Roche's Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance for Release Testing of Biopharmaceutical Roche Product

Roche's Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance for Release Testing of Biopharmaceutical Roche Product PR Newswire PENZBERG, Germany, December 19, 2012 PENZBERG, Germany, December 19, 2012 /PRNewswire/ -- First commercially available mycoplasma PCR test accepted by FDA reduces time for detection from one month to one day Today Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche's biological products. It is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product that can replace conventional and time-consuming mycoplasma detection assays based on culture methods. 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. "Mycoplasma contamination represents a significant issue during biological drug production," said Ruedi Stoffel, Head of Custom Biotech at Roche.