Saturday, 16 June 2018

Rapid mycoplasma testing method approved

Manufacturers of cell-culture-based therapeutics can now rely on a faster method for detecting mycoplasma contamination. The Applied Biosystems MycoSEQ Mycoplasma Detection Kit is a fully integrated solution for real-time PCR-based mycoplasma detection. Used throughout the bioproduction workflow, the MycoSEQ method is an alternative to costly, time-consuming culture-based tests often done externally by contract labs, which can take up to 28 days.

Following validation, regulatory review, and acceptance, the MycoSEQ assay and method can be used for lot release by manufacturers in different therapeutic modalities including biotherapeutics, cell and gene therapies, vaccines, and other cell-culture-based therapeutics.

To date, nine global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.

See: ThermoFisher

Posted by Dr. Tim Sandle

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