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Sanjay Nilapwar, Ph.D.
Senior Research Investigator (Purification Development) at Incyte Corporation


Dr. Sanjay Nilapwar currently works as Senior Research Investigator and looks after purification process development and related CMC aspects of biologics portfolio of Incyte Corporation, Wilmington. He is part of platform large molecule CMC development team and is responsible for transitioning of mAb and bispecifics from candidate drug to development, manufacturing and commercialization stage, encompassing early to late state process purification development, process characterization/validation, technology transfer and related regulatory aspects including filing IND/IMPDs. Prior to working with Incyte, he has worked in Medimmune LLC, where he was involved with process development novel biological, such as bispecific mAbs and site-specific conjugates, stability and analytical assay development and was instrumental in setting up large scale conjugate purification lab within Medimmune. He started working on protein purification at Piramal Lifescience by process development for range of therapeutic biologics such as mAbs, conjugates and radiolabeled chelates for Targeted therapies. He has more than 15 years of experience in mAbs/conjugates purification development and has published 10 papers and written couple of book chapters. He regularly speaks at bioprocessing conferences and chairs conference session. Dr. Nilapwar has earned his PhD in Molecular Biology and Biophysics from UCL, London on an Astra-Zeneca sponsored studentship and M. Pharm in Pharmaceutical Chemistry from Mumbai University on Government of India sponsored Junior Research Fellowship. He currently serves as reviewer for half a dozen journals and is on editorial/review board for Journals, ADC Review, British Journal of Pharmaceutical Research and Bioprocess International.

Agenda Sessions

  • Monoclonal Antibody Disulfide Bond Reduction In Clinical Manufacturing and Mitigation using Copper Sulfate: A Case Study