New Roche Mycoplasma PCR Test Replaces Culture Testing During Pharmaceutical Production

In July 2009 the new MycoTOOL PCR test from Roche Applied Science was approved by the European Medicines Agency (EMEA) for release testing of a Roche pharmaceutical product. It is said to be the first commercially available Mycoplasma PCR test that can replace traditional Mycoplasma tests during pharmaceutical production.

In June 2009 the FDA approved the PCR concept of this test for seven commercial products from Genentech. Earlier, Bayer Health Care 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 an easy to use 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 Mollicutes contamination. These culture-based techniques are time consuming and require a minimum of 28 days to complete.