Session: Bio and Pharmaceutical Formulation & Process Design

This session covers the formulation process development of both biologics and small molecule drug products. Papers are invited, but not limited to techniques involved in oral, parenteral, transmucosal and transdermal delivery systems. Topics of interest include best practices in early development formulation optimization (stability, manufacturability, and bioavailability) and scale-up to commercial manufacturing , innovative ways of reducing development cycle time, and interesting case studies that highlight the impact of good formulation and process design to solve challenging problems. Priority will be given to submissions that show scale-up experience and demonstrate Quality by Design principles for various solid and liquid dosage forms and processing methods.