Antibody-drug conjugates (ADCs) require multiple assays for analytical and bioanalytical characterization due to their heterogeneous and dynamic nature. These assays can help address questions from the drug-loading distribution following conjugation to exposure-response relationships after dosing in vivo. This review describes new assay technologies that have been developed for physiochemical characterization and determination of pharmacokinetic parameters of ADCs.
Alley SC, Anderson KE. Analytical and bioanalytical technologies for characterizing antibody-drug conjugates. Curr Opin Chem Biol. 2013 Apr 6. pii: S1367-5931(13)00052-5.