Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. Bioassays are used to determine the potency of a biopharmaceutical by comparing the biological response related to its mode of action with that of a control preparation. The data generated by bioassays are typically analyzed using biostatistical methods.
With extensive experience in establishing, validating and conducting routine bioassays to Good Manufacturing Practice (GMP) standards, Charles River Biopharmaceutical Services (BPS) has the capability to perform a comprehensive array of both in vitro and in vivo bioassays for a variety of biologically active molecules.
Bioassay Services
Bioassay and Products
Technologies and Readouts
For details on the location of services performed, please click here. For more information about our bioassays, contact us at askcharlesriver@crl.com.
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bioassay, bioassays, in vivo bioassays, in vitro bioassays, potency assays, cell-based bioassays, flow cytometry, Forward Scatter, FSC, Sideward Scatter, SSC, granularity, cGMP, monograph, Cytotoxicity, cell proliferation, Cell survival, EC50 determination, Four-parameter fit, Five-parameter fit, Parallel line analysis, interferons, IFN-α, IFN-β
Bioassays | Charles River Biopharmaceutical Services
Bioassays are used to determine the potency or biological activity of a biopharmaceutical. We perform in vitro and in vivo bioassays for a variety of biologically active molecules.