MycoTOOL test is a 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 for several pharmaceutical products.
The mycoplasma PCR-test 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 quality.
Lonza BioSciences head Lukas Utiger said 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," Utiger said.
MycoTOOL detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation.