Comprehensive Evaluation of Compendial USP<71>, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants

Author:

England Matthew R.1,Stock Frida1,Gebo James E. T.1,Frank Karen M.1,Lau Anna F.1

Affiliation:

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

Abstract

The emergence of cell therapy programs in large academic centers has led to an increasing demand for clinical laboratories to assist with product sterility testing. Automated blood culture systems have shown promise as alternatives to the manual USP<71> compendial method, but current published data are limited by small organism test sets, particularly for molds.

Funder

HHS | National Institutes of Health

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference33 articles.

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3. Engineered cell therapy for cancer gets thumbs up from FDA advisers

4. Code of Federal Regulations. 2012. Title 21. Food and drugs. Chapter I. Food and Drug Administration, Department of Health and Human Services. Subchapter F. Biologics. Part 610. General biological products standards. 21 CFR 610. U.S. Government Publishing Office, Washington, DC. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=610.

5. U.S. Pharmacopeia. 2018. USP<71>Sterility tests, p 5984–5991. In 2018 United States Pharmacopeia and National Formulary. USP 41-NF 36. U.S. Pharmacopeial Convention, Rockville, MD.

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