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BioProcess International
September 23-26, 2024
Hynes Convention CenterBoston, USA

Shankar Swaminathan, PhD
Team Lead, Drug Product Development, CMC-Tech Ops at Astellas Institute for Regenerative Medicine


Dr. Shankar Swaminathan is Team Lead, Drug Product Development at Astellas Institute of Regenerative Medicine leading drug product development and technical transfer activities for multiple pre-clinical cell therapy candidates. Shankar obtained his doctoral degree in pharmaceutics focusing on creating new polymer-based drug delivery formulations for cancer nanomedicine. Soon after his PhD, he joined the pharmaceutical industry to work on drug eluting long-acting combination products. He later went onto complete his post-doctoral training in ophthalmic drug product development at the College of Medicine at University of Tennessee health science center, where he focused on creating new treatment approaches for debilitating eye diseases. As a young investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Shankar led CMC activities for multiple products/INDs submitted for approvals to various agencies. He has about 15 years of combined industry and academic experience and has successfully overseen product development from early-stage discovery through late-stage submissions and validation. He is currently supporting multiple cell therapy projects, including immuno-oncology modality from development through GMP technical transfer and manufacturing. He is vastly experienced in aseptic drug product development, quality-by-design, advanced drug delivery, cryopreservation technology, CTM campaign execution and management, fill-finish, modified release solid orals, and ocular drug delivery. He is an editorial board member in Scientific Reports and serves as a reviewer for over 20 peer-reviewed journals. He has published 15+ peer reviewed publications, commentaries, and blogs

Agenda Sessions

  • Phase-Appropriate Manufacturing: Trial and Error...or Trial and Triumph?