Roche and Lonza entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL mycoplasma PCR assays. The detection kits will be made available through Lonza for final-release testing of pharmaceutical products. Additionally, Lonza will offer contract testing services. MycoTOOL test is a NAT-based detection system that is used for mycoplasma biosafety testing of approved biological products.
Release testing with MycoTOOL has been approved by the EMA for several pharmaceutical products. The product design, production process, change control notification procedure, premium quality products, logistics, and fulfillment systems help ensure that the products retain their proven high quality, Roche and Lonza explain.
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. These culture-based techniques require a minimum of 28 days to complete.
The PCR-based MycoTOOL test can be used in place of traditional mycoplasma testing methods. “Lonza’s reputation for quality and customer care gives us confidence that MycoTOOL will be placed in the right applications for customers who wish to perform rapid mycoplasma testing in-house and for those who prefer to send their samples to a qualified outside laboratory for testing,” says Robert Yates, head of Roche Applied Science.