Comparison of Five Commercial Molecular Assays for Mycoplasma Testing of Cellular Therapy Products
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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.
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Mycoplasma pose a persistent threat to cell culture systems due to their intracellular parasitic nature, lack of a cell wall, and resistance to standard antibiotics.
“Mycoplasma are among the smallest prokaryotic organisms and pose a persistent threat to cell culture systems due to their intracellular parasitic nature, lack of a cell wall, and resistance to standard antibiotics (Totten et al., 2023).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Totten et al., 2023
The Abstract (page unavailable) describes Mycoplasma contamination of cell cultures as common and an ongoing safety concern, supporting the claim that it poses a persistent threat. The passages do not attribute that threat to intracellular parasitism, lack of a cell wall, or resistance to standard antibiotics; they also do not establish the citing sentence’s description of Mycoplasma as among the smallest prokaryotes. (LLM, conf=0.88)
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Cites
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Cited by
Sorted by citations
Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17 · see citing works
Mycoplasma Contamination of Primary Cell Cultures
A. Leonovich, O. (2026) · Biochemistry · doi:10.5772/intechopen.1013412
- Authors
- Totten, A. H., Adams, A. J., Halas, H. K., Gebo, J. E. T., East, A. D., & Lau, A. F.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- Lau, Anna F.
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2023-02-22
- Volume
- 61
- Issue
- 2
- Pages
- e0149822-e0149822
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC9945500
- OpenAlex
- W4317752011
- Cited by
- 10
- References
- 1
- Citations by year
- 2026: 3 · 2025: 6 · 2023: 1
- FWCI
- 1.84
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Funders
- NIH Intramural Research Program
- Topics
- Life Sciences › Immunology and Microbiology › Microbiology › Microbial infections and disease research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Keywords
- mycoplasma testing, cellular therapy products, molecular detection assay, assay sensitivity, detection limit, assay interference, tumor-infiltrating lymphocytes, culture-based methods
- MeSH terms
- Humans, Mycoplasma, Reference Standards, Cell Culture Techniques, Limit of Detection, Cell- and Tissue-Based Therapy
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