Lonza and Roche announced today that they have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL® mycoplasma Polymerase Chain Reaction (PCR) assays. PCR is a commonly used molecular biology technique that amplifies a single copy of nucleic acid to generate millions of copies of a particular DNA sequence. MycoTOOL® utilizes PCR methodology for DNA target amplification and gel electrophoresis for same day detection, compared to standard methods that can take up to 28 days to achieve results.
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. The 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 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.