Monday 10 October 2022

Mycoplasma And Cell Therapy Risks

Mycoplasmas are undesirable, common contaminants, and difficult to detect risk factors for human and animal cell lines. Mycoplasmas can alter infected cells at the molecular level and trigger visible changes in cell morphology and growth characteristics. Cell lines are of great importance of biopharmaceutical manufacturing and research, and they are required for many of the new generation of Advanced Therapy Medicinal Products (ATMPs).


A recurrent of concern with the maintenance of viable cell cultures is contamination with mycoplasmas and mycoplasma contaminations are difficult to detect and undesirable in ATMP, especially for immunosuppressed patients. Rates of contamination vary, and these are control dependent, although a contaminated eukaryotic cell line can contain 1 million to 100 million organisms/mL. The effect of mycoplasma contamination within a cell culture is to alter cell physiology, produce erroneous results and lead to the loss of unique cell lines.


This review paper looks at mycoplasmas, the importance of cell lines (with special focus on ATMPs), and methods to eradicate and detect them.




Sandle, T. (2022) Mycoplasma And Cell Therapy Risks, Journal of Validation Technology, 28 (1): DOI:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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