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Category : CMC Strategy Workshop

Dr. Qi Gao, J-Star Research

Dr. Qi Gao is a Distinguished Research Fellow of J-Star Research. She received a B.S. degree in Chemical Engineering and Materials Science from Tsinghua University and a Ph.D. in...

Combined In-Silico & Experimental Approach for Solid Form Screen & Selection

By Drs. Yuriy Abramov and Shanming Kuang, Center for Pharma Crystallization, J-Star Research Small molecule drug candidates tend to have different solid forms, including anhydrate, hydrate, solvate, salt, cocrystal...

Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission

By Dr. Nima Yazdanpanah, Consultant, Procegence Mechanistic modelling and process simulation, based on first-principle analysis, is a well-practiced tool in the chemical industry. The diverse applications have been enabled...

Enabling Technologies for Tox/FIH Formulation

By Dr. San Kiang, J-Star Research / Porton The business goal of most CMC development is to reach FIH as fast as possible. However, before IND or Phase 1,...

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