Dr. Gerard Capellades receives industry research grant in a new partnership with Eli Lilly

The control of a drug substance purity relies heavily on rejecting impurities during the crystallization process of the active pharmaceutical ingredient (API). However, the process of rejecting impurities is highly complex due to multiple impurity retention mechanisms, each requiring a different strategy to design around. Impurities can also poison crystal growth, significantly altering the process outcome such as reduced yield, nucleation of small particles presenting filtration problems, and oiling or reduced rejection due to build up of supersaturation.

To meet the increasing pace in pharmaceutical development, isolation and synthetic route development must now be done concurrently and locked relatively early to prevent significant redesign or comparability issues for clinical material. The proposed work will help to enhance pharmaceutical processing and ensure quality drug products.