(84d) Development of a Novel Platform Technology for Crystallization of Active Pharmaceutical Ingredients

The pharmaceutical industry is undergoing significant changes in operating paradigms with the time to market and cost being the primary drivers. The particle size of the active pharmaceutical ingredient has a profound effect on biopharmaceutical performance for low solubility compounds and can also affect formulation processability for compounds in all solubility classes. A key challenge in the industry is to streamline workflow to meet the appropriate particle size for each API. The purpose of developing a platform technology for crystallization of API is to standardize process development from laboratory to pilot plant and to achieve certainty on scale-up. Here, we describe a novel Platform technology for particle engineering expected to replace former methods for approximately 80% of new chemical synthetic products. Details of the conceptual approach, the process, and examples will be provided. Pilot plant (100 gallon) success on several products provide confidence for the utility of the technology at the manufacturing scale.