FDA approves MycoTOOL mycoplasma test

摘要

The US FDA has approved Roche's PCR-based mycoplasma detection test for release testing of a Roche biological product. Roche says the MycoTOOL is the first commercially available mycoplasma PCR test accepted by the FDA for this purpose and can replace conventional mycoplasma detection assays based on culture methods. "Mycoplasma contamination represents a significant issue during biological drug production," said Ruedi Stoffel, head of Custom Biotech at Roche. "Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products."