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. Assays Readouts & Statistics 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, apoptosis Binding assays Potency assays Competitive assays Neutralization assays Immunogenicity testing Anti-drug antibody (ADA) assays: binding and neutralizing antibodies T-cell proliferation assays Multiplex cytokine analysis by flow cytometry Assay Readouts Absorbance Fluorescence Time-resolved fluorescence Luminescence Statisical Evaluations Parallel line analysis Four-parameter fit Five-parameter fit EC50 determination You may also be interested in... 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. Contamination and Impurity Testing Charles River offers multiple testing methods that allow for increased confidence in the results of a biosafety testing program. Biosimilar Testing Products and Services We deliver client-focused biosimilars development and manufacturing solutions. ADCC Reporter Bioassays Log into the Source℠ for a look at an ADCC reporter bioassay using FcγRIIIa F158 effector cells.
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, apoptosis Binding assays Potency assays Competitive assays Neutralization assays Immunogenicity testing Anti-drug antibody (ADA) assays: binding and neutralizing antibodies T-cell proliferation assays Multiplex cytokine analysis by flow cytometry
Assay Readouts Absorbance Fluorescence Time-resolved fluorescence Luminescence Statisical Evaluations Parallel line analysis Four-parameter fit Five-parameter fit EC50 determination
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.
Contamination and Impurity Testing Charles River offers multiple testing methods that allow for increased confidence in the results of a biosafety testing program.
Biosimilar Testing Products and Services We deliver client-focused biosimilars development and manufacturing solutions.
ADCC Reporter Bioassays Log into the Source℠ for a look at an ADCC reporter bioassay using FcγRIIIa F158 effector cells.