Roche said this week that the Canadian Health Authority has accepted the use of its PCR-based mycoplasma detection test MycoTool for release testing of an undisclosed Roche biological product.
Roche said that the test can replace conventional and time-consuming mycoplasma detection assays based on culture methods. The assay was accepted by the US Food and Drug Administration late last year for release testing of an undisclosed Roche biopharmaceutical product (PCR Insider, 12/20/2012).
Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods use growth on culture media and in vitro assays to detect contaminating organisms. These growth-based methods require as many as 28 days to complete, are laborious, and difficult to interpret, Roche said.
The MycoTool PCR kit provides all critical reagents for sample preparation and PCR. It offers sensitivity of less than 1 colony-forming unit/ml for most isolates and is compatible with a diverse spectrum of sample types including primary and continuous human cells, canine cells, nonhuman primate cells, many different rodent cell types, and cell-free matrices (culture supernatants of CHO or human stem cells, and egg-derived samples). The assay also detects the broad panel of Mollicute species due to universal primer design.