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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