Roche has announced that the Canadian Health Authority has approved the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of its biological products.
Accepted by the FDA at the end of 2012, the test can replace the time-consuming mycoplasma detection assays which are based on culture methods. The test minimizes the risk associated with false negative and false positive test results.
The MycoTOOL PCR Mycoplasma Detection Kit offers a high sensitivity (<1 CFU/ml for most isolates) and detects the broad panel of Mollicute species, including more than 150 species due to universal primer design.
Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing.
Roche Custom Biotech head Ruedi Stoffel said that the Mycoplasma contamination represents a significant issue during biological drug production.
"Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products," Stoffel added.
Requiring nearly 28 days to complete, the conventional detection methods use growth on culture media and in vitro assays to detect contaminating organisms and these growth-methods are time-consuming. MycoTOOL PCR Mycoplasma Detection Kit reduces this time from one month to one day.