Quality assessment of bioanalytical quantification of monoclonal antibody drugs.

ABSTRACT

Monoclonal antibody biotherapeutics are developed to bind to a specific target to affect the target's biological effect. Reliable measurements of monoclonal antibodies in biological fluids using ligand-binding assays are vital for understanding the pharmacokinetic and pharmacodynamic relationships for efficacy/safety evaluations and dose-regimen selection. The method should be properly characterized and demonstrate adequate assay performance to generate credible data for the right decision making at each specific stage, with considerations on the constraints of timeline, reagent availability and assay caveats. Quality assessment of the assay performance should be based on whether the method is 'fit-for-use' to meet the objectives of the study. The basic industrial requirements and recent trends in method and data quality of ligand-binding assays for drug exposure studies at various development stages are discussed.