New Roche Mycoplasma PCR Test Replaces Time-Consuming 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 the first commercially available Mycoplasma PCR test that can replace traditional Mycoplasma tests (culture method as well as indicator cell culture method) 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. Furthermore, the cultivation of certain Mollicutes species may not be possible. Rapid microbial tests are urgently needed to facilitate faster detection and more rapid corrective action.

As an integrated pharmaceutical and diagnostic company, Roche has developed and implemented PCR testing for pharmaceutical processes. A specific quality of reagents, that is guaranteed to be nucleic acid free according to the current Quality Control procedures, allows a new level of sensitivity. The design and the production process for the MycoTOOL PCR test are monitored via change control notification within the state of the art Roche quality system, ensuring that the product will retain its proven high quality.