(373b) Model-Aided Development for a Mixed Anhydride Formation in a Drug Substance Manufacturing Process
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Tuesday, October 31, 2017 - 12:52pm-1:14pm
A case study is presented here that demonstrates the use of automated experimentation to gather high-value reaction data for kinetic parameter estimation of a six reaction step mechanism with nine components. The model was used to simulate kinetic and thermal profiles for varying addition strategies of a key reagent. The resulting model was used to define parameter targets and ensure process robustness in preparation for a successful registration stability campaign.