Pharmaceutical development is an overly complex process and there are many challenges along the way that rely on novel analytical approaches to provide scientific understanding, problem solving and quality control of the pharmaceutical product. Antibody drug conjugates (ADCs) are a novel modality that can selectively bind to the target cell and release the potent drug in situ for effective cell killing with minimized off-target toxicity. Since ADCs consist of both a small molecule (the potent drug) and the biological compound (monoclonal antibody), the characterization of ADCs is extremely challenging due to the size and structure complexity. Likewise, analytical characterization of other bioconjugates such as pegylated proteins, siRNA conjugates and vaccine conjugates is facing the same level of challenges. In this session, the advancement of using various analytical techniques to conduct the characterization of the ADCs and other bioconjugates will be discussed by well accomplished researchers in the field, including the critical quality attributes and the expectations of the agencies around the world.
