In Vitro Bioassays

Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products. Charles River offers in vitro bioassays to cover a range of products, including assays targeting the emerging biosimilars market.

Determining Biocomparability of Your Product?

Services for bioassays include:

  • Method development
  • Method transfer
  • Method optimization
  • ICH-compliant method validation
  • Lot release testing for drug substances
  • Stability testing
  • Comparability testing between innovator and follow-on biologic
  • Accelerated stress condition testing

A general overview of these assays is available in our In Vitro Bioassays datasheet. For more in-depth information about our experience with monoclonal antibody therapeutics and hormone and cytokine therapeutics, please access the technical sheets located in the Source, a portal of our technical, scientific and educational resources.

  • Cell proliferation assays
    • Cell-based potency assays for EPO, PTH, G-CSF and GM-CSF
    • Antiviral cell-based assays for measuring the potency of interferons (IFN-α, IFN-β)
  • Assays for monoclonal antibodies
    • Mode of action (MOA) assays: ADCC, CDC, ADCP, apoptosis
    • Reporter assays
    • Binding assays
    • Potency assays
    • Competitive assays
    • Neutralization assays
  • Assays for antibody-drug conjugates (ADCs) and bispecific antibodies
  • Assays for immune checkpoint antibodies
  • Immunogenicity testing
    • Anti-drug antibody (ADA) assays: binding and neutralizing antibodies
    • Dendritic cell maturation assays
    • T-cell proliferation assays
    • Multiplex cytokine analysis by flow cytometry
  • Assay for toxins

Assay Readouts

  • Absorbance
  • Fluorescence
  • Time-resolved fluorescence
  • Luminescence
  • Flow cytometry
  • AlphaLISA®

Statistical Evaluations

  • Parallel line analysis
  • Four-parameter fit
  • Five-parameter fit
  • Equivalence test
  • EC50 determination

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Bioassays for Checkpoint Inhibitors

Reporter-gene bioassays present a reliable method to determine the responses of immunotherapies. Read our Eureka blog to learn more about the bioassays that can be used for checkpoint inhibitor therapies.

Bioassay Lab Expansion in Germany

Due to the increasing needs of pharmaceutical and biotech companies, we are expanding our lab capacities for bioactivity testing at our Erkrath, Germany site. The new laboratory in Germany will offer 450 m² of lab space designed to meet the special requirements of bioactivity testing.