NEW YORK (GenomeWeb News) – Roche said today that the US Food and Drug Administration has accepted the use of Roche's PCR-based mycoplasma detection test for release testing of a Roche biopharmaceutical product.
Roche said that its test, called MycoTool, is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product.
Mycoplasms frequently cause 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.
Such tests, Roche said, require as many as 28 days to complete and are laborious and difficult to interpret. MycoTool, on the other hand, takes approximately one day to complete.
In April 2011, Swiss pharmaceutical products and services firm Lonza became the distributor of MycoTool under a co-exclusive agreement between the companies.