Challenges in developing bioanalytical assays for characterization of antibody-drug conjugates.

With more than 34 targets being investigated and nearly 20 clinical trials at various phases of development, antibody-drug conjugates (ADCs) hold a lot of promise for improving oncological malignancy therapy. This therapeutic strategy designed to specifically or preferentially deliver a cytotoxic agent to tumor cells through conjugation to a monoclonal antibody is not new. Although this approach is relatively simple conceptually, the history of ADCs clearly attests to the high degree of complexity in their development. Each component of an ADC is important to achieve efficacy with minimal toxicity, and the ability to monitor this multicomponent therapeutic entity is deemed to be critical for their successful optimization. In this article we review the different bioanalytical strategies that have been implemented to characterize various ADCs and discuss the challenges and issues associated with these approaches.