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Review
. 2023 Mar 23;61(3):e0165422.
doi: 10.1128/jcm.01654-22. Epub 2023 Feb 27.

Sterility Testing for Hematopoietic Stem Cells

Tony Cundell  1 , J Wade Atkins  2 , Anna F Lau  3
Affiliations
Review

Sterility Testing for Hematopoietic Stem Cells

Tony Cundell et al. J Clin Microbiol. .

Abstract

Over the last two decades, rapid technological advances have led to the wide adoption of cell and gene therapy products for the treatment of a variety of disease states. In this study, we reviewed the literature between 2003 and 2021 to provide a summary of overarching trends associated with microbial contamination in hematopoietic stem cells (HSCs) derived from peripheral blood, bone marrow, and cord blood. We provide a brief background on the regulatory context for human cells, tissues, and cellular and tissue-based products (HCT/Ps) as regulated by the US Food and Drug Administration (FDA), sterility testing expectations for autologous (Section 361) and allogeneic (Section 351) HSC products, and discuss clinical risks associated with the infusion of a contaminated HSC product. Finally, we discuss the expectations for current good tissue practices (cGTP) and current good manufacturing practices (cGMP) for the manufacturing and testing of HSC based on Section 361 and Section 351 categorization, respectively. We provide commentary on what is practiced in the field and discuss the critical need for updates to professional standards that keep pace with advancing technologies with an aim to clarify expectations for manufacturing and testing facilities to improve standardization across institutions.

Keywords: bone marrow; clinical risk; contamination; cord blood; hematopoietic stem cells; peripheral blood; sterility testing.

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Conflict of interest statement

The authors declare a conflict of interest. T.C. provides consulting services to BioMerieux. J.W.A. and A.F.L. declare no conflicts of interest.

References

    1. Association for the Advancement of Blood & Biotherapies. 2023. Biological products, on Association for the Advancement of Blood & Biotherapies. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulato.... Accessed 9 January 2023.
    1. US Food and Drug Administration. 2022. Interactions with Office of Tissues and Advanced Therapies. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-produ.... Accessed 28 November 2022.
    1. US Food and Drug Administration. 2022. Title 21, Part 1271—Human cells, Tissues, and cellular and tissue-based products. 21 CFR 1271. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?C.... Accessed 1 December 2022.
    1. US Food and Drug Administration. 2022. Title 21, Part 610.12—Sterility. 21 CFR 61012. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-610/su.... Accessed 1 December 2022.
    1. US Pharmacopeia—National Formulary. 2022. USP<71> Sterility tests in USP43-NF38. US Pharmacopeia, Rockville, MD.

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