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.