Scale-Up and Commercialization of Spray-Dried Amorphous Solid Dispersions

Spray drying is a preferred process for manufacturing amorphous solid dispersions to provide oral bioavailability enhancement for low solubility small molecules, which represent approximately 70% of the new chemical entity pipeline. A robust, efficient scale-up process that ensures critical-to-quality attributes (CQAs) are maintained is crucial to the commercial viability of these molecules.  This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges is presented along with methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale.