(202b) Design Space Development for the Final Recrystallization Process for Axitinib, a Complex Solvating API
AIChE Annual Meeting
2011
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Application of Quality by Design In API Process Development
Tuesday, October 18, 2011 - 8:55am to 9:20am
This example for axitinib, an oncology candidate recently submitted to the FDA, will examine the development of the final processing step (a seeded recrystallization) to deliver final drug substance to meet the desired solid form and quality specifications. The process development work for the recrystallization is a textbook case of the use of sequentially designed multivariate experiments coupled with first principles to establish a robust design space.