Roche releases validation report for MycoTOOL Real-Time PCR Kit

Roche has announced the launch of a new validation report for its MycoTOOL Real-Time PCR Kit, in order to help drive up quality control for biopharmaceutical products.

Validated by the Roche Pharma division, the report helps customers to decide which quality control and validation strategy to use with their applications when using the kit, regardless of whether Chinese hamster ovary cells or other cell types are being used.

Launched in 2012, the MycoTOOL Real-Time PCR Kit is a mycoplasma test based on real-time polymerase chain reaction technology that helps to improve the efficiency and quality of manufacturing processes.

Reducing testing times to hours instead of days, it is the successor to the MycoTOOL PCR Mycoplasma Detection kit, which has been accepted as a release test in more than 150 countries.

The company said: "The MycoTOOL Real-Time PCR Kit has been developed to meet the requirements of the European Pharmacopeia EP 2.6.7. Roche is planning additional tests for residual DNA and has other portfolio expansions currently underway."

Roche recently agreed a deal to acquire Ariosa Diagnostics, a molecular diagnostics testing service provider based in California. This will allow the company to enter the non-invasive prenatal test and cell-free DNA testing services markets for the first time.