Roche and Lonza have announced that they have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL mycoplasma PCR assays. MycoTOOL detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation.
Additionally, Lonza offers contract testing services using the MycoTOOL test. MycoTOOL test is the first commercial NAT-based detection system that is used for mycoplasma biosafety testing of approved biological products.
Release testing with the MycoTOOL PCR-test from Roche Custom Biotech, a part of Roche Applied Science has been approved by the European Medicines Agency (EMA) for several pharmaceutical products. It is the first commercially available mycoplasma PCR-test that is used to replace traditional mycoplasma tests (cell-dependent and cell-independent culture methods) during pharmaceutical production.
Developed and manufactured within a regulated environment, the product design, production process, change control notification procedure, premium quality products, logistics, and fulfilment systems help ensure that the products retain their proven high quality.
Robert Yates, Head of Roche Applied Science, commented: “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.”
“Roche and Lonza share the rare combination of being both consumers and providers of pharmaceutical quality control and diagnostics products. This internal integration of user and manufacturer helps ensure products align properly with user requirements and capabilities. The unique perspective of being a user of the very products you sell provides insight unattainable from the outside looking in. We are pleased to be working with Roche in bringing this advancement to our colleagues,” said Lukas Utiger, Head of Lonza BioSciences.