Cell-based anti-drug neutralizing antibody (NAb) assays for safety and efficacy assessment of biologics
Cell-based assays mimic the mechanism by which the neutralizing antibodies (NAbs) exert their effect in vivo and are the regulatory authorities’ preferred method to detect NAb presence. It is important to detect the presence of NAbs as they may potentially inhibit biological activity of the therapeutic drug product impacting safety and efficacy of the biopharmaceutical.
Cell-based neutralizing antibody assays can be difficult to develop as the selection of the most suitable assay type (indirect or direct) and format depends on thorough understanding of the drug’s mechanism of action. Each assay must be target specific, reproducible, minimally affected by matrix effects, and be able to detect the NAb in the presence of the therapeutic.
Experienced cell-based neutralizing antibody assay capabilities
Our experts, based in Good Laboratory Practice (GLP) compliant laboratories, evaluate each therapeutic, conduct tailored assay development and ensure that each assay is optimized to suitably determine the presence of NAb with maximum possible level of drug tolerance. Assay development and optimization are performed through careful selection of proper cell line, assay format, and positive control NAb, optimization of assay parameters, sample dilution or pretreatment, if necessary, and meticulous data processing and statistical analysis. Variety of assay formats can be implemented, including but not limited to Cell Proliferation, Viability, Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), Complement-Dependent Cytotoxicity (CDC), Cytopathic Effect Inhibition (CPE), Apoptosis, Ligand Stimulated Cell Signaling, Enzyme Activity, Reporter Gene Assays, Protein Secretion, Metabolic Activity, Stress and Mitochondrial Function. Detection readouts include Absorbance, Fluorescence, Luminescence, Chemiluminescence, or Flow Cytometry.
Through the intelligent and experienced application of cell-based neutralizing antibody assays, Intertek is the ideal partner for your biologic drug development or pharmacovigilance requirements for immunogenicity testing. Our immunogenicity experts, who are considered thought-leaders in the large molecule bioanalysis community, have worked on thousands of biologic drugs helping global clients understand the safety and efficacy of their products.
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