(665a) Impurity Rejection in Crystallization –Quantification and Mechanisms
AIChE Annual Meeting
2017 Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Innovations in Biopharmaceutical Discovery, Development, and Manufacturing
Thursday, November 2, 2017 - 8:00am to 8:22am
In Pharma industry, most of the impurity control in crystallization has traditionally been carried out by synthetic chemists who mainly rely on a before and after approach that is highly empirical in nature. Presented herein is the use of engineering principles to accurately quantify rejection of impurities throughout the crystallization. Various mechanisms of impurity rejection are identified and linked to thermodynamic and/or kinetic effects. Case studies from pharmaceutical development are presented that provide a clear understanding on the impurity purge mechanisms and how they are affected by process conditions. This work thus enables simple control measures to be introduced in the crystallization process that are capable of producing materials with targeted purity profile, whether that is for toxicity studies or for clinical trials.