CMC Development of Peptides, A Case Study

An effective CMC strategy for any peptide API should include risk mitigation approaches suitable for the intended clinical or commercial phase. The development and technology transfer of a Peptide API process (e.g. Lanreotide) will be presented as a case study in tailoring projects to specific regulatory routes or applications.

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Jyothi Thundimadathil

Associate Director, CMC

Jyothi Thundimadathil, Ph.D is an Associate Director of Technical Operations and CMC Development at Bachem Americas, focusing primarily on NCE pipeline support of peptides and related molecules.  He has more than 20 years of experience in peptide chemistry, previously serving in different organizations in different roles including R&D, GMP development, marketing and CMC development. He has a PhD in Applied Chemistry from CUSAT/National Chemical Laboratory (India) and pursued postdoctoral research at Ben Gurion University (Israel), IUPUI (USA) and Purdue University (USA). He has published more than 40 papers, including book chapters and patents.

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