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Scientific Study Summary: BIOFIRE® Mycoplasma For Cell & Gene Therapy Samples

Two cell therapy and four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 system with up to 9 compendial mycoplasma strains in the presence of high density chimeric antigen receptor T (CAR T) or Chinese hamster ovary (CHO) cells.

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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.
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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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WHITE PAPER

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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