Shankar Swaminathan, PhD

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

Speaker

Shankar Swaminathan, Ph.D. is a CMC and Drug Product Development leader with more than 15 years of experience spanning cell therapy, synthetic, and complex small molecule modalities. He currently serves as a Team Lead in Drug Product Development at the Astellas Institute for Regenerative Medicine, where he drives end to end CMC strategy, formulation, process development, tech transfer, and GMP readiness for multiple clinical stage cell therapy programs. Shankar brings deep expertise in phase appropriate CMC development for cell therapies, steering programs from early development through pivotal clinical execution. This includes optimizing cryogenic handling, refining critical quality attributes, establishing scalable processes, and ensuring GMP readiness across multiple batches to support regulatory milestones and commercialization pathways.Dr. Swaminathan is recognized for advancing innovative solutions in cryopreservation, particulate control, sterile manufacturing, and next generation delivery systems. Prior to Astellas, he held scientific leadership roles at Supernus Pharmaceuticals and Perrigo, contributing to NDA/ANDA submissions, clinical supply delivery, and commercialization strategies across a broad range of dosage forms. He has authored 20+ peer reviewed publications, multiple patent applications, and has been regularly invited to speak at industry conferences