(328e) Multiscale Modeling of a Plug Flow Reactor for a Continuous Drug Substance Manufacturing Process
- Conference: AIChE Annual Meeting
- Year: 2018
- Proceeding: 2018 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Tuesday, October 30, 2018 - 1:58pm-2:20pm
In Quality by Design framework, mathematical models can be utilized at every stage of product development and manufacturing including risk management. Predictive models can aid process development by estimating the impact of process and equipment parameters, and material attributes (i.e., the model inputs) on product attributes (i.e., the model outputs) thereby providing a quantitative framework for assessing risk and evaluating risk mitigation approaches. The emerging technology, continuous manufacturing, is a potential driving force for the utilization of process modeling and simulation. Mechanistic model can describe process nonlinearities and can be used to control the process and mitigate quality risks. Process modeling and simulation and given that process design, integration, evaluation, scale up, and optimization can be performed for the overall process once individual process unit have been characterized mathematically using models.