Scientific Posters

Testing Bioproduction Samples Using the BIOFIRE® Mycoplasma Molecular Lab in a Pouch System

The BIOFIRE® FILMARRAY® 2.0 Industry system utilizes a filmarray instrument and next generation PCR testing where all reagent components are contained in a closed pouch to detect the presence of more than 130 species of mycoplasma. The system provides sample to answer in ~1 hour with little technical training providing options for bringing mycoplasma testing directly to the production floor where critical testing is needed.

We present data from four bioproduction manufacturers that evaluated the BIOFIRE FILMARRAY 2.0 Industry system with up to 9 compendial mycoplasma species in the presence of high-density monoclonal antibody-producing Chinese hamster ovary cells. Studies were designed to assess product interference and detection, and two distinct protocols were evaluated: a protocol using 10 mL of product sample that provides the sensitivity for release testing, and a direct-test protocol using 0.2 mL product sample that allows for at-line in-process control testing.

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