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, specialized 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.