COMPETITIVE LIGAND BINDING ASSAY FOR DETECTING NEUTRALIZING ANTIBODIES

摘要

An immunogenicity assay for detecting the presence of a neutralizing antibody against a biotherapeutic protein administered to a patient in need of the biotherapeutic protein, comprising: (a) obtaining a sample from the patient; (b) incubating the sample in the presence of a capture reagent; And (c) adding a detection reagent, wherein the reduced signal compared to the control sample is indicative of the presence of a neutralizing antibody to the biotherapeutic agent.