(670a) Overcoming Kinetic Hurdles to Select and Manufacture an API Crystal Form

Herein we describe the process development and crystal form selection of an API salt with limited solubility and crystallization kinetics. We leverage a suite of in silico and experimental tools to provide insights on lead form stability and an initial risk assessment. We highlight challenges in the isolation of this crystal form across multiple solvent systems. We show the stabilization of a crystal form with an orthogonal solvent to enable a robust crystallization process. Finally, we demonstrate the scale-up and manufacture of the selected API crystal form.