Bioassay Method Development, Validation & Testing Services
Charles River can aid in the development of an in vivo potency assay through range-finding studies by investigating parameters such as dose level and route of administration, followed by validation and implementation. We have experience conducting in vivo bioassays for the purposes of showing 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, such as FSH, FSH-LH, PMSG, and hCG (performed to either EP or USP)
- Vaccines, including immunopotency, immunogenicity, antisera generation, and challenge studies (bacteria/viruses)
Charles River is a leader in determining the potency of botulinum toxins and has extensive experience with vaccine immunogenicity studies (e.g., Japanese Encephalitis, Diphtheria and Tetanus). Influenza challenge study capabilities working with BSL-2 pathogens are also available. Many in vivo bioassays are able to be performed according to EP, USP or JP guidelines.