NEW YORK (GenomeWeb News) – Roche and Lonza today announced an exclusive co-distribution deal for the commercialization of Roche's MycoTool mycoplasma PCR assays.
As a result, MycoTool kits are now available from Lonza for final release testing for pharmaceutical products upon validation. Lonza also offers contract testing services using the MycoTool test, which is the first commercial nucleic acid testing-based detection system for mycoplasma biosafety testing of approved biological products, the two firms said.
Financial and other terms of the deal were not disclosed.
Release testing with the MycoTool PCR-based test from Roche Custom Biotech has been approved by the European Medicines Agency for several pharmaceutical products. The test is the first commercially available mycoplasma PCR-based test for replacing traditional mycoplasma tests, which use cell-dependent and cell-independent culture methods during pharmaceutical production, Roche and Lonza said.