Date: 2011-04-11
Type of information: Distribution agreement
Compound: MycoTOOL® mycoplasma Polymerase Chain Reaction (PCR) assays
Company: Lonza (Switzerland) Roche (Switzerland)
Therapeutic area:
Type agreement: distribution
Action mechanism: 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.
Disease:
Details: Lonza and Roche have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL® mycoplasma Polymerase Chain Reaction (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. 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.
Financial terms:
Latest news:
