Comparison of Five Commercial Molecular Assays for <i>Mycoplasma</i> Testing of Cellular Therapy Products-Reference-Cited by-同舟云学术

Comparison of Five Commercial Molecular Assays for Mycoplasma Testing of Cellular Therapy Products

Published:2023-02-22 Issue:2 Volume:61 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Totten Arthur H.¹^ORCID,Adams Anna Julia²,Halas Hyunmi K.³,Gebo James E. T.²,East Amanda D.²,Lau Anna F.²^ORCID

Affiliation:

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

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

3. Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

Abstract

Testing of cellular therapy products for Mycoplasma is a regulatory requirement by the United States Food and Drug Administration (FDA) to ensure the sterility and safety of the product prior to release for patient infusion. The risk of Mycoplasma contamination in cell culture is high.

Funder

NIH Intramural Research Program

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/jcm.01498-22

Reference25 articles.

1. United States Pharmacopeia. 2022. General chapter, <63> mycoplasma tests, USP41-NF36. United States Pharmacopeia, Rockville, MD.

2. European Pharmacopeia. 2008. 2.6.7. Mycoplasmas. European Directorate for the Quality of Medicines and Healthcare, Council of Europe, Strasbourg, France.

3. Pharmaceuticals and Medical Devices Agency. 2021. Japanese pharmacopoeia 18th edition. https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0029.html.

4. Biological Products: Cellular Therapy and FDA Approved Products

5. Prevention and detection of Mycoplasma contamination in cell culture;Nikfarjam L;Cell J,2012

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