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.

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Contamination Testing

Charles River offers a portfolio of compendia assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro and biochemical viral detection assays.

Biosimilar Support

Charles River delivers client-focused solutions for the specific testing and manufacturing requirements of your biosimilar.

Viral Clearance

Using a customized approach, we are able to provide technical advice and regulatory support to ensure that a successful and cost-effective viral clearance program is established executed.