CMC Strategy Workshop Archives - Pharma Crystallization Summit

Dr. Qi Gao, J-Star Research

wpadm — Mon, 26 Sep 2022 22:58:39 +0000

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 Crystallography from University of Pittsburgh. After postdoctoral research in Biophysics and Structural Biology at MIT, she joined Bristol-Myers Squibb where she worked for 27 years on many molecules and processes of drug discovery and development. With over 35 years of experience in solid-state chemistry and materials science and 30 years of experience in Pharma R&D, she is an SME in crystallization, characterization, and properties of pharmaceuticals related to molecule, solid form and material, and in development of associated intellectual property and regulatory filings.

Workshop: CMC Development Strategies

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

wpadm — Sat, 16 Jul 2022 21:02:02 +0000

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 and amorphous. Each form displays unique solid-state properties that may profoundly influence bioavailability, stability, manufacturability and other performance characteristics of the drugs. Therefore, it is critical to conduct solid-state research and choose the right crystal form for development based on properties including crystallinity, hygroscopicity, solubility, stability, processability and flowability. This workshop will focus on in-silico & experimental approaches for solid form screen & selection, which includes the rational, methodology and workflow. A case study that illustrates the selection process will be presented.

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

wpadm — Sat, 16 Jul 2022 20:40:58 +0000

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 the industry to bring a product to the market faster, better, and cheaper, improve R&D efficiency, and increase manufacturing yield and profitability. The simulation-based approach can be used for process design, process scale-up, technology transfer, knowledge management, technoeconomic analysis, risk analysis, and regulatory submission for forward decision-making.

This workshop aims to provide a summary of the fundamentals, applications, benefits, and limitations of the use of mechanistic modelling for process scale-up and technology transfer for the development and manufacturing of chemical and pharmaceutical compounds. Case studies will be demonstrated to discuss the workflow, steps, challenges, and benefits for the life cycle of product/process development from ideation and R&D to manufacturing and regulatory submissions.

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Enabling Technologies for Tox/FIH Formulation

wpadm — Sat, 16 Jul 2022 20:23:36 +0000

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, safe use of the new drug candidate is of major concern. On the clinical side, the bio-pharmaceutical goal is to enable maximum exposure of animals to the drug during tox studies so that the dose ranges during FIH can be determined. Most new drug candidates nowadays have poor solubility. In this session we will review various technologies and approaches to improve solubilities. The inherent risks and implications for further development associated with each approach will also be discussed.

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