in vivo & in vitro potency testing 

Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. Charles River Biopharmaceutical Services (BPS) 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. These assays include adjuvant assessment, lot release potency, bacterial and viral challenge studies, and stability testing for a diverse range of products, including:

• Hormone potency assays (e.g., FSH, FSH-LH and hCG)
• Vaccines
• Neurotoxins
• Allergens
• Anti-venoms
• Bacteria
• Blood Products

BPS is a leader in determining the potency of botulinum toxins and has extensive experience with vaccine immunogenicity studies (e.g., Japanese Encephalitis Vaccine, Diphtheria and Tetanus Vaccine). We also have influenza challenge study capabilities working with BSL-2 pathogens. Many of our in vivo bioassays are able to be performed according to Ph. Eur. or USP guidelines. JP is also available upon request.

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 EPO, PTH, G-CSF, GM-CSF, interferons and monoclonal antibodies. We are also working on developing new bioassays for the emerging biosimilars market. For more information on our bioassays, click here.

To check which of our BPS facilities offer in vivo and in vitro potency testing services, click here. For additional information, please contact us at askcharlesriver@crl.com.