Lonza and Roche announced that they has 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. This 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.

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’s Bioscience Division.

Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.

Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically and has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products.