Biopreservation and BiobankingVol. 21, No. 2 ISBER CornerIt's a Small World After All…or Is It?Clare M. Allocca, Elne Conradie, Koh Furuta, Diane McGarvey, and Alison Parry-JonesClare M. AlloccaAllocca, National Institute of Technology, Gaithersburg, Maryland, USA.Search for more papers by this author, Elne ConradieCentre for Human Metabolomics, North-West University, Potchefstroom Campus, Potchefstroom, South Africa.Search for more papers by this author, Koh FurutaChiba Medical Center, Chiba, Japan.Search for more papers by this author, Diane McGarveyCooperative Human Tissue Network, University of Pennsylvania, Philadelphia, Pennsylvania, USA.Search for more papers by this author, and Alison Parry-JonesWales Cancer Biobank, Cardiff University School of Medicine, Cardiff, South Glamorgan, United Kingdom.Search for more papers by this authorPublished Online:17 Apr 2023https://doi.org/10.1089/bio.2023.29120.cmaAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"It's a Small World After All…or Is It?." Biopreservation and Biobanking, 21(2), pp. 219–220FiguresReferencesRelatedDetails Volume 21Issue 2Apr 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Clare M. Allocca, Elne Conradie, Koh Furuta, Diane McGarvey, and Alison Parry-Jones.It's a Small World After All…or Is It?.Biopreservation and Biobanking.Apr 2023.219-220.http://doi.org/10.1089/bio.2023.29120.cmaPublished in Volume: 21 Issue 2: April 17, 2023PDF download

Open and practical exchange, dissemination, and reuse of specimens and data have become a fundamental requirement for life sciences research. The quality of the data obtained and thus the findings and knowledge derived is thus significantly influenced by the quality of the samples, the experimental methods, and the data analysis. Therefore, a comprehensive and precise documentation of the pre-analytical conditions, the analytical procedures, and the data processing are essential to be able to assess the validity of the research results. With the increasing importance of the exchange, reuse, and sharing of data and samples, procedures are required that enable cross-organizational documentation, traceability, and non-repudiation. At present, this information on the provenance of samples and data is mostly either sparse, incomplete, or incoherent. Since there is no uniform framework, this information is usually only provided within the organization and not interoperably. At the same time, the collection and sharing of biological and environmental specimens increasingly require definition and documentation of benefit sharing and compliance to regulatory requirements rather than consideration of pure scientific needs. In this publication, we present an ongoing standardization effort to provide trustworthy machine-actionable documentation of the data lineage and specimens. We would like to invite experts from the biotechnology and biomedical fields to further contribute to the standard.

Biopreservation and BiobankingVol. 21, No. 3 Original ArticlesThe ISBER 2023 AwardsPiper Mullins, Clare M. Allocca, and Dayong GaoPiper MullinsAddress correspondence to: Piper Mullins, MIS, Pan-Smithsonian Cryo-Initiative, Smithsonian Institution, 3001 Connecticut Ave., NW, Washington, DC 20008, USA E-mail Address: [email protected]Pan-Smithsonian Cryo-Initiative, Smithsonian Institution, Washington, District of Columbia, USA.Search for more papers by this author, Clare M. AlloccaNational Institute of Standards and Technology, Gaithersburg, Maryland, USA.Search for more papers by this author, and Dayong GaoCenter for Cryo-Biomedical Engineering and Artificial Organs, Department of Mechanical Engineering, Department of Bioengineering, University of Washington, Seattle, Washington, USA.Search for more papers by this authorPublished Online:19 Jun 2023https://doi.org/10.1089/bio.2023.29122.pjmAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail View article"The ISBER 2023 Awards." Biopreservation and Biobanking, 21(3), pp. 313–314FiguresReferencesRelatedDetails Volume 21Issue 3Jun 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Piper Mullins, Clare M. Allocca, and Dayong Gao.The ISBER 2023 Awards.Biopreservation and Biobanking.Jun 2023.313-314.http://doi.org/10.1089/bio.2023.29122.pjmPublished in Volume: 21 Issue 3: June 19, 2023Online Ahead of Print:May 16, 2023PDF download

Biopreservation and BiobankingVol. 21, No. 6 EditorialFree AccessBest Practices Make PerfectAlison Parry-Jones and Clare M. AlloccaAlison Parry-JonesAddress correspondence to: Alison Parry-Jones E-mail Address: [email protected]ISBER President of the Board and Wales Cancer Biobank, Cardiff University, United Kingdom.Search for more papers by this author and Clare M. AlloccaISBER Past President of the Board and National Institute of Standards and Technology, Washington, District of Columbia, USA.Search for more papers by this authorPublished Online:15 Dec 2023https://doi.org/10.1089/bio.2023.29128.editorialAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail The International Society for Biological and Environmental Repositories (ISBER) is very proud to announce the publication of the 5th Edition of the ISBER Best Practices: Recommendations for Biorepositories. The ISBER Best Practices are a set of guidelines describing effective practices for the management of human and environmental repositories. The guidelines are an ideal starting point for new biobanks but also serve as an important reference tool for established repositories, especially those looking to introduce new areas of practice.The concept of working to “best practice” has been around throughout history although it has been suggested that the phrase was first coined in the 1960s1 in the business and financial management fields. Since then, the term has evolved and been adopted in many different sectors. In general, they are practices that are evidence and value-based practices that are known to produce good outcomes if followed. A review of literature suggests that the term surfaced most prominently in Chicago during the 1990s when Zemelman, Daniels, and Hyde collected what was then the “current, national consensus recommendations about ‘best educational practice,’” and gathered “all the traditional knowledge” to determine the “best” methods.2In biobanking, as within other sectors, there is a defined hierarchy of compliance requirements where legal instruments exist. Some countries, for example, Finland and Sweden, have direct biobanking laws. Countries/regions may also have relevant regulations, which are not laws themselves, but rather legal directives that explain implementation of statutes or laws. At the next level down, voluntary consensus standards such as ISO 20387 General Requirements for Biobanking and Best Practices3 are available—their use could be motivated by the needs of users or a biobank's desire to provide more assurance of products.For an individual biobank, the set of applicable laws, regulations, or standards may not be straightforward to identify, but is important to understand. Best Practices, however, are techniques, procedures, or methods that are used to maintain quality and fitness for purpose and are intended to complement standards as well as many laws and regulations; they should be both consensus and evidence based. The ISBER Best Practices, therefore, do not constitute a standard or legal instrument; rather, they are recommendations that can support the creation of standard operating procedures in the context of a repository's quality management system.They are not detailed procedures but guidelines to help develop and improve a biobank's policies and procedures. The term “Best Practice” is used throughout the ISBER document to describe a level of operation that is above the basic recommended practice. It is important to note that adoption of best practices will vary based on the goals and circumstances of a given repository. It is recognized that it may not be possible, or even desirable, for the designated “Best Practice” to be implemented in all instances.An important feature of the “ISBER Best Practices 5th Edition” is their broad and complementary applicability—a biobank may use them as a place to begin, or as an aid in achieving other goals, such as accreditation to a biobanking standard. This document was developed by experts who also have an understanding of complementary tools available from ISBER and others, for example, targeted and educational tools such as the Biobank Assessment Tool (BAT),4 Qualification in Biorepository Science (QBRS),5 the Canadian Tissue Repository Network (CTRNet) “Essentials of Biobanking” course,6 and standards such as ISO 203877 or College of American Pathologists Biorepository accreditation.8The Best Practices document was developed to be aligned with these other tools—the intent is that a biobank will be able to tailor a complementary set of tools for its purposes, as depicted in Figure 1.FIG. 1. The Biobanker's Toolbox: Types of Documentation.Of course, Best Practices are only ever “current” best practices—technologies evolve, knowledge advances, and what used to be the cutting edge, state of the art, eventually becomes outdated and superseded by new norms. For this reason, the ISBER Best Practices document is reviewed and updated regularly.The first edition was published in 2005,9 was limited to human specimen biobanks, and was United States centric. In 2008, the text was revised to broaden the scope to include environmental repositories and to have a wider more international perspective to reflect the growing global membership profile. The 2012 third edition expanded again to include cost management and specimen access, utilization, and destruction of biospecimens to recognize and better support the growing professionalism in the sector. The fourth edition, published in 2018, was the first edition to be translated into languages other than English.Volunteers translated the text into simplified Chinese, Japanese, Russian, Korean, and Spanish. It, too, was an updated and enhanced volume, reflecting the advances in biospecimen science and new technologies and, for the first time, a cryopreservation addendum was added with input from the Society for Cryobiology. The fourth edition translations10 will be available on the ISBER website until the fifth edition translations are available.The ISBER Best Practices 5th Edition document can be downloaded for free from ISBER's website at www.isber.org/for both ISBER members and nonmembers, and hard copies can also be purchased through Amazon. This is one of a set of tools and educational resources available on the ISBER website. It is on the reading list for the QBRS test, which was developed jointly by ISBER and The American Society for Clinical Pathology Board of Certification, and the BAT helps measure a biobank's compliance against the Best Practices document.ISBER's mission is to “advance the expertise and quality of biorepositories and biobanking science worldwide.” The Best Practices is a key document to strengthen the position of biobanks to meet the constantly evolving needs of the research community. These guidelines help enable biobanks to provide biomaterials fit for purpose and they accelerate new biobanks in meeting the needs of users. Ultimately, they help to raise the quality of biobanks across the globe, enabling interoperability and placing the biobank community on a shared path to increase and maximize utility.References1. Osburn J, Caruso G, Wolfensberger W. The concept of “best practice”: A brief overview of its meanings, scope, uses, and shortcomings. Int J Disability Dev Educ 2011;58(3):213–222; doi: 10.1080/1034912X.2011.598387 Crossref, Google Scholar2. Rumohr-Voskuil G. Best practice: Past, present, and personal. Lang Arts J Mich 2010;25(2), Article 6; doi: 10.9707/2168-149X.1073 Crossref, Google Scholar3. ISO 20387 General Requirements for Biobanking and Best Practices. Available from: https://www.iso.org/standard/67888.html [Last accessed: December 12, 2023]. Google Scholar4. Available from: https://www.isber.org/page/BAT [Last accessed: November 22, 2023]. Google Scholar5. Available from: https://www.isber.org/page/qualification [Last accessed: November 22, 2023]. Google Scholar6. Available from: https://www.isber.org/page/EssentialsBiobanking [Last accessed: November 22, 2023]. Google Scholar7. Available from: https://www.iso.org/standard/67888.html [Last accessed: November 22, 2023]. Google Scholar8. Available from: https://www.cap.org/laboratory-improvement/accreditation/laboratory-accreditation-program#:~:text=The%20CAP%20accredits%20laboratories%20performing,testing%20when%20required%20by%20law [Last accessed: November 22, 2023]. Google Scholar9. International Society for Biological and Environmental Repositories (ISBER). Best practices for repositories I: Collection, storage, and retrieval of human biological materials for research. Cell Preserv Technol 2005;3(1):5–48. Link, Google Scholar10. Available from: https://www.isber.org/page/BPR [Last accessed: November 22, 2023]. Google ScholarFiguresReferencesRelatedDetails Volume 21Issue 6Dec 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Alison Parry-Jones and Clare M. Allocca.Best Practices Make Perfect.Biopreservation and Biobanking.Dec 2023.533-534.http://doi.org/10.1089/bio.2023.29128.editorialPublished in Volume: 21 Issue 6: December 15, 2023PDF download

Biopreservation and BiobankingVol. 21, No. 1 ISBER CornerFree AccessPriorities and Future of the ISBER Standards Community of Practice and Pediatric Special Interest GroupClare Allocca, Mieke De Wilde, and Rania LabibClare AlloccaNational Institute of Standards and Technology, Gaithersburg, Maryland, USA.Search for more papers by this author, Mieke De WildeBelgian Cancer Registry, Brussels-Capital Region, Belgium.Search for more papers by this author, and Rania LabibBoston Children's Hospital Biobank Core Facility, Massachusetts, USA.Search for more papers by this authorPublished Online:14 Feb 2023https://doi.org/10.1089/bio.2023.29116.cjaAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail A key driver for ISBER's structural evolution is our desire to provide increased opportunities for engagement. As an introduction to some of these opportunities, a series of town halls is describing the objectives and plans for selected communities of practice (CoPs), working groups (WGs), and special interest groups (SIGs). The first of these town halls was held on December 13, 2022. Hosted by the ISBER Board of Directors (BOD), this first town hall addressed the work of the standards CoPs and the pediatric SIG. We wanted the membership to understand the priorities of each group and some of the new initiatives that are under development.The town hall began with an introduction from Clare Allocca, president of the BOD, who noted that ISBER continues to support the biobanking community through its technical groups—CoPs, SIGs, and WGs. It is intended that the combination of these group types offers an array of fora for discussions, networking, idea incubation, education, and product development. The first presentation of this town hall would describe a CoP: standards.Mieke De Wilde, Standards Community of Practice Chair, spoke about the foci for standards—education and tools. She highlighted the biobankers' toolbox that is available to biobankers, and noted that these various tools can assist biobanks in their quest to increase fitness for purpose. She highlighted several tools that are developed by ISBER—Standard PREanalyticalCode, qualification in biorepository science (QBRS), biobank assessment tool (BAT), the proficiency testing program at IBBL and internal audit tool (IAT), and noted how they can work together.Mieke then focused her presentation on the QBRS. She highlighted the partnership that we have with the American Society for Clinical Pathology—Board of Certification to develop this examination. She highlighted the usage of the BAT noting that we have more than doubled the number of users in 2022 compared with 2021 in both new users and repeat users.She noted that the fifth edition of ISBER Best Practices (BP) is currently under development. She highlighted that the new edition was based on a gap analysis that occurred in late 2021 and early 2022.Questions were fielded from the audience. A member asked for clarification on the difference between the BAT and the IAT. Mieke noted that the BAT allows for self-assessment of your biobank, whereas the IAT will facilitate biobanks to create an audit program, engage personnel, and implement the audit plan. People asked for clarification as to how the QBRS will change in years to come. Mieke noted that a review of the QBRS examination would be done in 2023. Members asked for feedback on how biobanks can raise funds; the panelists noted that support can come from charities, project support, and services.It was noted that biobankers have to ensure a case is made for funding both initially and ongoing. The group discussed how to develop a value proposition for biobanks. Next to financial revenue, the importance of sustainability in other domains was mentioned, such as in ethical, legal, and social issues; reproducibility of scientific output; and product development. Members asked whether the ISBER tools can be used more than once; Mieke noted that there is great value in using the tools for multiple years in a row.In doing so, the benefits of small quality improvement steps add to each other every time the biobank runs through the plan-do-check-act cycle. For example, repeated use of the BAT can inform the biobank on overall quality improvement over the years. The IAT can be used to develop a comprehensive audit program addressing all aspects of the biobank operations. Both can feed into an annual review of the biobanks quality policy.Clare introduced Dr. Rania Labib who represented the pediatric SIG. She noted that she wished to highlight the goals, activities, and dreams. She noted that the goal is to increase awareness and issues that may be of interest to this group. She highlighted the work that the SIG did to create a special issue in BIO in April 2021. She highlighted that another important role that this group tries to achieve is to develop a platform to exchange expertise. It is important to create a collaborative environment to increase accessibility for sample sharing. The group determined a new set of specific priorities for the future—(1) evaluate the ISBER BP from the pediatric perspective, (2) create better visibility to pediatric collections worldwide, and (3) to start having a platform and collaboration with pharma.Rania noted that the biggest challenge are the ethical concerns as the pediatric group deals with young patients and parents. It was noted that exchange of samples for this group is limited, which makes collaboration hard to initiate and maintain. Rania noted that the pediatric group helps facilitate collaboration. Rania noted that joining this group has helped her develop her passion; she noted that it is empowering to work with others who face similar challenges and brainstorm solutions to common problems. It is great to be able to work together. She noted that the SIG helped her network. On a personal and professional level, this has helped her. The group discussed the role of the pathologist and how we may be able to increase engagement; it was noted that pathologists should be involved in each step of biobanking.A general discussion ensued. The group suggested a toolkit for resource-constrained countries. Panelists highlighted that there are grants available for low and middle income countries to take the QBRS. The group discussed how we may get cross-talk between the SIGs, WGs, and CoPs. Mieke noted that multiple tools were developed in the biospecimen science WG and some are now updated by standards CoP. The group discussed the concept of evidence-based trust.Clare closed the session by noting that she hoped that we had inspired people to remain involved. The ISBER BOD will be hosting a second town hall that will feature the work of other CoPs, WGs, and SIGs in the new year. We invite all members to participate.FiguresReferencesRelatedDetails Volume 21Issue 1Feb 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Clare Allocca, Mieke De Wilde, and Rania Labib.Priorities and Future of the ISBER Standards Community of Practice and Pediatric Special Interest Group.Biopreservation and Biobanking.Feb 2023.114-115.http://doi.org/10.1089/bio.2023.29116.cjaPublished in Volume: 21 Issue 1: February 14, 2023PDF download

Biopreservation and BiobankingVol. 20, No. 6 ISBER CornerExplore Biobanking Issues: Get to Know ISBER's Working Groups and Special Interest GroupsClare M. Allocca, Lalita Wadhwa, Piper Mullins, Cheryl Michels, Yaffa Rubinstein, Suenne Orth, Andy Zaayenga, and Suzanne VercauterenClare M. AlloccaNational Institute of Standards and Technology, Gaithersburg, Maryland, USA.Search for more papers by this author, Lalita WadhwaBaylor College of Medicine, Houston, Texas, USA.Search for more papers by this author, Piper MullinsSmithsonian Institution, Washington, District of Columbia, USA.Search for more papers by this author, Cheryl MichelsFreezerworks, Mountlake Terrace, Washington, USA.Search for more papers by this author, Yaffa RubinsteinIndependent, Rockville, Maryland, USA.Search for more papers by this author, Suenne OrthF. Hoffmann-La Roche AG, Basel, Switzerland.Search for more papers by this author, Andy ZaayengaSmarterLab, Martinsville, New Jersey , USA.Search for more papers by this author, and Suzanne VercauterenBC Children's Hospital, Vancouver, Canada.Search for more papers by this authorPublished Online:16 Dec 2022https://doi.org/10.1089/bio.2022.29113.cjaAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Explore Biobanking Issues: Get to Know ISBER's Working Groups and Special Interest Groups." Biopreservation and Biobanking, 20(6), pp. 577–578FiguresReferencesRelatedDetails Volume 20Issue 6Dec 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:Clare M. Allocca, Lalita Wadhwa, Piper Mullins, Cheryl Michels, Yaffa Rubinstein, Suenne Orth, Andy Zaayenga, and Suzanne Vercauteren.Explore Biobanking Issues: Get to Know ISBER's Working Groups and Special Interest Groups.Biopreservation and Biobanking.Dec 2022.577-578.http://doi.org/10.1089/bio.2022.29113.cjaPublished in Volume: 20 Issue 6: December 16, 2022PDF download

Biopreservation and BiobankingVol. 20, No. 4 ISBER Corner ArticleRaising ISBER to an Even Higher Standard!Clare M. AlloccaClare M. AlloccaAddress correspondence to: Clare M. Allocca, MS, PMP, National Institute of Standards and Technology, Standards Coordination Office, 100 Bureau Drive, Stop 2100, Gaithersburg, MD 20899, USA E-mail Address: clare.allocca@nist.govPresident, ISBER Board.National Institute of Standards and Technology, Standards Coordination Office, Gaithersburg, Maryland, USA.Search for more papers by this authorPublished Online:17 Aug 2022https://doi.org/10.1089/bio.2022.29110.cjaAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byExplore Biobanking Issues: Get to Know ISBER's Working Groups and Special Interest Groups Clare M. Allocca, Lalita Wadhwa, Piper Mullins, Cheryl Michels, Yaffa Rubinstein, Suenne Orth, Andy Zaayenga, and Suzanne Vercauteren16 December 2022 | Biopreservation and Biobanking, Vol. 20, No. 6 Volume 20Issue 4Aug 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:Clare M. Allocca.Raising ISBER to an Even Higher Standard!.Biopreservation and Biobanking.Aug 2022.412-414.http://doi.org/10.1089/bio.2022.29110.cjaPublished in Volume: 20 Issue 4: August 17, 2022PDF download

The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools (e.g., standards, best practices, and plans) exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force has set out to identify needs and gaps in these tools and make recommendations for the next generation of available tools, having closely examined the COVID-19-related challenges. While conducting this work to examine the relationships between tools and biobank adaptability, a subgroup of the task force conducted a parallel effort to develop and describe individual COVID-19 era case studies based on a number of operating biobanks. Each case study presents a different combination of implemented tools. Observations and lessons learned from these case studies are provided, and experiences with tool implementation are discussed. This information is supplemented by data relating to tool usefulness that was obtained through an ISBER survey discussed in a companion article. The knowledge gained from this study will be combined with other task force efforts to make recommendations to better position the biobanking community in their response to future emergencies.

The era of COVID-19 has brought about a number of novel challenges for the global biobanking community. To better position the biobanking community to cope with current and future challenges, the International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force was convened to identify needs and gaps in biobanking tools (existing resources that support good practice), for example, standards, best practices, business, etc. and to make recommendations to benefit the community. Toward these goals, the Task Force assembled a set of questions to explore individual biobanks' experiences, with emphasis on identification of key challenges and approaches, including tools employed. A survey was designed with the use of these questions and administered by ISBER. This article presents a summary of the aggregated data obtained from the survey responses, illustrating some of the major issues encountered and identifying which tools the survey respondents found most useful. In particular, this article focuses on the challenges identified during the early months of the COVID-19 era. Recommendations are provided to support biobank emergency preparedness for the future, address lessons learned, and propose solutions to bridge identified gaps. The analysis and the complete survey dataset will also inform the larger Task Force goal to develop specific tool recommendations.

Regenerative medicine therapies—including advanced cell, gene, and tissue therapies—have the potential to treat and even cure many conditions and diseases. The realization of this potential requires the regenerative medicine field to forge from its early stages to a mature platform using potentially novel translational, manufacturing, and commercialization paradigms. As with any industry in its nascent stages, the field must surpass several barriers to achieve its market potential. Standards are a powerful tool in the protection of public health, safety, and the environment, development and commercialization of new technologies, and facilitation of national and international commerce. The standardization of practices, terminology, and infrastructure will provide the necessary base upon which regenerative medicine can drive innovative new therapies to market. This article provides an overview of documentary and physical standards and standards practices (with a focus on US policies), describes the drivers and benefits of standards implementation, and provides resources for standards relevant to regenerative medicine.

Recent advances in biotechnology are making it possible to advance science and improve healthcare with increasing speed and precision. Biobanking, as a foundation of the biotechnology infrastructure, is critical to the assurance of quality for many of the key components for these advancing technologies in both the human and nonhuman domains. Biobanking must advance to support the increased complexity and required precision needs of biological resources. Standards development can provide an important link for the research and development community by providing tools to ensure quality, fitness-for-purpose, and reproducibility in biobanking. ISBER has been developing the ISBER Best Practices revision. At the same time, ISO/TC276/ WG2 has been developing an International Standard (IS) ISO/DIS 20387 General requirements for biobanking standard. It is important that ISBER and ISO/TC276/WG2 harmonize and/or align their products to enable members of the diverse biobanking community to tailor their own suite of tools to support their specific needs. The availability of both standards and best practices that are complementary will maximize available support for all biobanks. The increased availability of complementary standards, tools, and best practices will facilitate the path to new biotechnology advances and a better future.

The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development.

Biopreservation and BiobankingVol. 15, No. 4 ISBER CornerISO/TC276/WG2 Biobanks and Bioresources: Draft International Standard Is Now Available for CommentClare M. Allocca, Marianna J. Bledsoe, Koh Furuta, and Nilsa C. RamirezClare M. AlloccaSenior Advisor for Standardization, Standards Coordination Office, National Institute of Standards and Technology, Gaithersburg, Maryland; Administrator, US Technical Advisory Group (TAG) to ISO/TC276 Biotechnology.Search for more papers by this author, Marianna J. BledsoeIndependent Consultant, Silver Spring, Maryland; Member, US TAG to ISO/TC276 Biotechnology.Search for more papers by this author, Koh FurutaClinical Pathologist, Kanagawa Cancer Center, Yokohama, Japan; ISBER Liaison to ISO/TC276 Biotechnology; Member, ISO/TC212, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems.Search for more papers by this author, and Nilsa C. RamirezAnatomic Pathologist, Nationwide Children's Hospital, Columbus, Ohio; Member, US TAG to ISO/TC276 Biotechnology and US Convenor, ISO/TC276/WG2 Biobanks and Bioresources.Search for more papers by this authorPublished Online:1 Aug 2017https://doi.org/10.1089/bio.2017.29025.cmaAboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byThe biobank of barretos cancer hospital: 14 years of experience in cancer research3 July 2021 | Cell and Tissue Banking, Vol. 23, No. 2A Biobank's Journey: Implementation of a Quality Management System and Accreditation to ISO 20387 Lara Mouttham, Susan J. Garrison, Denise L. Archer, and Marta G. Castelhano9 June 2021 | Biopreservation and Biobanking, Vol. 19, No. 3Preserving US microbe collections sparks future discoveries1 August 2020 | Journal of Applied Microbiology, Vol. 129, No. 2Biobanks—A Platform for Scientific and Biomedical Research16 July 2020 | Diagnostics, Vol. 10, No. 7Comparison and Analysis of Two Internationally Recognized Biobanking Standards Tamsin Tarling, Sheila O'Donoghue, Rebecca Barnes, Karlene Carvalho, Brent Gali, Marta Castelhano, Anne-Marie Mes-Masson, and Peter H. Watson9 April 2020 | Biopreservation and Biobanking, Vol. 18, No. 2Rationalized Development of a Campus-Wide Cell Line Dataset for Implementation in the Biobank LIMS System at Bioresource Center Ghent25 June 2019 | Frontiers in Medicine, Vol. 6Standardization and Innovation in Paving a Path to a Better Future: An Update of Activities in ISO/TC276/WG2 Biobanks and Bioresources Koh Furuta, Clare M. Allocca, Brent Schacter, Marianna J. Bledsoe, and Nilsa C. Ramirez1 February 2018 | Biopreservation and Biobanking, Vol. 16, No. 1Collections d'échantillons biologiques humains pour la recherche : principaux enjeux et conséquences pour le patient ?Therapies, Vol. 73, No. 1Collection of human biological samples for research purpose: Key challenges and patients' perspectivesTherapies, Vol. 73, No. 1 Volume 15Issue 4Aug 2017 InformationCopyright 2017, Mary Ann Liebert, Inc.To cite this article:Clare M. Allocca, Marianna J. Bledsoe, Koh Furuta, and Nilsa C. Ramirez.ISO/TC276/WG2 Biobanks and Bioresources: Draft International Standard Is Now Available for Comment.Biopreservation and Biobanking.Aug 2017.399-401.http://doi.org/10.1089/bio.2017.29025.cmaPublished in Volume: 15 Issue 4: August 1, 2017Online Ahead of Print:July 25, 2017PDF download