Charles River Biopharmaceutical Services (BPS) has the capability to perform a comprehensive array of both in vitro and in vivo bioassays for a variety of biologically active molecules. Bioassays are used to determine the potency or biological activity of a biopharmaceutical. They can be used to assess the potency of proteins, antibodies or hormones by comparing their effects on a culture of living cells or a test organism to those of a control preparation. Potency assays are conducted to determine the activity of the molecule and are regularly part of the regulatory submission and lot release. The concentration or potency of a substance is determined by measurement of the biological response that it produces. The data generated by bioassays are typically analyzed using biostatistical methods.
- Bioassays are critical for:
- Product development and manufacturing
- Ensuring continued quality, safety and efficacy of biopharmaceutical products
- Bioassays must be:
- Relevant (reflecting the mode of action of the biopharmaceutical)
- Reliable
- Standardized in regards to equipment, materials and procedures
- According to the European Pharmacopoeia (EP), in vivo assays should be replaced by in vitro assays or physico-chemical methods whenever possible.
- Several cell-based bioassays are specified in the EP, which are performed following a monograph.
- Bioassays should be cGMP-compliant.
Assay Types (In Vitro)
- Cell-based potency assays for EPO, PTH, G-CSF and GM-CSF, and other proteins
- Antiviral cell-based assays for measuring the potency of interferons (IFN-α, IFN-β)
- Reporter gene
- Luminescence
- Fluorescence
- Monoclonal antibodies
- Cytotoxicity
- Antibody-dependent cell-mediated cytotoxicity
- Complement-dependent cytotoxicity
- Cell proliferation
- Cell survival
- Competitive
Statistical Evaluation
- EC50 determination
- Four-parameter fit
- Five-parameter fit
- Parallel line analysis
For more information, please contact us at askcharlesriver@crl.com.
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bioassays, in vivo bioassays, in vitro bioassays, potency assays, cell-based bioassays, cGMP, monograph, Cytotoxicity, cell proliferation, Cell survival, EC50 determination, Four-parameter fit, Five-parameter fit, Parallel line analysis, interferons, IFN-α, IFN-β
Bioassays | Charles River Biopharmaceutical Services
Bioassays are used to determine the potency or biological activity of a biopharmaceutical. Charles River Biopharmaceutical Services performs a comprehensive array of in vitro and in vivo bioassays for a variety of biologically active molecules.