Bioactivity & Potency Testing
Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products; therefore, bioassays are central and critical for product development and manufacturing. These assays are necessary to ensure the continued quality, safety and efficacy of biopharmaceutical products, and also for the confirmation of biocomparability of innovator and biosimilar product. In turn, these assays must be reliable, standardized, and relevant to reflect the product’s mode of action.
Bioactivity & Potency Determination Assay
With extensive experience in establishing, validating, and conducting routine bioassays to GMP standards, Charles River has the capability to perform a comprehensive array of both in vitro and in vivo bioassays for a variety of biologically active molecules.
Our full range of services for bioassay development include method development, method transfer, method optimization, ICH-compliant method validation, lot release testing for drug substance and drug product, stability testing, accelerated stress condition testing, and comparability testing between innovator and biosimilar biological products.
In Vitro Bioassays
In Vivo Bioassays