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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.

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Learn How the BIOFIRE® Mycoplasma "Molecular Lab In A Pouch" Automates Testing With a Shorter Time-To-Result

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Benefits For Cell Therapy Manufacturers 

Learn about the value that BIOFIRE® Mycoplasma can bring to your operation, from reduction in costs to shorter time to result.

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BIOFIRE® Mycoplasma

BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
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Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).
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