Roche has 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.
Stoffel continued, “Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products.”
On the occasion of the acceptance, an additional lecture about the MycoTool test was added to the agenda of the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Munich.