3) Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission Archives - Pharma Crystallization Summit https://www.jstar-research.com/2022pcs/category/pcs2022/cmc-strategy-workshop/pcs2022cmc-03/ Conferences on pharmaceutical crystallization summit Sat, 27 Aug 2022 01:52:01 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.3 https://www.jstar-research.com/2022pcs/wp-content/uploads/2022/05/cropped-PCS-Icon-35-CC-32x32.png 3) Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission Archives - Pharma Crystallization Summit https://www.jstar-research.com/2022pcs/category/pcs2022/cmc-strategy-workshop/pcs2022cmc-03/ 32 32 Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission https://www.jstar-research.com/2022pcs/2022/07/16/simulation-aided-process-product-development-scale-up-tech-transfer-and-regulatory/ https://www.jstar-research.com/2022pcs/2022/07/16/simulation-aided-process-product-development-scale-up-tech-transfer-and-regulatory/#respond Sat, 16 Jul 2022 20:40:58 +0000 https://www.jstar-research.com/2022pcs/?p=2033 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 […]

The post Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission appeared first on Pharma Crystallization Summit.

]]>
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.

The post Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission appeared first on Pharma Crystallization Summit.

]]>
https://www.jstar-research.com/2022pcs/2022/07/16/simulation-aided-process-product-development-scale-up-tech-transfer-and-regulatory/feed/ 0