Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. We can aid in the development of an in vivo potency assay through range-finding studies using investigation parameters, such as dose level and route of administration, followed by validation and implementation. We also have experience conducting in vivo bioassays to show efficacy and safety for a diverse range of products, including hormones, vaccines, neurotoxins, allergens, anti-venom, bacteria and blood products.
In vitro bioassays can also be 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. We offer cell-based bioassays for the determination of potency of many types of products, including EPO, PTH, G-CSF, GM-CSF, interferon and multiple monoclonal antibodies. Charles River is also able to provide expert opinions and support for the analysis of biosimilars using bioassays.