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Cell-based neutralizing antibody assays (NAb) for the detection of anti-drug product neutralizing antibodies for safety and efficacy assessment of biologics
Cell-based neutralizing antibody assays are the regulatory authorities’ preferred method to detect the presence of neutralizing antibodies (NAbs) to the drug as they best mimic the mechanism by which the NAbs exert their effect in vivo. It is important to detect the presence of NAbs as they potentially can bind to a therapeutic drug product and may inhibit their biological activity 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 assay) will depend on knowledge of the biopharmaceutical’s mechanism of action and the approach to development derived from the potency assays. They must be target specific, highly reproducible, suffer from minimal 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 and conduct tailored assay development and ensure a scientifically sound method validation. For cell-based NAb assays, we take steps to ensure the assay suitably determines the presence of neutralizing antibodies with a high level of drug tolerance through the selection of a drug responsive cell line, choosing the endpoint readout, selecting the positive control NAb and optimization of assay parameters. Subsequent analysis of clinical and preclinical samples can also be performed utilizing various cell-based assay readouts, including cell proliferation, cell death, or an indirect ELISA.
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.