(558d) Process Modeling of a Continuous Drug Substance Manufacturing Process
- Conference: AIChE Annual Meeting
- Year: 2018
- Proceeding: 2018 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Wednesday, October 31, 2018 - 4:33pm-4:54pm
The unit operation connectivity (steady state mode) and effect of disturbances (process dynamic) on process robustness and challenges of process control to produce âin-rangeâ quality product could be simulated by process modeling. The simulations will be used for case studies and sensitivity analysis to define the sensitivity of the process to particular process parameters, and to investigate the effects of Critical Process Parameters (CPPs) on Critical Quality Attributes (CQAs).
Two steady-state and dynamic process simulation models were developed for an integrated drug substance continuous manufacturing process. The manufacturing process risk analyses were performed and effect of various CPPs on the process robustness and final CQAs were evaluated. With the dynamic model sensitivity analysis and disturbance effects were studied as part of the system dynamic investigation. The system dynamic case studies demonstrate the response of the system to a various disturbances of CPPs (temporal and spatial distributions of disturbances). As a result of this simulation development, process control and manufacturing stability risk analyses were performed and response of the process to different disturbances evaluated under different control strategies.