Dr Kumar Dhanasekharan | Senior Director and Head of Biologics Process and Analytical Development
Amicus Therapeutics Inc

Dr Kumar Dhanasekharan, Senior Director and Head of Biologics Process and Analytical Development, Amicus Therapeutics Inc

Dr. Dhanasekharan is Senior Director of Process and Analytical Development at Amicus Therapeutics responsible for late stage development and scale-up of biologics. He is currently heading the development for the lead enzyme replacement therapy program ATB200. Previously, he was responsible for process and analytical development at Cook Pharmica, a contract and development organization (CDMO) in Bloomington, Indiana. Previously, he was at Genzyme-Sanofi in various roles including process development, process engineering and was Associate Director of Process Sciences and Technology at Genzyme in Framingham, Massachusetts. He was responsible for continuous process improvements and process monitoring and Continued Process Verification (CPV) program in driving a science and risk-based strategy including improved control strategies, cell culture productivity and downstream recovery improvements. In a previous role, he led the implementation of Quality by Design (QbD) principles in development and successfully led a QbD based Lyophilization scale-up and tech. transfer project for approval. He also led efforts in viral risk mitigation which resulted in an invention and patent on a UV-C based viral inactivation device. He also provided technical leadership for several projects related to Consent Decree remediation.  Prior to joining Genzyme, Kumar led small-molecule process development focused on API crystallization at Bend Research Inc., Bend, OR. Prior to that he was group leader for consulting services at Fluent Inc. (Now ANSYS Inc.) with focus on both small-molecule and biologics development and manufacturing challenges across upstream, downstream, and Fill/ Finish operations. Kumar has a Ph.D. in Food Science from Rutgers University and a Bachelor's in Chemical Engineering from Indian Institute of Technology, Chennai, India. He has over 50 conference presentations and over 10 peer-reviewed publications.

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