Design Space Development for the Final Recrystallization Process for Axitinib, a Complex Solvating API

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.