Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?-Reference-Cited by-同舟云学术

Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?

Published:2020-06-24 Issue:7 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Gebo James E. T.¹,Lau Anna F.¹

Affiliation:

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

Abstract

Sterility testing of cellular therapy products along with the associated environmental monitoring requirements for aseptic facilities, including compounding pharmacies, continues to impact clinical microbiology laboratories, as evidenced by the numerous discussions recurring on American Society for Microbiology Division C and ClinMicroNet listservs. This minireview provides an overview of this complex field of current good manufacturing practices (cGMP) based on biopharmaceutical industry standards and summarizes the compendial and alternative rapid microbial test methods available for product sterility and Mycoplasma testing.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01492-19

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