In Vivo Bioassays

With extensive experience conducting in vivo bioassays for the purpose of showing efficacy and safety, 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. Assays include adjuvant assessment, lot release potency, bacterial and viral challenge studies, and stability testing for a diverse range of products, including:

  • Vaccines
  • Neurotoxins
  • Allergens
  • Antivenoms
  • Bacteria
  • Blood products
  • Hormones (e.g., FSH, FSH-LH, hCG and HGH)

Developing Effective and Safe Vaccines

At this seminar, three of our scientists share what you need to know to boost the productivity, efficiency, and profitability of your vaccine programs.
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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.

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Release Testing

Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.