(418c) Model-Aided Development for a Continuous Amide Bond Formation in a Drug Substance Manufacturing Process
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Tuesday, October 31, 2017 - 3:59pm-4:21pm
A case study is presented here that demonstrates the use of NMR reaction monitoring (ReactNMR), to gather high-value reaction data in batch mode for kinetic parameter estimation. The model describes the amide bond formation between an aniline and a mixed anhydride. The kinetic model was then employed to describe a continuous process that includes a plug flow reactor (PFR), a delay coil, two mixed-suspension, mixed-product-removal (MSMPR) crystallizers in series, and a filter/dissolution vessel. The resulting model was used to enable risk assessment, test failure modes, and build decision trees for use in the event of a process upset at manufacturing scale.