Dipkumar Jagani

Dipkumar Jagani is currently a regulatory CMC Lead at Astellas. In this role he is responsible for the regulatory strategy and execution for the CMC development of early-to-late-stage CMC product development as well as post-approval support for commercial products, primarily antibody-based biological products including antibody-drug conjugates (ADCs). Dipkumar has over 15 years of experience in the industry holding various roles within CMC development focusing on analytical development, stability study design and GMP operations. He has worked with several dosage forms, IV and subcutaneous formulations as well as supported device (single entity) development. Dipkumar holds a bachelor's degree in Biological Sciences, majoring in cell biology and genetics and a master's degree in biotechnology from the University of Maryland.