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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1-Hour In-House Mycoplasma Testing for Cell & Gene Therapies

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

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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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