Roche announced that the Canadian Health Authority has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. The test can replace conventional and time-consuming mycoplasma detection assays based on culture methods and was also accepted by the FDA end of last year.
Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret. Read the full story.