Compendial Mycoplasma Testing

Biopharmaceutical facilities which use eukaryotic cells for the production of vaccines have to test their cell banks and virus seed lots as well as bulk vaccines for contamination with mycoplasmas. Species from this bacterial genus infect eukaryotic cells, disrupting their growth and metabolism. When mycoplasmas interfere with vaccine production, this may affect protein quality and yields, but more importantly it may cause side effects in patients who are administered the final vaccine products.

Without rigorous testing routines, mycoplasma contamination of biopharmaceutical production batches is extremely difficult to discover because mycoplasma presence does not generally lead to pH changes or visual turbidity in the media. The compendial mycoplasma test method involves both culture and indicator cell tests to detect mycoplasmas. If only two media are used for analysis, it is recommended to use FREY and FRIIS media in combination.

Mycoplasmas are among the smallest bacteria known. Due to their lack of cell wall structures they are able to pass filters with pore sizes of 0.2 µm. They grow aerobically or under facultative anaerobic conditions.

Mycoplasmas are either parasitic or saprophytic. Several species, such as M. pneumoniae, are pathogenic, causing pneumonia and other respiratory disorders in humans. M. genitalium is presumably involved in pelvic inflammatory diseases. Mycoplasmas do not respond to antibiotics which target cell wall synthesis, like penicillin. To stabilise their cytoplasmic membranes most mycoplasmas require sterols, which they take up from their environment, usually as cholesterol from their animal hosts.