Mycoplasma Detection acc. to Pharmacopoeias — Ready-to-Use

Mycoplasma testing in biopharmaceutical, vaccine, cell culture, and virus culture manufacturing

Mycoplasma testing and detection is preformed because contamination with these bacteria can pose a significant challenge for biopharmaceutical manufacturing. Cell cultures are vulnerable to contamination from operators and contaminated raw materials.

Mycoplasmas are difficult to detect in cell cultures as they generally do not lead to visual turbidity in media or to pH changes. However, contamination can affect host cell metabolism and expression levels and ultimately lead to the loss of cell lines. Since the root cause of mycoplasma contamination can only be identified 50 % of the time, it is important to implement a comprehensive program within the biotechnology manufacturing process to prevent, reduce and detect mycoplasma contamination. Therapeutic products for both human and animal use are required to undergo mycoplasma testing throughout various steps in the production process.

Why test for mycoplasmas?

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, and more importantly cause side effects in patients who are administered the final vaccine product.

Without rigorous mycoplasma testing routines, mycoplasma contamination of biopharmaceutical production batches is extremely difficult to discover because the presence of mycoplasmas 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.

About mycoplasma

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 stabilize their cytoplasmic membranes most mycoplasma species require sterols, which they take up from their environment, usually as cholesterol from their animal hosts.

Ready-to-use mycoplasma detection acc. to European pharmacopoeia 6.1 (2.6.7.) and USP 35 (63)

We provide a complete portfolio of ready-to-use liquid and solid culture media required for detecting mycoplasmas according to European Pharmacopoeia 6.1 (2.6.7.) and USP 35 (63). Without any further preparation steps, our ready-to-use mycoplasma culture media offer a constant product quality and a complete traceability with lot specific certificates of analyses.