¹, G. Thomas¹, R. Navgire¹, S. Nare^{1, 2}, C. Deshmukh¹, D. A. Kelkar^{1, 2}, M. Kulkarni^{1, 2}, C. B. Koppiker^{1, 2}

¹Prashanti Cancer Care Mission, Pune, Maharashtra, India, ²Centre for Translational Cancer Research (CTCR), A joint initiative of IISER Pune and PCCM, Pune, Pune, Maharashtra, India

Background: In India, breast cancer incidence is increasing at a higher rate than overall cancer incidence. It is worrying that Indian mortality rates continue to be higher than the global breast cancer mortality rate. Molecular tools developed based on data from western cohorts are routinely included in their clinical workflow. However, since the clinical presentation of breast cancer in India is distinct from western cohorts, these tools might have limited utility to Indian clinicians. There is therefore a marked need for molecular and clinical data of breast cancer cohorts from the Indian population. As a means toward fulfilling this need, PCCM established a retrospective breast cancer biobank to collect patient data and associated formalin‐fixed, paraffin‐embedded (FFPE) tissue blocks in 2018. This biobank is based on the practice of a single breast clinic, therefore minimizing heterogeneity due to clinician bias. The biobank entered the prospective phase in 2019.

Methods: After appropriate ethical approvals and patient consent, clinical data and the tissue sample collection were undertaken for the prospective biobank. In addition to the specimens of FFPE tumor tissue with adjacent normal, sentinel nodes, and axillary nodes, the biobank consists of information based on the patient's clinical history, diagnostic reports, treatment, and follow‐up. Pathological data are collected from diagnostic reports in Excel using a rigorously defined vocabulary. Clinical data are collected from manually entered forms, imaging reports, and clinician notes in a SQLite database using a customized data entry tool.

Results: We have earlier reported the audit of the retrospective biobank. Here, we report the update of the FFPE tissue biobank. A total of 806 patients with breast disease have deposited their clinical records in the biobank. Most cases are infiltrating ductal carcinoma. FFPE blocks from 654 patients are deposited in the biobank. These include both benign and malignant tissue.

Conclusion: The PCCM FFPE biobank in the prospective phase has improved sample collection methodology in comparison to the retrospective phase. Tissue samples from the retrospective biobank and from this prospective dataset have been used in promising translation studies in addition to the development of clinical research studies. This biobank is and will be a valuable resource for the breast cancer research community.

PE‐06 Persistent Organic Pollutants in Bristol Bay Beluga Whales, Delphinapterus leucas

J. Hoguet¹, A. Rodowa¹, M. Cheng², T. Rowles³, R. S. Pugh¹

¹NIST, Charleston, South Carolina, United States, ²Middlesex, Concord, Massachusetts, United States, ³NOAA, Silver Spring, Maryland, United States

Remote, high‐latitude locations are often sinks for persistent organic pollutants (POPs), which can bioaccumulate in local wildlife such as beluga whales (Delphinapterus leucas). Of those inhabiting Alaskan waters, Bristol Bay belugas represent a healthy and stable population with ∼2000 individuals. Conversely, the Cook Inlet population has been in decline, and despite protective measures, is not recovering with less than 300 individuals remaining. To understand the decline of this sensitive population, health assessments of wild Bristol Bay belugas were conducted to obtain baseline parameters from a stable population from which to compare. This highly collaborative monitoring effort (e.g., federal and state agencies, aquariums, native associations) was conducted between 2008 and 2016. Of the samples collected, blubber and blood tissues were cryogenically archived at the National Institute of Standards and Technology's Biorepository in Charleston, South Carolina, for retrospective analysis. Of those archived tissues, blubber from 50 beluga whales was analyzed for POPs (e.g., polychlorinated biphenyls, chlorinated pesticides, polybrominated diphenyl ethers, and hexabromocyclododecanes). The preliminary data and findings are presented here. POPs concentrations in Bristol Bay beluga were also compared to those in beluga from both Cook Inlet and the eastern Chukchi Sea, other geographically distinct beluga populations. Bristol Bay beluga POPs concentrations were comparatively lower than concentrations in both Cook Inlet and eastern Chukchi Sea beluga, lending to the Bristol Bay population's viability as a baseline population for future POPs measurements.

PE‐07 Complementary High‐Throughput RNA Extraction Conducive to Multi‐Omic Characterization of Pediatric Central Nervous System Tumors

R. Heromin¹, I. Gonzalez‐Gomez¹, G. Jallo^{1, 2}, B. Lopes¹, H. Monforte¹, S. Stapleton^{1, 2}, W. Schleif¹

¹Johns Hopkins All Children's Hospital, St. Petersburg, Florida, United States, ²Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Statement of the problem: Processes for tissue procurement and its allocation for research are highly individualized across institutions and depend on the availability of staff, infrastructure, and specific needs. A lack of standardization creates preanalytical variation and limits expansion of larger centralized biobanking activities. It is also presently unclear if snap‐frozen or optimally handled formalin‐fixed, paraffin‐embedded (FFPE) tissues meet the criteria for emerging sequencing technologies, particularly when attempting to characterize long‐read RNA isoforms with other multi‐omic approaches.

Proposed Solution: We present an extension of our institutional model for high‐throughput tissue homogenization for DNA extraction (presented at the ISBER 2019 regional meeting) that couples with a parallel process for immediate stabilization and automated extraction of total RNA, designed to optimize the quality of very small biobanked derivatives from a cohort of pediatric central nervous system (CNS) tumors. Following delivery from the operating room and release by the neuropathologist, a representative tumor sample is split into several derivatives, each optimized for a specific purpose. For downstream RNA analysis, a tumor portion is split off and placed into a commercially available RNA stabilizing solution in an off‐label use prior to freezing at ‐80 °C, whereas the bulk of remaining tumor is snap‐frozen using liquid nitrogen and aliquots placed for FFPE. The snap‐frozen samples are kept in long‐term storage for other uses. Tissue homogenization of the stabilized derivatives using bead‐beating and controlled forces of 6 m/s are performed in batch, followed by automated extractions using paramagnetic beads.

Conclusions: Our pilot approach provides a new alternative to traditional methods for tissue‐derived RNA preservation that is readily adoptable at other institutions. RNA specific quality metrics (260/280 ratios, RNA quality scores, and yields) will be presented from a 39 case sub‐cohort of pediatric CNS tumors with previously assessed DNA characteristics. The results provide an early estimate of the utility of this optimized precision model for standardizing the collection of tumor samples for biobanking.

PO‐05 Transient Warming Events Impact Ice Recrystallization in RCCs Cryopreserved Using the High and Low Glycerol Freezing Methods

N. William², A. Rahman², C. Olafson¹, J. P. Acker^{1, 2}

¹Innovation & Portfolio Management, Canadian Blood Services, Edmonton, Alberta, Canada, ²Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada

Background: Clinical red cell concentrate (RCC) cryopreservation strategies use either 40% or 15% glycerol in what have been termed the high‐ and low‐glycerol methods (H/LGM), respectively. Reducing the glycerol concentration from 40% to 15% is made possible through the combined use of rapid freezing rates (∼60 °C/min vs. 1 °C/min) and lower storage temperatures (‐196 °C vs. ‐80 °C). Rapid freezing rates and lower glycerol concentrations decrease the ice crystals' thermodynamic stability, which could in turn make LGM‐cryopreserved units more susceptible to ice recrystallization injury when routine inventory management or freezer failures result in transient warming events (TWEs). Thus, we sought to compare TWE‐mediated ice recrystallization between these two freezing methods.

Methods: Freezing profiles were mapped using K‐type thermocouples in units that were processed using both the high‐ and low‐glycerol methods. “Fast” and “slow” TWE profiles were determined by placing units either at room temperature or in a ‐20 °C freezer, respectively, and returning them to standard storage conditions once they reached ‐20 °C. These freezing profiles were then reproduced on a microscope‐mounted cryostage. Images were captured for the LGM and HGM following the initial freezing event and upon exposure to three “fast” and “slow” TWEs (n = 3). Quantification of the ice crystal mean grain size, a predominant marker of recrystallization, was performed using NIS elements AR (v. 3.2).

Results: Ice crystal mean grain size increased during transient warming. As was expected due to the faster cooling rate, the LGM yielded ice crystals with significantly smaller mean grain size than the HGM (p = 0.0005). Inter‐method comparisons of the TWE rate demonstrated that “slow” TWEs yielded a larger mean grain size (LGM: p = 0.023; HGM: p = 0.0041). In contrast, there were no such differences when comparing each rate of TWE between the LGM and HGM. [JPA1] Similarly, the overall increase in mean grain size following “slow” and “fast” TWEs did not prove to be significantly different between the two freezing methods.

Conclusion: RCCs cryopreserved using either the HGM or LGM experience significant ice recrystallization which may make them more prone to damage during TWEs. When paired with future quality assessments, this work will help inform decisions pertaining to the management of frozen blood product inventories that undergo transient warming excursions.

Ethical, legal, and social issues

PF‐01 Effects of Introduced and Cold‐Call on Participation Rates for Biobanking

C. J. Cook, A. K. Cato, H. Chavarria, S. J. McCall

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

Background: Biobank participation rates are historically high (86.0% during the COVID‐19 pandemic [Gao et al., 2021]) but vary with specific details (67.1% participation rate for data/biospecimen sharing [Kim et al., 2019]). Regulatory advancements allowed the Duke University Health System (DUHS) BioRepository and Precision Pathology Center (BRPC) to use new methods for obtaining patient consent during COVID‐19. These included a 2020 electronic consent option (e‐consent) which permitted patients to electronically sign consent via a secure email link. Further, DUHS moved to a global “opt‐out” (via the Notice of Privacy Practices) for all research. This allowed BRPC staff to contact, or cold‐call, patients directly (without clinician introduction) in 2021. This study examines the effect of these two changes on participation rates experienced at BRPC.

Methods: BRPC participation rates from January 2019 to November 2021 were analyzed based on percent acceptance rates (number of consents/total approaches), whether approaches were introduced by clinician and whether paper or e‐consent was completed. BRPC results in different groups were compared and all participation rates were analyzed against published data from similar studies.

Results: In 2019, BRPC paper consent participation rates were 92%. In 2020, BRPC's participation rate using paper consent was 87% and e‐Consent was 99%; e‐consent was used in 2020 only as a follow‐up to an introduction. In 2021, the participation rate for paper consent was 90% and e‐Consent was 86%. In 2021, e‐consent was used as follow‐up to provider introduction as well as a “cold‐call” format. In 2021, 40% of approaches were cold call. Consent success rate was 93% among provider‐introduced approaches and 82% for cold‐call approaches. E‐consent comprised 33% of total approaches in 2020 and 46% in 2021.

Conclusion: Participation rates for all consent methods varied but were generally equivalent/higher than publicly‐reported rates for biorepositories. The decline in e‐Consent success rate in 2021 can be attributed to the cold‐call rollout; more patients were approached who had not expressed prior verbal interest in the biobank. Consent success rate was higher through provider introduction when compared to the cold‐call approach. An increased proportion of approaches in 2020‐2021 have used the e‐consent, which has allowed BRPC staff to approach patients conveniently and improve post‐consent workflow efficiency.

PF‐02 Informed Consent Models in Biobanking: Results from a Systematic Review

C. Lewis

Northern Ireland Biobank, Queen's University Belfast, Belfast, County Antrim, United Kingdom

Background: There has been increasing debate about the most appropriate method of obtaining informed consent for biobanking, particularly whether biobanks should adopt a one‐time or study‐specific model of consent. Most biobanks opt for a one‐time model where consent is obtained at the time of sample collection and is provided only once. This approach is thought to be the most efficient for biobanks and is recognized as a valid model of biobank consent. However, it is contested by some critics who claim it does not offer the protection of full informed consent; they argue that consent can only be fully informed if it is obtained each time a sample is requested for use; i.e., “study‐specific.” In turn, this model has been regarded as impractical since it would place a substantial resource burden on biobanks to re‐consent participants every time their sample was used. Numerous empirical studies have been conducted to investigate the preferences for biobank consent but with variable conclusions.

Methods: This systematic review followed the methods set out in The Preferred Reporting Items for Systematic Reviews and Meta‐Analyses Statement. Studies were retrieved following searches of four databases (CINAHL, MEDLINE, EMBASE, and Web of Science) for empirical research studies which reported on the preferred methods/approaches to informed consent for biobanking published until July 30, 2019.

Results: A total of 43 studies were included for review: 23 quantitative, 16 qualitative, and four mixed‐methods studies. In studies where quantitative data were reported about preferred model of consent (n = 24), 21 reported in favor of a one‐time model of consent, one in favor of a study specific model of consent, and two studies reported no overall preference. Qualitative data indicated a preference for one‐time consent for reasons including less hassle and desire to advance research. Five studies reported on desired format of consent; participants preferred the introduction to the biobank was made initially by a healthcare professional involved in their care and that consent should be face‐to‐face. There was a striking lack of consensus on how models of consent are defined in the literature.

Conclusions: Findings indicate that patients prefer a one‐time model of consent. There was less evidence to suggest a preferred format of consent. Better quality studies are needed, and standardization of definitions of consent models in biobanking to facilitate study comparison.

PF‐03 Willingness to Donate and to Receive Results: Should We Return to Donors with Research Findings?

A. Ovcharenko

MOH, MIDGAM, Rehovot, Israel

Background: Israel, like many other countries, enters an era of large longitudinal studies, often genetic, in personalized medicine, conducted mainly as part of the National Digital Health Projects. These studies are based on biosamples and annotated data (demographic, clinical, genetic, behavioral, etc.). MIDGAM, The Israeli National Biobank for Research, established in 2014, promotes biomedical research in Israel, and as such is the best platform for such projects.

Methods: To assess population willingness to contribute to these studies including willingness to donate and to receive results, 1,607 men and women (general population: N = 922; ultra‐orthodox sector: N = 384; Arab sector: N = 301) were asked to fill out a quantitative survey questionnaire. Subjects were asked about their willingness to donate biosamples and data, and their opinions regarding receiving results including incidental findings. Specific focus was given to genetic data.

Results: We found that within the general population 52% are willing to donate; most willing subjects are also interested in receiving results (40% of all respondents, 77% of those willing to donate). We also found that the main barriers to sample donation were related to concerns about data leakage, privacy violations, and lack of understanding of the purpose of donation. The (relatively small) part of the population not interested in receiving findings cites mainly reluctance to know.

Conclusions: To meet the needs inferred from these results, we adjust and update our consent and explanatory materials. It is important to continually examine the significance of research findings for clinical purposes. To that end, findings with medical significance and therapeutic potential should be regularly updated and shared according to clinical guidelines. In addition, a dedicated professional committee will be established to discuss the implications of incidental findings and examination of donors' expectations.

PF‐06 Enhanced Lay Involvement for Improved Biobanking

A. Parry‐Jones

Wales Cancer Biobank, Cardiff University, Cardiff, United Kingdom

Background: The Wales Cancer Biobank (WCB) has involved the public and patients since its inception in 2004. Four lay representatives sat on the original Steering committee to define the biobank and these four individuals formed the nucleus of the Lay Liaison and Ethics group who worked with the biobank senior team to draft the patient information sheet, consent form, and the application to the ethics board. This group continued to meet as a distinct group for 15 years to work with the biobank to consult on new initiatives, advise on amendments to ethics, and give their lived experiences. Although the Chair of the lay group was a member of the Executive group, other lay members had little to no direct input and contact with the wider biobank staff and management. To improve engagement, involvement, and governance a radical rethink and overhaul of lay contribution was considered in 2019.

Method: In 2020 the way the lay group interacted with the biobank changed considerably and members of the lay group were introduced to each of the biobank working committees. In this new structure, two members joined the Operational Management group, and one member joined the Strategy group, whilst retaining the Chair's involvement in both the Executive and Advisory groups. A group of members also reviews the lay summaries as part of the Applications review panel to ensure the text is truly lay and public friendly. As full members of the committees, lay members receive all the papers and reports and are encouraged to participate equally in meetings.

Results: Feedback from the lay members has been hugely positive and all have reported feeling better informed, more involved, and more valued. The members on the operational management group have commented that they had no idea the day‐to‐day operation was so complex and that the increased knowledge had changed the way they participate and the recommendations they contribute. A lay driven conversation has, for example, initiated the production of two videos aimed at the public to raise awareness and a major refresh of the website.

Conclusion: An informed lay voice has greater value to the biobank and gives greater purpose to the volunteer. Embedding the lay representatives at the heart of all activity speaks to the vision of the biobank of improving impact and adding value by not only listening to lay representatives, but truly involving them in governance decisions that impact priorities and future agendas to improve outcomes.

PF‐07 Improvement of SingHealth Tissue Repository (STR) Broad Consent Form

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

SingHealth Tissue Repository, Singapore Health Services Pte Ltd, Singapore, Singapore

Statement of the problem: In Singapore, biobanking of human tissue for research is governed by the Human Biomedical Research Act (HBRA) which requires informed consent from the donor. Such consent must be obtained in writing from tissue donors or their legal proxies. The required consent elements listed in section 12(2) of HBRA must be clearly explained to the donor and documented to be understood, in the presence of a witness. Informed consent is an important ethical and legal requirement in human research. STR implemented a broad consent form with separate information sheet which fulfill HBRA requirements since 2017. However, these documents were complex in design and difficult to complete. About 19% of 1,059 cases targeted for tissue banking were unsuccessful in 2018 because the consent forms were incompletely filled in, had missing donor and witness declaration, and errors due to confusion over definitions of “leftover” and “extra” material.

Proposed Solution: Thus, STR revamped the consent form with the aim of making it clearer and simpler to complete. The new version has three main changes. Firstly, the information sheet and consent form were merged into a single document with a clearer section related to donation. Secondly, the four questions on consent elements (re‐contact for future consent, re‐identification for incidental findings, send donated material overseas for research, and use of material in restricted research) were removed to reflect streamlined tissue bank policies on these four elements as described in detail in the information sheet. Thirdly, multiple redundant check boxes were eliminated and converted to bullet points to avoid the situation of an incomplete consent form due to inadvertent omission of checks in the boxes. Following the changes, the number of sections required to be completed in the new version is reduced to 17 from 29 in the existing consent form.

Conclusion: In conclusion, the new version of consent form is designed to enhance the consent process and to facilitate understanding of the donation process. We also aim to improve overall satisfaction of tissue donors, consent takers, and healthcare workers involved in biobanking.

Hot topics

PG‐01 Keeping an Eye on COVID: CONSERVE Seroprevalence Study For Healthcare Workers For Antibody Testing Over A One Year Period

R. Singh^{1, 2}, B. Tiffany³, R. Bremner⁴, J. Eschbacher⁵, S. Bowen¹, J. Cogo⁵

¹Biobank Core Facility, Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, ²Barrow Neurological Institute, Phoenix, Arizona, United States, ³Dignity Health Research Institute, Phoenix, Arizona, United States, ⁴Dignity Health Norton Thoracic Institute, Phoenix, Arizona, United States, ⁵St Joseph's Hospital & Medical Center, Phoenix, Arizona, United States

In the final weeks of March 2020, as the number of hospitalizations and deaths related to COVID‐19 was rapidly increasing, it was clear that there were few definitive answers as to the exact mode of transmission, virulence, and lethality of SARS‐CoV‐2. While people were still advised to sanitize groceries before bringing them into their homes, the research team in the Arizona Division of Dignity Health (DH) was mobilizing to conduct an ambitious, multi‐site, year‐long project. The goal was to collect whole blood samples from DH employees every three months for a total of five time‐points. Each draw was conducted only after a subject completed an online wellness survey and answered questions about the nature of their jobs in healthcare. The project faced multiple layers of challenges. Enrolling and retaining volunteers at a time when hospital staff were experiencing unprecedented levels of burn‐out was difficult. Each of the five participating institutions had unique patient registration workflows. And at the onset of collection, the testing methods intended for the banked specimens were not yet available. After working with hospital labs to ensure feasibility, specimens were assayed using the Abbott Architect platform to semi‐quantitatively evaluate SARS‐CoV‐2 IgG seroprevalence. Clinical results were then shared with subjects through the patient portal as an incentive to participate. Informed consent, data capture, and clinical data reporting were all accomplished electronically in order to streamline the enrollment process across all sites. In anticipation of emerging testing platforms, whole blood specimens were processed for plasma and serum before being stored as ten 0.5‐1 mL aliquots.

Of the more than 1,300 subjects initially enrolled, 84.5% completed 3+ draws, and 54.2% completed the entire series. Only 6.48% of subjects withdrew after the first time point. Analyses are currently underway; as of November 15, 2021, at least one aliquot of all draws for every participant (5,375+ individual samples) had been shipped to collaborators to: determine if there are any differences in seroprevalence of patient‐facing employees compared to their more sequestered colleagues, the rate of decline in antibody levels, and any correlation between perceived wellness scores and measured SARS‐CoV‐2 immune responses. Preliminary results from a fraction of the subjects (350 subjects with all five draws each) indicate a <3% breakthrough infection rate after vaccination.

PG‐03 Overcoming Natural and Socio‐economic Challenges in Biobanking: Examples from USA and Nigeria

T. Petrachkova¹, M. Chergova¹, A. Giardina¹, J. Cvitanovic¹, J. Okafor², R. Semikov¹

¹Audubon Bioscience, Houston, Texas, United States, ²Audubon Bioscience, Abuja, Nigeria

Biobanking has become an integral part of biomedical research. The future of precision medicine depends on high‐quality specimens and, therefore, an adequate specimen collection design. At Audubon Bioscience, we procure high‐quality specimens from diverse populations for cutting‐edge private and academic translational research, mainly in the field of cancer biology. Here, we focus on the prospective specimen collection, processing, and storage challenges in the USA and Nigeria.

In both countries, we work on prospective collections of single and matched specimens, including whole blood, plasma, serum, buffy coat, and FFPE tissue blocks. While biobanking in the USA comes with smooth and regulated operations, unexpected natural disasters pose a high risk to biospecimens collection, storage, and logistics. In 2021, our operations in New Orleans, LA, faced the challenges associated with the category four hurricane Ida. Lack of electricity and overall damage caused by the hurricane disrupted operations for a month. To overcome this, our team prepared and successfully executed a hurricane/disaster plan. The process of developing and executing this plan could be successfully used as an example in developing contingency plans in case of disasters.

As the scientific world recognizes the lack of ethnic diversity in biomedical and genetic research, African countries have become more involved in biobanking in the past decade. Even though Nigeria is the leading economy in Africa, in contrast to the USA, day‐to‐day operations face various non‐natural disasters, such as continuous unpredicted loss of power supply and limited access to dry ice. To overcome this, collection sites, such as clinics and hospitals, use generators and power sets to maintain freezers and ultra‐low freezers working, and solar panels to power generators and provide enough local power supply. Although it arises from a socio‐economical necessity, this strategy can be successfully applied against multiple disaster scenarios in other countries.

Operating in countries of diverse opportunities and supplies offers us a chance to adjust and provide innovative solutions inspired by both settings. This experience shows the possibility of finding solutions and developing effective disaster plans in both high‐ and low‐income countries.

PG‐04 Investigation into the Effects of CO2 on Quality of SARS‐CoV‐2 Clinical Specimens

V. Zhang, P. Chan, M. Ng

Biospecimen Acquisition & Management, Roche Diagnostics, Pleasanton, California, United States

During the SARS‐CoV‐2 pandemic, reliable COVID PCR tests play a critical role in identifying and controlling the spread of the virus. Common COVID PCR tests require a nasopharyngeal swab specimen to be collected from a patient. After collection, the swab specimen is stored in UTM (Universal Transport Medium), which is a medium formulated to preserve viral clinical specimens. The UTM formula contains a pH indicator, phenol red, to show when a sample is acidic (yellow), neutral (red), or basic (purple) to quickly assess the specimen quality. A specimen pH that shifts to acidic or basic could indicate a number of issues including sample contamination or improper specimen handling. Over the course of the pandemic, the Biospecimen and Acquisition Management (BAM) team at Roche Diagnostics has acquired many COVID specimens from clinical sites and found them to range in color from yellow to red, raising questions about the sample's quality and stability. To address these concerns, the BAM team designed an experiment to examine different parameters during sample collection and transport that could cause the samples to change colors. The results of this experiment show that exposure to CO2 from the dry ice during shipment can cause the sample to acidify, which could then compromise PCR test performance. Additionally, the BAM team is collaborating with Roche Research & Development teams to examine how an acidified sample, whether by CO2 exposure or bacterial contamination, may impact COVID PCR test results.

Human specimen repositories

PH‐01 Biobank‐driven Approach to Precision Medicine for the Underrepresented African Population

Y. Ibrahim¹, M. Kashimawo², M. Oyewale¹, E. Onabowale¹, 5. Research Team³, J. Popoola¹

¹Molecular Genetics and Biobank Operations, 54gene, Lekki Phase 2, Lagos, Nigeria, ²Molecular Genetics and Biobank Operations, 54gene, Lekki Phase 2, Lagos, Nigeria, ³Research Governance and Ethics, 54gene, Lekki Phase 2, Lagos, Nigeria

Biobanking has become the new gold standard providing resources for archiving and access to phenotypic, genotypic, demographic, and clinical data of consenting individuals towards achieving a multitude of aims. The importance of biobanking has become more emphasized with the advent of pharmacogenetics, precision medicine, and the global effort to identify genetic variants and associations through approaches like Genome‐Wide Association Studies (GWAS) and modern molecular‐based research.

Despite the progress made over the years, there is still a significant variation between lower‐ and higher‐income countries, with underrepresented populations suffering a greater inequality. For example, Africa, which is the most genetically diverse population, has contributed less than 5% of the global genetic data driving research. This is a concern for the future of global medicine, as excerpts from genetic diversity within the African genome can lead to a better understanding, treatment, and management of diseases for both Africans and the global populations. We report on our efforts towards addressing this gap.

We began by establishing a research collaboration between 54gene and multiple research institutions. High‐quality samples were collected from participants and received in the 54gene biobank following acceptance criteria, with accompanying consent and phenotypic data. The 54gene biobank is equipped with state‐of‐the‐art storage facilities to maintain sample integrity.

We established a world‐class molecular genetics laboratory capable of utilizing Next‐Generation Sequencing technology for generating the genetic data required to drive precision medicine. Using the Illumina Novaseq 6000, we whole‐genome sequenced representative samples in order to identify known and unknown genetic variations associated with health and diseases in samples from African populations. Finally, we employed genome‐wide genotyping as a streamlined and cost‐effective high‐throughput approach to studying genetic variation and diversity on a wider scale.

Information from data generated from these processes will be very useful in bridging the gap and equalizing precision medicine globally. Armed with these data sets, we will be able to study regions of interest within the African genome and find clinically significant correlations that will drive innovative therapies within the African continent and globally.

PH‐02 The Cooperative Human Tissue Network (CHTN) Midwestern Division Uses Whole Slide Images (WSIs) for Pathologist QC Review of Each Distributed Tissue for Lesion Type and % Tumor.

R. Mandt, D. G. Nohle, K. Shilo, L. W. Ayers, A. Parwani

CHTN‐MW Division, Columbus, Ohio, United States

Background: Cooperative Human Tissue Network, Midwestern Division (CHTN MWD) is a contributing Division of the National Cancer Institute (NCI/NIH)‐sponsored prospective human research tissue procurement program providing quality human research tissues, approved demographic, and clinical data to approved investigators. One objective is to ensure that each NCI‐funded cancer researcher has sufficient, appropriate cancer tissue, controls, and data resources to support their stated/funded goals. Each tissue must pass a pathologist quality control (QC) review.

Methods: Remnant tissues are procured from fully patient‐consented, medically‐indicated surgical cases and from consented autopsies. The collection includes a representative tissue section that is processed, cut, and stained with H&E stain, scanned, and placed in batches for QC review. Data related to the collection, processing, distribution, and transient storage of tissue samples and QC WSIs is maintained in CHTN MWD Research Tissue Procurement ‐ Information System (RTP‐IS).

Results: Of the 4,370 WSIs reviewed, 3,930 (89.9%) passed the review, 70 (1.6%) were passed as benign, and 202 (4.6%) failed QC review. Additionally, two (0.05%) passed adjusted to normal, 73 (1.7%) passed with other adjustments, and 93 (2.1%) failed as wrong.

Of these 4,370 WSIs reviewed, 2,991 (68.4%) were Malignant tissue type, 807 (18.5%) Normal Adjacent, 464 (10.6%) Benign, 102 (2.3%) Normal, and 6 (0.1%) Not Applicable.

The WSIs are stored in the RTP‐IS and are available to the researcher should questions arise. WSIs are also available for distribution to investigators interested in developing algorithms using AI and WSIs.

Conclusions: The use of WSIs for QC allows the QC batch to be easily assembled and transmitted electronically to the QC pathologist. Their review can be conducted at work or at home depending on computer resources. WSIs can be stored in a computer management system such as our RTP‐IS. The availability of WSIs of a variety of cancer histopathology types, custom‐collected for the investigator with associated minimal demographics, presents a significant resource to local and national researchers.

The CHTN national website (https://www.chtn.org/) is a valuable source of information and a gateway to access the on‐demand repository. Researchers including pathologists can create customized protocols including those that focus on AI and image analysis research.

PH‐03 The PROCURE Biobank: A Precious Tool for Prostate Cancer Research

G. McKercher¹, A. Bergeron², S. Chevalier¹, M. Wissing¹, A. Mes‐Masson³, A. Piché⁴, F. Brimo¹, M. Latour³, N. Ekindi‐Ndongo⁴, M. Carmel⁴, L. Lacombe², F. Saad³, A. Aprikian¹

¹McGill University Health Center (MUHC), McGill University and Research Institute of MUHC, Montreal, Québec, Canada, ²Centre hospitalier universitaire de Québec, Université Laval (CHUQc‐UL) et Centre de recherche du CHUQc‐UL, Québec, Québec, Canada, ³Centre hospitalier de l'Université de Montréal (CHUM), Université de Montréal et Centre de recherche du CHUM, Montréal, Québec, Canada, ⁴Centre hospitalier universitaire de Sherbrooke (CHUS), Université de Sherbrooke et Centre de recherche du CHUS, Sherbrooke, Québec, Canada

Background: Research on prostate cancer (PCa) is often impaired by lack of high‐quality biospecimens and clinical data. To fulfill this need, PROCURE, with a team of urologists, scientists, and pathologists, has created a multi‐site biorepository of biospecimens and associated clinical data of patients undergoing radical prostatectomy (RP) for their cancer and who are followed longitudinally during remission or recurrence of their disease.

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

Results: From 2006 to 2013, the biobank enrolled 2007 men. Blood (serum, plasma, buffy coat), urine, and prostate tissues (frozen and FFPE) obtained at RP were banked. Clinico‐pathological data were collected in the ATiM database and updated periodically. Follow‐up visits permitted blood and urine recollection. Mean age of participants at diagnosis was 62 and mean prostate specific antigen (PSA) was 7.9 ng/mL. The distribution of Gleason grades (GG) at RP [GG1 (15%), GG2 (47%), GG3 (22%), GG4 (8%) and GG5 (8%)] and tumor stages [pT2 (62%), pT3a (27%) and pT3b (11%)] correspond to reported values for RP cohorts. Current median follow‐up time is 93.6 months. To date, 658 participants had a biochemical recurrence (33%), and 200 deaths (10%) were recorded, among which 47 (2.3%) were due to PCa. Clinical data (PSA value, recurrence, treatments) were updated for at least five years post‐RP for 86% of the cohort.

In 2021, more than 10,500 collections of blood and urine have been registered, including 8,500 at follow‐up visits. A majority of participants (87%) have provided additional samples after RP. A tissue microarray composed of benign and cancer tissue cores from 1,638 participants was generated. Blood and tissue DNA along with RNA and histopathology of frozen vs fixed tissues confirmed the reliability and quality of longitudinally banked material.

Conclusions: The PROCURE Biobank has reached sufficient maturity to allocate high‐quality biospecimens and data to the biomedical and scientific community. The long clinical follow‐up, rich outcome data, and blood sampling throughout patient trajectory make this biobank a most precious model to conduct innovative research towards a better understanding, detection, and treatment of PCa.

PH‐04 Call for Action Towards Rare Diseases and Associated Health Innovation in South Africa

E. H. Conradie, B. C. Vorster, M. Dercksen

Centre for Human Metabolomics, North‐West University, Potchefstroom, North‐West Province, South Africa

Statement of the problem: South Africa (SA) and many other developing countries face a tremendous challenge when it comes to healthcare of its diverse society. A large number of the population is affected by human immunodeficiency virus and tuberculosis, respectively, accounting for 17% and 5% of the global disease burden. Even though government acknowledge the further burden placed on the healthcare system by a rise in non‐communicable diseases (e.g., cardio‐vascular disease), rare diseases (RD) are yet to be acknowledged. It is estimated that RD affect approximately one in every 15 South Africans, amounting to a staggering 4 million people in SA that is not acknowledged and supported.

Proposed Solution: As a means to achieve action towards rare diseases in SA, the Centre of Human Metabolomics (CHM) aims to increase scientific and innovative outputs called for by the SA Department of Science and Innovation (DSI), through innovative research utilizing the CHM Biobank as resource. The value of established biobanks in terms of contribution towards biomarker discovery, new diagnostic assay development, new drug development, and clinical trial participation with positive outcomes has been widely proven for high‐income countries (e.g., MetabERN). On the other hand, African RD biobanks offer local genetic diversity and profiles and access to treatment‐naïve patients (and the associated potential for those companies in a position to develop competitive treatments for RD). Orphan drugs represent approximately 40 to 50% of novel drug approvals by the FDA. The benefits of RD research extend far beyond those patients affected by it. The enormous scientific value that RD biobanks have and continue to offer are all too frequently forgotten. RD have the unique ability to unlock some of the complex biomedical answers needed to help advance common disease research.

Conclusions: RD biobank samples find application within the scope of health innovation and improved healthcare, not only for RD, but also for common disorders. RD biobanking advances basic science and may lead to multiple drug discoveries and academic publications, both now and via the use of samples retrospectively as knowledge and technology develop, building a robust, locally relevant evidence base that is able to respond to the ever‐changing landscape of RD

PH‐05 Sunnybrook Hematology Biobank: First‐Year Audit and Quality Assurance Results

A. Misura¹, N. Naveed¹, M. Siddiqui¹, G. Yogendran¹, I. Rashedi¹, E. Salvant¹, d. Chadwick^{1, 2}, S. Chow^{1, 2}, H. Tsui^1,2

¹Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, ²Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

Introduction: Complementing a new acute leukemia referral program, the Sunnybrook Hematology Biobank is a bioresource of living bone marrow and peripheral blood mononuclear cells and plasma collected serially from patients with bone marrow disorders including acute leukemia. This joint venture between hematologists, hematopathologists, and scientists leverages clinical infrastructure to optimize patient recruitment, biospecimen processing, and data annotation. The biobank undertakes to regularly audit and conduct quality assurance analysis of procedures and biobanked samples. We report the interim results of the first year of operations.

Materials and methods: The Research Ethics Board‐approved Hematology Biobank opened in January 2021. For the analysis, we performed an audit to determine the number of participants enrolled as compared to eligible patients. We also analyzed the number, yield, and viability of cryopreserved mononuclear cells isolated by density gradient centrifugation from serial bone marrow aspirate (BMA) and peripheral blood (PB) specimens.

Results: Of 85 patients who met eligibility criteria, 59 participants have enrolled in the Sunnybrook Hematology Biobank this year. Approximately 75% of participants have acute myeloid, acute promyelocytic or acute lymphoblastic leukemia. The remaining 25% of participants were diagnosed with a myeloproliferative neoplasm or other bone marrow disorder. A significant barrier to enrollment was medical emergency at diagnosis such that it was not feasible to review the protocol with eligible patients before urgent BMA or PB collection for clinical purposes.

A total of 1,531 samples of plasma and mononuclear cells have been processed and stored to date including serial samples (2‐4 time points) from close to half of acute leukemia participants. While viability was consistently greater than 90%, the yield of cryopreserved mononuclear cells was highly variable ranging from fewer than 10e6 cells/ml to greater than 10e9 cells/ml from specimens collected during treatment and before treatment, respectively.

Conclusion: This Sunnybrook Hematology Biobank is a key initiative of the Precision Diagnostics and Therapeutic Program at Sunnybrook, facilitating personalized medicine research. The results of the audit will help optimize biospecimen support of high‐priority research on new preventative, diagnostic, and treatment strategies for hematologic disorders including highly aggressive acute leukemia.

PH‐06 Progress in Biobanking with the Cooperative Human Tissue Network (CHTN) Midwestern Division to Enable Pathologist‐Supervised Distribution of High‐Quality Tissues for Basic and Translational Research

R. Mandt, D. G. Nohle, N. Shaker, M. E. Couce, R. Dhir, K. Shilo, L. W. Ayers, A. Parwani

CHTN‐MW Division, Columbus, Ohio, United States

Background: Cooperative Human Tissue Network, Midwestern Division (CHTN MWD), is a National Cancer Institute (NCI)‐sponsored prospective human tissue procurement program that provides human research tissues and approved demographic and clinical data to approved investigators. The objective is to ensure that each NCI‐funded cancer researcher has sufficient, appropriate cancer tissue and data resources to accomplish their stated/funded goals.

Methods: The Department of Pathology Tissue Procurement Service procures remnant tissue from fully consented surgical cases with medically indicated surgery resulting in remnant tissues. Research samples are also collected from consented autopsies. The collection is locally prospective but if MWD is unable to collect the tissues needed over the time requested, or if geographically diverse samples are desired or racial or ethnic samples are requested, the request can be networked to the other members of the CHTN nationally. Data related to the collection, processing, distribution, and transient storage of tissue samples is maintained in CHTN MWD Research Tissue Procurement ‐ Information System (RTP‐IS).

Results: Of the 28,860 tissue samples shipped to investigators during 2016‐20, 16,720 (57.9%) were cancer and 7,607 (26.4%) normal adjacent/distant to the malignant tissue, 1,420 (4.9%) were benign, 3,113 (10.8%) were normal.

Of the 16,575 primary (vs. metastatic) malignant samples shipped by CHTN MWD 2016‐20, adenocarcinoma was the most common cancer diagnosis with 5,448 samples (32.9%), followed by 2,790 (16.8%) carcinoma category that included largely breast and thyroid cancers, 2,312 (13.9%) normal, 1,836 (11.1%) squamous cell carcinoma, 1,260 (7.6%) renal cell carcinoma, 586 (3.5%) melanoma, 290 (1.7%) glioblastoma, 284 (1.7%) leukemia, 264 (1.6%) transitional cell carcinoma, and 187 (1.1%) sarcoma. A total of 1,318 samples with 69 other cancer or tumor diagnoses (representing less than 1%) were distributed.

Conclusions: The availability of a variety of cancer histopathology types custom collected for the investigator with associated minimal demographics represents a significant resource to local and national researchers. All tissue samples are de‐identified, often annotated as per protocols. The CHTN national website (https://www.chtn.org/) is a valuable source of information and a gateway to access the on‐demand repository. Researchers, including pathologists, can create customized protocols, including focus of AI and image analysis research.

PH‐07 Collection and Utilization of Biospecimen after BNT162b2 and ChAdOx1 Vaccination ‐ National Dasman Diabetes Biobank, Dasman, Kuwait

S. Devarajan¹, M. Abufarha², J. Abubaker², H. Ali³, A. Alterki⁴, A. T. Thanaraj⁵, F. Almulla⁵

¹National Dasman Diabetes Biobank, Dasman Diabetes Institute, Dasman, Kuwait, ²Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute, Dasman, Kuwait, ³Department of Medical Laboratory Sciences, Kuwait University, Dasman, Kuwait, ⁴Medical Division, Dasman Diabetes Institute, Dasman, Kuwait, ⁵Department of Genetics and Bioinformatics, Dasman Diabetes Institute, Dasman, Kuwait

Background: Non‐pharmaceutical interventions have been implemented worldwide since the COVID‐19 outbreak started in attempts to slow the pandemic surges, and efforts have been focused on the development of effective COVID‐19 vaccines to curtail the pandemic targeting all population. National Dasman Diabetes Biobank (NDDB) at Dasman Diabetes Institute (DDI) is actively involved in biospecimen and related data collection from vaccinated people who had previous COVID‐19 infections with the response in vaccinated people who had not had COVID‐19 infections in Kuwait. The samples were utilized to compare the antibody‐mediated immune response in terms of SARS‐CoV‐2 S1‐specific IgG, IgA, IgM, and anti‐S RBD neutralizing antibody levels.

Methods: We utilized Research Electronic Data Capture (REDCap) Survey Questionnaire which includes age, gender, height, weight, comorbidities, and symptoms associated with COVID‐19 infections, to recruit the participants for biospecimen collection. The Ethical Review Committee of DDI and Kuwait Ministry of Health reviewed and approved the study. People who received either one or two doses of the BNT162b2 (Pfizer–BioNTech) mRNA vaccine and ChAdOx1 (AstraZeneca) vaccine are eligible to participate it in the study. Blood sample (EDTA tubes) were collected from each participant after obtaining the informed consent. Samples were centrifuged at 400 x g for 10min at normal room temperature to separate the plasma, which was then aliquoted and stored at −80 °C at NDDB.

Results: From April to September 2021, over 4,000 biospecimens have been collected from 1,393 unique participants, consisting of PBMC, plasma, and buffy coat. Over 2,370 biospecimens have been released to approved study teams for various experiments with related data parameters.

Conclusions: This infrastructure and workflow from participants who received vaccines allows our researchers to search specific criteria and obtain samples from our biorepository to achieve their research goals.

PH‐08 Setting up a Fresh Tumor Tissue Biobank From a Single Oncosurgeon's Practice

M. Kulkarni, S. Tamhane, L. Busheri, C. Koppiker

Center for Translational Cancer Research, Prashanti Cancer Care Mission Pune, Pune, MH, India

Statement of the problem: Biorepositories have been created throughout the last decade, adding fundamental research studies from various medical specialties. Fresh frozen biobanks, in particular, are essential assets for translational research. We propose a biobank of fresh frozen tissues from malignant breast diseases generated as an integral part of the diagnostic workup and treatment.

Proposed Solution: Though surgery is considered the primary treatment for breast cancer, additional treatment regimens may involve a combination of other treatments, such as chemotherapy, hormone therapy, targeted therapy, and radiation therapy. Ours is a multidisciplinary unit with various expertise like radiologists, oncologists, and surgeons working under the same practice. Since the biobank will be taken from this single practice, it will represent a cohort that has followed NCCN guidelines and comes from the same Tumor Board. The cohort will be treated with oncoplastic breast surgery where appropriate. Such surgeries yield broad tumor margins, reduction tissue from the same breast, and contralateral breast tissue. This is one of the few units in India to use advanced breast operative techniques routinely. Especially the adjacent and paired normal tissue will be an invaluable asset for translational research.

Conclusions: Here we depict the work in progress to collect frozen breast tissue samples at biopsy and surgery with appropriate ethical approvals and patient consent. Tissue samples will include blood, peritumoral and tumor tissue, ipsilateral nodes, and contralateral breast tissue. The detailed standard operating procedures for consent, tissue collection, preservation method, transport, and storage are depicted here. The workflow is presented here to receive valuable feedback from experts in the biobanking field.

PH‐09 The Implementation of the First DNA Bank for Neurogenetics Research in Peru

D. Cubas‐Montecino¹, C. Manrique‐Enciso¹, K. Milla‐Neyra¹, P. Mazzetti^{1, 2}, M. Cornejo‐Olivas^{1, 3}

¹Neurogenetics DNA Bank and Neurogenetics Research Center, Instituto Nacional de Ciencias Neurológicas, Lima, Peru, Lima, Peru, ²School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru, ³Center for Global Health, Universidad Peruana Cayetano Heredia, Lima, Peru

Background: Biobanks have been recognized as fundamental specialized units providing support for collaborative research studies across the globe. There are very few DNA banks operating in Latin American countries. We aim to describe the implementation of the first DNA bank for research on neurogenetic and related disorders in Peru.

Methods: From October 2020 to January 2022, we aimed to implement the first DNA bank within the national reference specialized healthcare for neurological disorders in Lima, Peru. We propose to accomplish the following steps:

IRB approval of the research proposal for a DNA bank for research on neurogenetics disorders.

Implementation of a new facility supported by international research institutions.

Development of standardized operating procedures.

To provide trained specialists and lab technicians.

Management of DNA samples serving ongoing genetic research projects.

Results: By December 2021, we accomplished the following:

IRB approval with the compromise of monthly reports to the local IRB committee.

Novel facility completed with the opening ceremony performed in May 2021, supported by international research Institutions (LARGE PD, GP2/ASAP, MJFF).

A total of 17 standardized operating procedures for organization, enrollment of participants, storage and custody of DNA samples, management of DNA samples and associated data, and other specific procedures.

Two key personnel including a directing administrator and two lab technicians currently work at the DNA bank; scheduled training is planned for 2022 both locally and internationally.

BADN stored a total of 1,024 samples with associated data. Genomic DNA was extracted using commercial kits based on a silica membrane followed by quality analysis, with two aliquots of DNA stored at ‐20 °C and ‐80 °C, respectively. Related information includes demographics and 3‐generation pedigree brief cognitive assessment. All samples were collected under broad informed consent forms that provide specific authorization from donors for future research use. Current projects providing samples to the DNA bank are related to genetic research on Parkinson's, Alzheimer's, inherited ataxias, among others.

Conclusions: The DNA Bank‐Neurogenetics represents a fundamental milestone for genetics collaborative research in Peru. Current projects using BADN services will move forward genetics research and strengthen collaborative studies on understudied populations.

PH‐10 Who Wins? Benefit Sharing in the H3Africa Biorepository Programme

E. Mayne^{1, 2}, C. Beiswanger^{4, 5}, T. Croxton^{4, 5}, M. Kader⁶, J. Troyer⁷, S. Srinivasan⁸, M. L. Joloba³, A. Abimiku^{4, 5}

¹Pathology, University of Cape Town, Cape Town, Western Cape, South Africa, ²Immunology, National Health Laboratory Service, Johannesburg, Gauteng, South Africa, ³Integrated Biorepository of H3Africa, Makerere University, Kampala, Uganda, ⁴Institute of Human Virology Nigeria, Abuja, Nigeria, ⁵Institute of Human Virology, School of Medicine, University of Maryland, Baltimore, Maryland, United States, ⁶Clinical Laboratory Services, Johannesburg, Gauteng, South Africa, ⁷National Human Genome Research Institutes, National Institutes of Health, Bethesda, Maryland, United States, ⁸Division of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States

Statement of the problem: The National Institutes of Health (NIH) established the Human Heredity and Health (H3) Africa Biorepository Programme in 2014 at three African sites (Nigeria, Uganda, and South Africa) to store genetic material collected by researchers across 27 African countries. Participants from a broad range of ethnic backgrounds provided informed consent for storage and secondary use of material. Although human research ethics committees based at African research institutions approved the utilization of these African samples for potential secondary research, the requirement to demonstrate benefit that will accrue to the research participants or donors of this material, as well as the continent as a whole, is not apparent. We aimed to identify different benefits which may accrue to stakeholders.

Possible solutions

Direct benefit

The interconnectness of individuals in Africa is described as Ubuntu which translates broadly as humanity through others. This pervasive African ideology needs to be understood when interacting with individual African participants, suggesting benefit should be considered at the community level. The H3Africa biorepositories recognized that community engagement was central to maximize individual utility and undertook to enhance social engagement and education and to build a shared understanding of ethical issues associated with biorepositories. We aim to continue to leverage these samples to develop new biotechnologies for African disease diagnosis and treatment and to develop policies on feedback of research findings to benefit the individuals directly.

Research development: Capacity and development of African biobankers is key and we established collaborative and mentorship networks in Africa. This resulted in six publications on biorepositories in Africa, showcasing African biorepository science on the international stage. It has also allowed development of research tools like the first chip to investigate polymorphisms in African populations. Biorepositories in Africa provide access to understudied populations which are key to understanding common diseases in the African diaspora and to understanding emerging diseases of concern. The well‐characterized resources represent an international asset.

Conclusion: It is critical to define benefit as an ethical issue in biorepository science. This concept can be broadly defined and is key to successful engagement with participants and their communities.

PH‐11 Building Blocks for Better Biorepositories in Africa

T. Croxton^{1, 2}, E. Jonathan¹, P. J. Ozumba¹, K. Suleiman¹, S. M. Aloyo³, R. E. Kamulegeya³, M. Kader⁴, G. Swartz⁴, A. Abimiku^{1, 2}, M. L. Joloba³, E. Mayne⁴

¹I‐HAB, Institute of Human Virology Nigeria, Abuja, Nigeria, ²University of Maryland School of Medicine, Institute of Human Virology, Baltimore, Maryland, United States, ³Integrated Biorepository of H3Africa Uganda, Makerere University, Kampala, Kampala, Uganda, ⁴Pathology, University of Cape Town and National Health Laboratory Services, Johannesburg, Johannesburg, South Africa

Background: Biorepositories archive and distribute well‐characterized biospecimens for research to support the development of medical diagnostics and therapeutics. Knowledge of biobanking and associated practices is incomplete in low‐ and middle‐income countries where disease burden is disproportionately high. In 2011, the NIH and Wellcome Trust founded the Human Heredity and Health in Africa (H3Africa) consortium to promote genomic research in Africa and established a network of three biorepositories regionally located in East, West, and Southern Africa to support research. This abstract describes the processes established by H3Africa biorepositories to prepare research sites to collect high‐quality biospecimens for deposit at H3Africa biorepositories.

Methods: The biorepositories harmonized practices between the biorepositories and the research sites.

Drafted guidelines to establish best practices and define biospecimen requirements.

Drafted standard operating procedures (SOPs) for common processes such as biospecimen collection, processing, storage, transportation, and documentation.

Drafted a minimal associated dataset and format.

Developed template data and material agreements to govern biospecimen exchange.

Trained and mentored sites in relevant biobanking processes and procedures.

Piloted ethical and legal procedures and requirements.

Piloted biospecimen deposit process with sites.

Results: The 24 research projects deposited 77,447 high‐quality biospecimens, in accordance with ethical and legal requirements and established best practices. The biorepositories developed human capacity and resources for 20 projects based upon need.

‐ Developed 14 guidelines, SOPs, and documents.

‐ Trained 176 clinicians and scientists in over 30 topics.

‐ Sensitized ethical bodies.

‐ Established MTAs and reviewed consent forms for all projects.

‐ Attained three import permits.

‐ Evaluated pilot and provided feedback: nine shipments and quality control and data for 4,052 biospecimens.

Conclusion: Knowledge of biobanking and its related activities are limited in low‐ and middle‐income countries; however, biorepositories can help build human capacity and resources to support biobanking by partnering with researchers. Partnerships can be structured and customized to incorporate document development, ethics, training, mentorship, and pilots to prepare sites to collect, process, store, and transport biospecimens of high quality for future research.

Informatics & technology

PI‐01 Lessons Learned: Implementation of a Biobanking Informatics Solution for the Research Enterprise

D. Aaronson, N. Gabancho, S. Basnet

Office of Research/CTSI Biospecimen Services Program, University of California San Francisco, San Francisco, California, United States

Background: Biobanking informatics solutions offer the promise of a means to catalog, annotate, and track biological samples, creating a centralized location for data associated with biospecimens. A robust sample management system is integral infrastructure in support of UCSF's vision to fulfill the promise of precision medicine, fostering new discoveries, better outcomes, and greater health equity. System implementation is challenging when bringing on one biobank or research lab and is considerably more complex for an institution with a very large and diversified research enterprise. An implementation of this complexity involves a heterogenous end‐user population, institutional privacy and security reviews, legacy data migration, system integrations, and significant change management efforts.

Methods: A vision for the implementation was presented to UCSF institutional leadership. An open RFP process identified a vendor‐provided solution with a biobanking focus and user‐friendly interface. The implementation team, vendor, and UCSF Procurement developed contract terms and a Statement of Work. UCSF and the vendor created an implementation plan and project charter. Stakeholders were identified representing diverse interests in the implementation and its outcomes.

Results: In August 2021 MBioLIMS BioBanking® Software rolled out to a group that provides biospecimen acquisition, processing, storage, and distribution services to the UCSF research enterprise. Post‐rollout, additional research labs have been brought onto the system with the ability to share study details and biospecimen research data with collaborators across the institution. By leveraging a faculty advisory committee, a collaborative vendor/client partnership, end user feedback, and a continuous improvement mindset, UCSF and Modul‐Bio are well positioned to use the system in alignment with institutional strategic vision and the needs of end users.

Conclusions: Leadership support, strategic vision, funding sources, an experienced implementation team, and a broad set of committed stakeholders are key factors when implementing an enterprise biospecimen informatics solution at an academic institution. The system must be user friendly and manageable for lab technicians and other end users. Time and effort against change management must be committed to. Finally, the vendor/client relationship should focus on trust, collaboration, and a shared understanding of what success looks like for the institution.

PI‐02 Data Sharing Approaches in the Cancer Moonshot Biobank Study

V. Gopalakrishnan¹, A. Mohandas², P. Guan¹, J. McLean², M. Jensen², A. Rao¹, E. Casas‐Silva¹, H. Ellis³, J. Wanyiri², L. Agrawal¹, S. McDermott¹, P. Williams², H. Moore¹

¹Biorepositories and Biospecimens Research Branch, National Cancer Institute, Rockville, Maryland, United States, ²Leidos Biomedical Research Inc, Frederick, Maryland, United States, ³Biobanking Without Borders, Durham, North Carolina, United States

Statement of the problem: In the genomic era, biobanks should not only be repositories for high‐quality biospecimens but also a valuable resource for accompanying well‐annotated, structured data that enable researchers to study complex diseases, develop diagnostics, and improve treatments. Variability in protocol‐specific data requirements, lack of well‐defined data standards, differences in software systems used to collect such data, and limitations in understanding researchers' data needs make it challenging for biobanks to collect and provide standardized data that is useful to a wide range of researchers.

Proposed Solution: NCI's Cancer Moonshot Biobank (CMB) has been set up to collect high‐quality longitudinal biospecimens and comprehensive clinical and biospecimen data from over 1,000 research participants undergoing standard of care cancer treatments. Biospecimens and associated data will be distributed to investigators to accelerate cancer research, better understand drug‐resistance mechanisms, and improve immunotherapy. CMB's study team worked closely with data managers, oncologists, pathologists, bioinformaticians, clinical research associates, and NCI grantees to determine data needs for the study. Medidata Rave is used as the clinical data management system to collect structured clinical and biospecimen data; a biorepository LIMS records detailed biospecimen processing and inventory data. This clinical and biospecimen data are transformed and stored in an in‐house data management environment, and will be made available to researchers through the NIH Database of Genotypes and Phenotypes (dbGaP) and NCI Clinical Trials Data Commons. TRIAD (Transfer of Imaging and Data), a cloud‐based image and data exchange platform, is used to collect the study's radiological and histological images which will be made available through The Cancer Imaging Archive. An online catalog will display an inventory of available biospecimens to researchers. Data in these different platforms will be linked so that researchers are able to navigate across these platforms to retrieve relevant data associated with the biospecimens to inform their analyses.

Conclusion: The Cancer Moonshot Biobank's data available through NCI's data sharing platforms is envisioned to provide researchers the power of well‐annotated structured data so that they are able to better understand drug resistance mechanisms and improve immunotherapy to treat cancer.

PI‐03 The Cancer Moonshot Biobank Online Catalog

P. Guan¹, H. Ellis², V. Gopalakrishnan¹, J. McLean³, M. Jensen³, A. Mohandas³, S. McDermott³, L. Carroll⁴, S. Brennan⁴, K. Taylor⁴, E. Casas‐Silva¹, L. Agrawal¹, A. Rao¹, J. Wanyiri³, P. Williams³, H. Moore¹

¹National Cancer Institute, Bethesda, Maryland, United States, ²Biobanking Without Borders LLC, Durham, North Carolina, United States, ³Leidos Biomedical Research, Inc, Frederick, Maryland, United States, ⁴Information Management Services Inc., Calverton, Maryland, United States

Statement of problem: The National Cancer Institute's (NCI) Cancer Moonshot Biobank (Biobank) collects longitudinal biospecimens and associated clinical data from research participants with advanced cancer. The Biobank partners with community hospitals across the U.S. that are part of the NCI Community Oncology Research Program (NCORP) to engage a diverse patient cohort who are receiving standard of care therapy. Biospecimens will be distributed to approved researchers focusing on cancer drug resistance and sensitivity research, for which longitudinal samples are a critically missing resource. The Biobank is developing an online system to facilitate researchers' access to the Biobank inventory and manage sample requests.

Proposed Solution: To provide transparency and facilitate access to this unique resource, a web‐based catalog is being built as a searchable, online database of Biobank biospecimens and associated data. The Cancer Moonshot Biobank Catalog builds upon investments in similar work that has been undertaken by other Institutes at the National Institutes of Health. The website will provide public information about the Moonshot Biobank including its mission, biospecimen types, access policies, and procedures. Researchers will be able to create a password‐protected account in the system to have private communication with the Biobank administrator; search the Biobank inventory based on biospecimen requirements and a limited set of de‐identified clinical data; and make online sample requests. An access committee will evaluate requests using evaluation criteria outlined in posted access policies. To help maintain the Biobank's sustainability, the Biobank will charge nominal fees to cover biospecimen retrieval, processing, and shipping costs; billing and payments will be managed within the system. Once a researcher's request is approved and biospecimen availability is verified, the requested biospecimens will be shipped to the researcher.

Conclusion: Given the longitudinal nature of the Biobank, and its aim to facilitate research that requires sequential biospecimens, biospecimens will be released for research access when significant sets of longitudinal samples have been collected. When this online catalog opens to the public, it will become another important platform connecting the research community with the Moonshot Biobank. Additional resources will include clinical, analytical, and imaging data that will be available from other public repositories.

PI‐04 The Intelligent Application for Clinical and Molecular Classification of Oral and Maxillofacial Cancers

Z. Zhang^{1, 2}, Q. Xu^{1, 2}, Z. Li^{1, 2}, X. Pan^{1, 2}, W. Chen^{1, 2}

Oral maxillofacial cancer is a serious risk to the human health world widely. Its tumorigenesis and development are consistent and multi‐processes events, and it is widely recognized as one of the optimal disease models for molecular classification by precise medicine. To break through the bottleneck limited by the traditional research strategies, the “Sharing platform for the tissue sample and bioinformatics database of oral maxillofacial tumor” has implicated intelligent methods to accelerate the fundamental research and clinical application processes on molecular classification of oral maxillofacial cancers. Owing to the well‐preserved specimen and fully recorded information, the platform was able to conduct the transformation from clinical samples to omics data of various dimensions, including massive scale data from genetics, epigenetics, metagenomics, histopathology, and radiomics. Therefore, artificial intelligent methods as deep learning and neural network were performed to rearranging the large datasets and produce diagnostics models for clinical and research usage. Through the platform, researchers and clinicians get access to the data of mutations, abnormal transcription, modifications on RNA or proteins, and information normalized from IHC or other clinical images of oral maxillofacial cancers. A series of models are provided to valuate cancer‐related studies as discovering biomarkers, validating treatment target, designing transforming researches, etc.

This work was supported by the National Program on Key Research Project of China (2016YFC0902700), Shanghai Municipal Science and Technology Commission Funded Project (18DZ2291500) and SJTU Trans‐med Awards Research (WF540162615). * E‐mail: chenwantao2002@hotmail.com, 86(21)63135412

PI‐05 Using Artificial Intelligence for Samples Quality Control in Biobank

S. Gramatiuk^{1, 2}, Y. Ivanova^{1, 3}, V. Boyko^{3, 1}

¹Ukraine Association of Biobank, Kharkiv, Ukraine, ²Department of Comparative Biomedical Sciences, Louisiana State University, Baton Rouge, Louisiana, United States, ³Institue of General and Urgent Surgery, Kharkiv, Ukraine

The accelerated market hype around artificial intelligence (AI) has made it a buzzword of almost every industry. Businesses, irrespective of their industry, are interested to invest in the potential of AI to automate, assist, and augment various value‐based tasks.

This study used AI‐based model predict cell line viability using images captured by optical light microscopy.

We focused this study on a new and complementary CQ approach to cell line and stem cell line intelligence in biobank.

Using Louisiana State University's DeepDrugTM Artificial Intelligence Computing, we have combined computer vision image‐processing methods and deep‐learning techniques to create the non‐invasive Life Cell AI UAB model for robust prediction of cell line viability, using single static images obtained from standard optical light microscope systems.

The Life Cell AI UAB model showed a sensitivity of 82.1% for viable cell line while maintaining a specificity of 67.5% for non‐viable cell line across three independent blind test sets from different biotechnology laboratories. The weighted overall accuracy in each blind test set was >63%, with a combined accuracy of 64.3% across both viable and non‐viable cell lines, demonstrating model robustness and generalizability beyond the result expected from chance. Distributions of predictions showed clear separation of correctly and incorrectly classified cell lines. Binary comparison of viable/non‐viable embryo classification demonstrated an improvement of 21.9% over cell lines accuracy (P = 0.042, n = 2, Student's t test), and standard operating procedure of QC comparison demonstrated an improvement of 42.0% over embryologists (P = 0.026, n = 2, Student's t test).

The superior accuracy of the Life Cell AI UAB model could lead to improved quality control assessments of samples in biobank. It could also potentially assist in standardization of QC methods of cell line and stem cell across multiple environments, while eliminating the need for complex time‐lapse imaging equipment.

Repository management

PJ‐01 Setting Up for Success: Preplanning Repository Meta‐data Collection for Operational Sustainability

M. K. Henderson¹, T. M. Johnson³, J. Kessler²

¹DCEG and CGH, National Cancer Institute, Rockville, Maryland, United States, ²Independent Consultant, Cincinnati, Ohio, United States, ³DCTD, NCI, Rockville, Maryland, United States

Statement of problem: Often, as biorepositories are set up to be operational, there is much focus on the financial and physical aspects, but not as much attention to the collection of data supporting repository management. Data about the biorepository itself and its planned potential collections are needed for day‐to‐day operations. This includes how to advertise and share materials, establishing governance, degree of emergency preparedness, as well as sustainability (socially, operationally, and financially). All these data are elements of the repository useful for determining sample value and maintaining collections relevant for advancing research.

Proposed Solution: This presentation will examine common meta‐data categories that should be collected and reviewed in support of repository operations, planning/managing de novo and donated sample collections. Data from these categories are easier to collect if planned prior to initiation of collection and ethical review vs. later attempts to capture in a harmonized format.

Conclusion: Early understanding of the types of meta‐data needed to successfully manage operations to increase sample/collection value and usage will ultimately support a repository's overall sustainability.

PJ‐02 An Experience of Organizing the First National Tumour Tissue Repository (NTTR) in India

S. Desai, M. B. Kulkarni, A. Deshpande, L. Choughule, S. Bhatte, A. Patil, S. Menon, R. Badwe

Tata Memorial Centre, Mumbai, Maharashtra, India

Background: NTTR was established in the year 2005 to bank all types of diseased as well as normal tissues and components of blood and distribute the biospecimens to researchers. Standardized methods are used for collection, long‐term storage, retrieval, and disbursement for retrospective as well as prospective research initiatives. Clinical information and follow‐up records of all patients whose biospecimens are maintained in the biorepository are provided to investigators, whenever required while protecting the confidentiality of data and privacy of specimen donors.

Methods: The process of organizing NTTR was classified into various tasks viz. operational/technical, administrative, and ethical/legal aspects. Standard operating procedures were established for the collection, storage, retrieval, disbursement, and quality control. The biospecimens are collected following an administration of broad informed consent. The indigenously developed software is being used to anonymize the biospecimens and facilitate the storage and retrieval of biospecimens. An online biobank form is developed on the intranet to collate clinical and follow‐up data. Disbursement of tissues is done for institutional review board‐approved projects through NTTR Technical Authorization Committee. A material transfer agreement is sought for disbursement of biospecimens to non‐institutional investigators.

Results: During the period of 16 years from May 2005 to June 2021, a total of 63,817 tissues were collected from various anatomic sites from 42,651 patients following administration of informed consent, and 9,328 biospecimens were disbursed to investigators for various institutional review board‐approved projects. Clinical information was provided as per the investigators' requirements. A total of 21 peer‐reviewed publications have acknowledged valuable contributions by NTTR in translational research.

Conclusions: Central tissue repository has many advantages like efficient control of biospecimens, easy availability of various types of tissues, and an increased opportunity to participate in intramural and extramural research. A repository can be easily implemented in a pathology laboratory. High‐quality and well‐annotated ethically procured biological samples are valuable institutional resources for basic and translational research.

PJ‐03 Beyond Sustainability: Keeping Paediatric Biobanking Relevant.

L. Zhou, D. R. Catchpoole

Children's Cancer Research Unit, Kids Research, The Children's Hospital at Westmead, SCHN, Westmead, New South Wales, Australia

Pediatric biobanks are key resources for translational research of childhood diseases which are crucial for future healthcare improvement for children. Development of personalized medicine for children relies on translational research using their biospecimens. Due to the rarity of childhood diseases, small specimen volumes, limited population of children, and relative smaller scale of pediatric research, the sustained activity for many pediatric biobanks is vital for their effectiveness. When considering how pediatric biobanks can maintain effective activity over an extended time, a key but unrecognized element for sustainable biobanking is maintaining the biobanks' relevance, a quality that is linked to the benefit brought by the biobanking practice. Specifically this requires a balance of consistency in operations with a flexibility to adjust to the changing needs of the research ecosystem as it develops. The primary goal of this presentation is to offer perspectives from a single institutional pediatric biobank embedded within a hospital and the advantage in providing biobank activities as part of clinical care, leading to the continued relevance of a bio‐resource for pediatric cancer research. In light of this, we review the activity of The Tumour Bank at The Children's Hospital at Westmead which, over 20 years, has demonstrated a consistently successful and sustainable pediatric biobanking model. Relevance of this pediatric biobank was demonstrated through its model of embedded operations, consistent research productivity, currency of tissue handling expertise, defined and accepted practices, as well as it ongoing engagement of patients.

PJ‐04 What Does This Mean? My Data is Invalid... The Need for Data Standardization

K. Peterman

Life Sciences, Merrick & Company, Manassas, Virginia, United States

Background: Repository management of biological materials also means repository management of the data associated with those materials. Early on repositories set up Excel spreadsheets, Access databases, or created in house versions of databases to management the repository's data. With the new databases that are now available for repository data management, a new set of problems are presenting themselves which requires additional planning and input from the users of the database so that data can be imported from an existing data capture tool, or a new sustainable database can be established.

Method: The following problems will be evaluated on how they can be addressed during the planning phases for a new database.

These problems fall into the following categories:

Data that are not standardized.

Misused or undefined data fields.

Freeform “catch all” or comment fields.

Links to external files.

Database unique identifiers and labeling.

Results and Conclusions: Establishing criteria in all these areas prior to the selection of a database software and then working with stakeholders to address each area for configuration of a new database will alleviate most issues with data migration. There will still need to be data “cleanup” prior to any data migration, but understanding your data, the end criteria for the data, and communicating this with your stakeholders and the database integrator can make for a smoother transition.

PJ‐05 Development of a Combined Query Tool to Capture Comprehensive Biorepository and Cancer Registry information at an Academic Medical Center

R. Singh¹, P. McShane¹, N. Garcia¹, T. Delao¹, R. Ibrahim¹, D. Price¹, D. Bernard²

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

Background: The Cancer Center at Houston Methodist Hospital System is preparing for NCI‐designated comprehensive cancer center status. A query tool is being designed where the Cancer Center PIs and other institutional cancer researchers can access and query HMRI Biorepository's inventory independently. Integrating biospecimen‐related data from the Cancer Registry via the Biorepository Information Management System was proving to be a challenge. It was decided to develop an independent query tool where the biospecimen data and related basic information from the Biorepository Information Management System could be merged with the cancer‐related clinical information from the Cancer Registry database. The Office of Academic Technology and Informatics Services, Houston Methodist Academic Institute, working with Houston Methodist Research Institute Biorepository and the Cancer Registry, Houston Methodist Cancer Center, has been able to develop a unique query tool where PIs can access both or either biorepository/biospecimen‐related information and/or the cancer registry information on the biospecimens and individual patients.

Methods: A project with the Office of Academic Technology and Informatics Services, Biorepository, and Cancer Registry staff on board was initiated in January 2021. Project scope and timeline was defined. Cancer Center Director and other PIs were consulted to define the cancer registry data elements which would form part of this query tool. The biospecimen‐related data elements to be ported from the Biorepository Information Management System to the query tool were also defined. The Office of Academic Technology and Informatics Services staff were assigned the task of designing and developing the query tool based on different biospecimen‐related data elements as well as type of biospecimen collection. The necessary Cancer Registry data elements are integrated to each individual biospecimen. Additionally, Cancer Registry data for patients with non‐availability of biospecimens can also be queried separately.

Results: The initial iteration of the query tool was presented to the Institutional Executives in September 2021 and was very well received. Final version and beta testing of the tool is soon being planned.

Conclusion: An in‐house, unique query tool encompassing information from both the Biorepository and Cancer Registry has been designed at Houston Methodist and may have widespread applications across the biobanking community.

PJ‐06 The Impact of COVID‐19 on Institute of Human Virology Nigeria, H3A Biorepository (I‐HAB) Services

P. J. Ozumba¹, A. A. Abbas¹, E. Onyemata¹, E. Okpokoro¹, E. Jonathan¹, O. Balogun¹, T. Croxton^{1, 3}, K. Suleiman¹, C. Beiswanger², A. Abimiku^{1, 3}

¹Institute of Human Virology Nigeria, Abuja, Federal Capital Territory, Nigeria, ²Independent Biorepository Consultant, Jersey City, New Jersey, United States, ³Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, United States

Background: The COVID‐19 pandemic exposed unique challenges and opportunities to public health infrastructures including global biobanking. Evaluating this impact will prepare biobanks for future pandemics. We report here the impact of the COVID‐19 outbreak on Institute of Human Virology H3Africa biorepository (I‐HAB) and associated challenges and opportunities.

Methods: We applied SWOT analysis as the framework to identify the strengths, weakness, opportunities, and threats or challenges to biorepository function during the COVID‐19 pandemic.

Results: The SWOT analysis showed the following: Strengths: I‐HAB used its resources to provide support to the national response to the COVID‐19 pandemic. Weaknesses: The nationwide shutdown of facilities to curb epidemic spread, coupled with sick staff and staggered and remote work schedules, resulted in a shortage of manpower and product. Opportunities: COVID‐19 created opportunities for research collaboration and expanded its business: I‐HAB participated in a national COVID‐19 sero‐survey, supported COVID‐19 clinical trials, provided storage for 3,000+ clinical trial drugs, processed and shipped over 2,000 sample aliquots, and participated in the validation of 16 COVID‐19 rapid diagnostics test kits. Threats: Logistics challenges and increased cost hampered procurement of equipment and supplies for I‐HAB services.

Conclusion: Despite routine biorepository services being impeded by the COVID‐19 pandemic, it created unique opportunities for new collaborations and funding and the adoption of IT‐based solutions. Furthermore, it demonstrated the critical role for biorepositories in response to disease outbreaks. Hence, funding opportunities for biorepositories should be prioritized during pandemics.

PJ‐07 Data Validation to Enforce High‐Quality Data

D. Villanueva, W. Ng

Victorian Cancer Biobank, Melbourne, Victoria, Australia

Statement of the problem: In the era of big data analysis, the quality of the associated clinical data is equally as important as the biospecimens for medical research. There are, however, many stages throughout the data lifecycle where data may be handled poorly. While automated data collection or data linkage are the ideal solution for obtaining high‐quality data, manual data entry is still inevitable. Since manual data entry is error prone, measures should be introduced to reduce error entry. This can be achieved by establishing data entry controls, enforcing data entry rules that prevent invalid or inaccurate data from entering the system.

Proposed Solution: At the Victorian Cancer Biobank (VCB), we utilize OpenSpecimen, a biobanking data management system for all our biobanking needs, including annotating and managing the clinical data. The system encompasses a Data Validation (Edit Checks) plugin, which provides the customization of JSON language to set varying levels of constraints for each data field. This allows us to systematically enforce data entry rules that define acceptable and unacceptable values, directly embedded within our business processes. The entered data will not be accepted until the rules are complied. The system will also capture the entries that triggered the rules. Such data can be analyzed through root cause analysis to identify the underlying factors contributing to these errors for future training and quality improvement purposes.

As an example, we have created a data entry rule that checks that the Clinical Status field and Diagnosis code field correlate correctly. So, when the Diagnosis code is ending with either /0 for benign tumors or /2 for carcinoma in situ, Clinical Status should be entered as “Non‐malignant.”

Conclusions: Every biobank should achieve collection of high‐quality data through quality assurance tools to support research in mining information that can provide valuable insights for improving disease outcomes. Edit Checks is a tool that can be used to reduce errors introduced by manual data handling. Collected data that are of high quality can be transformed into reliable and trustworthy information, leading to actionable insights. Insights derived from high‐ quality data can be relied upon by researchers to improve cancer outcomes. By the same token, high‐quality data can also be used by stakeholders to determine business direction and inform funders and policymakers.

Repository standards

PK‐01 Leveraging the Power of a Biobank Quality Management System to Drive Operational Efficiency

S. Ding, S. Paul, A. L. Bolanos, H. Wagner, N. Fleshner

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

UHN Biospecimen Services, encompasses three different biobanks, McCain GU BioBank, Princess Margaret Cancer Biobank, and the UHN COVID‐19 Biobank. To maintain the scientific edge of a rapidly growing sample repository, a robust quality management system (QMS), which encompasses all aspects of a biorepository such as clinic, sample handling and processing, cryostorage, associated data, and staff training, was implemented to the program.

UHN Biospecimen Services uses a Biospecimen Information Management System (BIMS) to:

Document pre‐analytical variables.

Record sample metrics.

Track sample discrepancies using standard comments.

In addition to BIMS, daily collection trackers are maintained for cross‐validation of sample details. Furthermore, monthly sample reconciliation for study‐directed banking and quality assurance (QA) checks are conducted prior to sample release. Periodical QA reviews are conducted on clinical data and sample collection protocols, as well as sample quality control (QC) analysis on banked specimens using unbiased external parties. Any deviation or incidents that occur are reported to our Biobank QA committee. Finally, an external sample release committee validates the ethical and scientific validity of studies requesting access to our repository.

Through implementation of our QMS, UHN Biospecimen Services has banked over 1,200,000 samples and supported nearly 200 projects globally. We bank for several disease cohorts such as GU, GYN, GI, THOR, and COVID‐19. By utilizing a BIMS to keep detailed sample annotations, we maintain our rapidly expanding inventory of biospecimens. Additionally, proper documentation and cross‐validation of sample details allows us to retrieve and distribute samples that suit the needs of research groups. Conducting QC analyses of biospecimens and clinical data helps us determine the effect of pre‐analytical variables on sample quality, integrity, as well as the fitness in translational research.

A robust QMS should be extended beyond sample quality verification and can be implemented to improve Biobank workflow and staff education. A cohesive and vigorous QMS allows consistent control of major processes and workflows, improved risk mitigation and management, as well as better regulation of successful working practices and training to enhance the Biobank's overall operation, quality, and results.

PK‐02 Quality Appraisal in a National Tumor Tissue Repository (TTR) – An Indian Experience

M. B. Kulkarni, N. Karnik, A. Arora, L. Choughule, S. Bhatte, O. Shetty, S. Menon, S. Desai

Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India

Background: This study sought to assess the nucleic acid quality in stored fresh frozen biospecimens and its potential for use in research.

Methods: Quality control exercise was performed every six months on a set of different types of tissues stored in the TTR over a period of 15 years. Tumor tissues snap‐frozen in liquid nitrogen were taken up for DNA and RNA (n = 88) extraction, similarly for tissues stored in RNAlater, RNA stabilizing agent (n = 22), and normal mucosa (n = 2). DNA and RNA were extracted using QIAmp mini kit (Qiagen, Germany). Nucleic acid concentration and purity were checked using NanoDropTM 8000 (Thermo Fisher Scientific, USA) and optical density (OD) ratio at 260/280 nm. Polymerase chain reaction for housekeeping ACTNB gene was performed and electrophoretic integrity at 323bp and 432bp was checked on agarose gel electrophoresis. The parameters were assessed for variation with storage time and type of tumor. Categorical variables were assessed using Fisher's exact T test with p < 0.05 as significant.

Results: All the samples showed optimal DNA concentration (>10ng/μl); however, 5.7% showed low (<10ng/μl) RNA concentration. OD ratio was scored as excellent (1.8‐2.1) in 84.1% and 79.5% and good (1.6‐1.8) in additional 5.7% and 3.4% of extracted DNA and RNA, respectively. Abnormal OD ratio (<1.6 or >2.1) was associated with low RNA concentration (p = 0.03). Gel electrophoresis showed amplifiable bands at 323bp for all samples. However, amplifiable bands were seen in 95.4 % of DNA samples and 92% of cDNA obtained from RNA for 432bp. RNA concentration was maintained in tissues stored in RNAlater in 90.9% cases (20/22) with 260/280 OD being optimal in 72.7% cases and all but one showed an amplifiable band at 432bp. The quality parameters did not show significant change with the type of tumor or duration of storage.

Conclusions: Molecular quality control program ensures the goal of optimizing tissues for translational research and should be an integral part of the quality management system of a biorepository.

PK‐03 Understanding Corrective Actions, Nonconformities, and Root Cause Analysis in ISO 208387:2018

C. D. Arant

Life Sciences, A2LA, Frederick, Maryland, United States

What happens when a known spiked positive comes up negative? What steps are taken when an incorrect material is sent to your largest customer? If the power went out over the weekend and a freezer full of tissue fell out of range for an hour, do you have a process in place to address and correct the error?

ISO 20387:2018 clauses 7.11 and 8.7, nonconforming work and corrective actions, address how to answer these questions. Defined in ISO 9000:2005, clause 3.6.2, a nonconformity is defined as “non‐fulfillment of a requirement.” It is understood that equipment goes out of specification, humans make mistakes, and the best‐laid plans will fail – especially in biobanking when a thunderstorm can knock out power. When those situations arise, an accredited biobank is required to follow a procedure to address the issue. Both nonconformances and corrective actions require determining why the nonconformity happened. Which is often done by performing a root cause analysis. Once the why of a situation is known, the Biobank can take steps to minimize the risk of a similar issue occurring in the future.

This presentation aims to discuss the importance of addressing nonconforming work, examples of methods to conduct a root cause analysis, and that the corrective actions taken are in proportion to the effect of the nonconformity encountered.

The International Society for Biological and Environmental Repositories Presents Abstracts from Its Annual Meeting “Biobanking: Shaping the Scientific Journey” In‐Person: May 17 – 20,2022 Atlanta,Georgia,USA Virtual: June 14 – 15,2022

Abstract

Oral Abstract

O‐01 Biobank Network for Promotion of Utilization of Biobank Toward Realization of Genomic Medicine in Japan

O‐02 Improving Efficiency of Blood Procurement with a Real‐Time Approach

O‐03 Linking the Stability of Clinical Proteins in Blood Plasma to ΔS‐Cys‐Albumin—a Marker of Plasma Exposure to Thawed Conditions

O‐06 Strategies for Generating the Highest Quality Isogenic iPSC Lines

O‐07 NCI's Cancer Moonshot Biobank: Supporting Diversity Through Local Patient Engagement

O‐09 Biobanking: Strengthening Uganda's Rapid Response to COVID‐19 and Other Epidemics

O‐10 How Artificial Intelligence Techniques Can Be Employed to Increase the Success Rate for Identifying Datamatrix Barcodes

O‐11 Data Mining Pathology Reports for Crucial Biomarkers for Samples Held in a Biobank

O‐12 The Utility of College of American Pathologists (CAP) Biospecimen Accreditation for Oncology‐Based Research Pathology at Memorial Sloan Kettering Cancer Center: Lessons Learned and the Path Forward

OPA‐04

OPF‐02

OPE‐02 Integrating Biospecimen Science Approaches into Clinical Assay Development: A National Cancer Institute (NCI) Funding Opportunity for Tissue and Liquid Biopsies (PAR‐22‐049)

Innovative Technology Session

IT‐01 Novel Dry Storage Approach for DNA Preservation at Room Temperature

IT‐02 SARS‐CoV‐2 Sequencing, Polygenic Risk Scores, and Precision Medicine: High‐throughput Solutions

IT‐03 Storage Temperature Monitoring: It Is Not One Size Fits All

IT‐04 Use Case Perspectives: Connecting the Two‐decade Gap in Biobanking Data Management, from Hardware Core Functionalities to Implementation of Novel IT Solutions in Current Biobanking Operational Systems.

IT‐05 Biospecimen Matchmaking: The Data‐Driven Journey from Internal Spreadsheets to Online Inventories to Just‐in‐Time Biobanking

IT‐06 Introducing an Advanced Sample Management System to a Clinical Biobank for the Collection and Storage of Human Colorectal Cancer Clinical Samples

Poster Session

Biobank Tools

PA‐01 Participation in Proficiency Testing Program is Associated with Improvement of Biobank Laboratory Performance

PA‐02 Social Implementation of BiTA, A Qualifying Examination to Evaluate the Competence of Biorepository Personnel

PA‐04 Updates to the Ethical, Legal, and Policy Best Practices of the NCI Best Practices for Biospecimen Resources

PA‐05 The Mathison Centre Neurogenetics Biobank and Advancing in Precision Mental Health

PA‐06 Listening to the Voice of the User to Inform the Next Edition of ISBER's Best Practices: Recommendation for Repositories

PA‐07 Development of the Next Edition of ISBER Best Practices for Repositories

PA‐08 Mapping A Sunburnt Country: An Australian National Biospecimen Locator

PA‐09 Teaching Tissue Microarray Technology and its Applications as a Quality Control Tool in Research and Diagnostics

PA‐10 Quality Assurance/Quality Control (QA/QC) Activities of the NIST Biorepository

PO‐04 Implementation Model of Quality Control Procedures of Fresh Frozen and FFPE Tissue Samples Along with Proficiency Testing Program for Biobanks

Biobanking profiles

PB‐01 Study of Laboratory Staff Knowledge of Biobanking in Côte d'Ivoire

PB‐02 Building a Cancer Biobank in a Low‐Resource Setting in Northern Iran: the Golestan Cancer Biobank

PB‐03 UMMC Biobank: Biobanking For Collaborative Research

PB‐04 Singapore Translational Cancer Consortium

PB‐05 The Neurodegenerative Disease Biobank at Macquarie University, Sydney, Australia

PB‐06 ARICE: Twinning for the Armenian Research Infrastructure on Cancer Research

PB‐07 The NIGMS Human Genetic Cell Repository: A Biomedical Research Resource

PB‐08 The Management of Oral and Maxillofacial Cancer Biobank and Its Access

Biobanking structures

PC‐01 Establishing a Cross Border Network of Biobanks in Central Europe

PC‐02 Supporting Diagnostic Research and Development with Equitable Sample Access and Sharing: Enhancing a Conventional Biobank with the Addition of FIND Integrated Biobanks (FIB) and DxConnect Virtual Biobank

PC‐03 Enhancing the Response to Emerging Infectious Diseases: A Biobank Feasibility Study in the Philippines

Biodiversity/environmental/animal repositories

PD‐01 Development of Conservation Techniques for Liver Samples from Rodents of the Genus Rattus in Abidjan

Biospecimen research, science, and outputs

PE‐01 Induced Pluripotent Stem Cells – The Next Step in the Modelling of Genetic Diseases

PE‐02

PE‐03 SMART Tube Whole Blood Biobanking for Downstream Flow Cytometry

PE‐04 Optimization of Ambient Temperature Storage of Nucleic Acids

PE‐05 A Prospective Breast Cancer Biobank from Single Institutional Cohort

PE‐06 Persistent Organic Pollutants in Bristol Bay Beluga Whales, Delphinapterus leucas

PE‐07 Complementary High‐Throughput RNA Extraction Conducive to Multi‐Omic Characterization of Pediatric Central Nervous System Tumors

PO‐05 Transient Warming Events Impact Ice Recrystallization in RCCs Cryopreserved Using the High and Low Glycerol Freezing Methods

Ethical, legal, and social issues

PF‐01 Effects of Introduced and Cold‐Call on Participation Rates for Biobanking

PF‐02 Informed Consent Models in Biobanking: Results from a Systematic Review

PF‐03 Willingness to Donate and to Receive Results: Should We Return to Donors with Research Findings?

PF‐06 Enhanced Lay Involvement for Improved Biobanking

PF‐07 Improvement of SingHealth Tissue Repository (STR) Broad Consent Form

Hot topics

PG‐01 Keeping an Eye on COVID: CONSERVE Seroprevalence Study For Healthcare Workers For Antibody Testing Over A One Year Period

PG‐03 Overcoming Natural and Socio‐economic Challenges in Biobanking: Examples from USA and Nigeria

PG‐04 Investigation into the Effects of CO2 on Quality of SARS‐CoV‐2 Clinical Specimens

Human specimen repositories

PH‐01 Biobank‐driven Approach to Precision Medicine for the Underrepresented African Population

PH‐02 The Cooperative Human Tissue Network (CHTN) Midwestern Division Uses Whole Slide Images (WSIs) for Pathologist QC Review of Each Distributed Tissue for Lesion Type and % Tumor.

PH‐03 The PROCURE Biobank: A Precious Tool for Prostate Cancer Research

PH‐04 Call for Action Towards Rare Diseases and Associated Health Innovation in South Africa

PH‐05 Sunnybrook Hematology Biobank: First‐Year Audit and Quality Assurance Results

PH‐06 Progress in Biobanking with the Cooperative Human Tissue Network (CHTN) Midwestern Division to Enable Pathologist‐Supervised Distribution of High‐Quality Tissues for Basic and Translational Research

PH‐07 Collection and Utilization of Biospecimen after BNT162b2 and ChAdOx1 Vaccination ‐ National Dasman Diabetes Biobank, Dasman, Kuwait

PH‐08 Setting up a Fresh Tumor Tissue Biobank From a Single Oncosurgeon's Practice

PH‐09 The Implementation of the First DNA Bank for Neurogenetics Research in Peru

PH‐10 Who Wins? Benefit Sharing in the H3Africa Biorepository Programme

PH‐11 Building Blocks for Better Biorepositories in Africa