Abstract
Antibody-drug conjugates (ADCs) are a new class of biotherapeutics, consisting of a cytotoxic payload covalently bound to an antibody by a linker. Ligand-binding assay (LBA) and liquid chromatography-mass spectrometry (LC-MS) are the favored techniques for the analysis of ADCs in biomatrices. The goal of our review is to provide current strategies related to a series of bioanalytical assays for pharmacokinetics (PK) and anti-drug antibody (ADA) assessments. Furthermore, the strengths and limitations of LBA and LC-MS platforms are compared. Finally, potential factors that affect the performance of the developed assays are also provided. It is hoped that the review can provide valuable insights to bioanalytical scientists on the use of an integrated analytical strategy involving LBA and LC-MS for the bioanalysis of ADCs and related immunogenicity evaluation.