(577f) Process Control Strategy for Synthetic Continuous Manufacturing
AIChE Annual Meeting
2019
2019 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Development of Pharmaceutical Process Control Strategies for Drug Substance Manufacture
Wednesday, November 13, 2019 - 5:15pm to 5:36pm
Continuous manufacturing enables a smaller manufacturing footprint, improved environmental sustainability, improved control strategy, and flexibility to meet changing demand among other benefits; however, the transition from batch to a continuous mode of operation can be resource intensive in terms of number of parameters that require evaluation for optimal process design and process characterization. These resource requirements can be reduced significantly by augmenting empirical design with integrated systems-based modeling.
A âVirtual Plant for Synthetic Continuous Manufacturingâ was developed on the grounds of a systems-based modelling platform. Model components were integrated to form the end-to-end process model, with which in silico studies (sensitivity analysis, uncertainty propagation, etc.) are performed to identify the key process parameters that will affect the critical quality attributes. Here we present the development and testing of an integrated advanced process control strategy enabled by the systems-based model. This approach is envisioned to support regulatory filings for CM processes. Development of a virtual plant for synthetic CM enables us to predict process performance and product quality in a real plant environment.