Product and Process Development: Role of Modeling and Simulation

Product and Process Development: Role of Modeling and Simulation

07/15/2020, 10:30 AM - 11:15 AM

Stage 1, Booth 1076, Exhibit Hall
Mechanistic models can describe process non-linearities and can be used to control the process and mitigate quality risks. Such models can be used as a digital sandbox for smart design and virtual product analysis and product development. The benefits can be categories as: A) Time and cost saving by minimizing experimental work for process and product development. B) Enabling numerous complex virtual DoE to define optimum process condition to predefine best condition for quality and efficiency. C) Reducing risk and facilitate tech transfer for scale up and CMOs management. D) Improving knowledge management and process transparency for executives, developers, and operators, and increasing enterprise profitability. E) Facilitating advanced process control, predictive performance, reducing batch-to-batch variability, and improving quality consistency. F) Improving asset utilization, improving logistic and supply chain management, and reducing regulatory issues.


  • Nima Yazdanpanah





  1. Objective 1. In this presentation examples of simulation application for drug substance and drug product processes will be discussed. 2. The role of modeling and simulation in pharmaceutical process scale up (lab to manufacturing), Tech transfer (from product owner to CMOs), model applications for regulatory submissions, techno-economical analysis and time and resources saving will be demonstrated. 3. Audience will learn about how to utilize process simulation and modeling for developing a digital twin for process and product development.

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