Roche Mycoplasma PCR test approved by EMEA
Roche Applied Science has developed the first commercially available Mycoplasma PCR test that replaces traditional Mycoplasma tests (culture method as well as indicator cell culture method) during pharmaceutical production. The European Medicines Agency (EMEA) has approved it for release testing of a Roche pharmaceutical product.
In June, the US Food and Drug Administration (FDA) approved the PCR concept of this test for seven commercial products from Genentech. Bayer Health Care has also received approval for a pharmaceutical product from the EMEA and Japan’s Ministry of Health, Labour and Welfare (MHLW) using the same PCR-based test concept.
MycoTOOL is now globally available for use as a Mycoplasma PCR release test for pharmaceutical products. The test kit provides all critical reagents for performing a sample preparation and PCR.
Mollicutes/mycoplasmas are frequent causes of contamination in biopharmaceutical production, cell therapy and tissue engineering. Traditional detection methods required by pharmacopoeias and regulatory authorities worldwide use growth on culture media to detect contamination. Roche says these culture-based techniques are time-consuming, take a minimum of 28 days to complete and it may not be possible to cultivate certain Mollicutes species. Rapid microbial tests are urgently needed to facilitate faster detection and more rapid corrective action.
Roche has developed and implemented a PCR test for pharmaceutical processes. A specific quality of reagents, guaranteed to be nucleic acid free according to the current Quality Control procedures, allows a new level of sensitivity, the company says. The design and production process for the MycoTOOL PCR test are monitored through change control notification within the Roche quality system. www.roche.com