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Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma Testing

This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products. Several PCR-based assays are commercially available, yet these typically still require extensive hands-on-time for sample preparation and nucleic acid extraction, specialised personnel and dedicated test areas.

A novel PCR-based technology that overcomes these hurdles, BIOFIRE® Mycoplasma, was recently tested and validated at Janssen, Pharmaceutical Companies of Johnson & Johnson. The presentation covers the collaborative effort between different functions to achieve validation and includes details of J&J’s future implementation of the automated PCR technology at multiple (bio)pharmaceutical drug substance production and ATMP drug product sites.

Interested In Saving Time and Money? Contact Our Experts for More Information on BIOFIRE® Mycoplasma.