Bioanalytical interferences in immunoassays for antibody biotherapeutics

“Assays rarely fully reflect their intended use; knowing the performance boundaries of assays early represents an important approach to effectively managing their use during drug development.” The measurement of large biological analytes such as antibodies typically requires the use of ligand-binding assays, usually in immunoassay formats such as ELISA, radio-immunoprecipitation, electrochemiluminescence or surface-plasmon resonance. These employ at least one antibody or nonantibody protein (ligand-binding protein or ligand receptor), binding reagents that possess some degree of specificity for the analyte within the sample. For details on immunoassay formats for pharmacokinetic (PK) serum concentration measurements or antidrug antibody (ADA) detection, the reader...