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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 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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