Sterility Testing for Hematopoietic Stem Cells-Reference-Cited by-同舟云学术

Sterility Testing for Hematopoietic Stem Cells

Published:2023-03-23 Issue:3 Volume:61 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Cundell Tony¹,Atkins J. Wade²,Lau Anna F.³^ORCID

Affiliation:

1. Microbiological Consulting, LLC, Rye, New York, USA

2. Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA

3. Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA

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.

Funder

Intramural Research Program at the National Institutes of Health Clinical Center

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/jcm.01654-22

Reference49 articles.

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/regulatory-for-cellular-therapies/biological-products. Accessed 9 January 2023.

2. US Food and Drug Administration. 2022. Interactions with Office of Tissues and Advanced Therapies. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/interactions-office-tissues-and-advanced-therapies. Accessed 28 November 2022.

3. 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?CFRPart=1271. Accessed 1 December 2022.

4. 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/subpart-B/section-610.12. Accessed 1 December 2022.

5. US Pharmacopeia—National Formulary. 2022. USP<71> Sterility tests in USP43-NF38. US Pharmacopeia, Rockville, MD.

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