Analytical tools for antibody-drug conjugates: From in vitro to in vivo

Over the last decade, the biopharmaceutical market has witnessed a new wave of development in antibody-drug conjugates (ADCs) due to their high efficacy in cancer treatment. To date, thirteen U.S. Food and Drug Administration approved ADCs are available for clinical use. ADC development is dependent on analytical tools for comprehensively characterizing ADCs, from their biochemical attributes (such as drug-to-antibody ratio and conjugation sites) to their in vivo dynamics. This review will provide a general overview of ADC characterization from in vitro tests to in vivo dynamics. Recent advances in analytical techniques are helping us to better understand and optimize the quality, safety, and efficacy of ADCs. The advantages and limitations of these approaches will be described, and the challenges and potential opportunities for future ADC characterization will be discussed. The review will provide insights for the development of ADC analytical approaches, in turn facilitating the development of ADC drugs. (c) 2022 Elsevier B.V. All rights reserved.