The Pharmaceutical Drying Unit Operation: An Industry Perspective on Advancing the Science and Development Approach for Scale-Up and Technology Transfer

The drying unit operation is used extensively in the pharmaceutical industry, but often a lack of understanding of the impact of the drying process parameters on active pharmaceutical ingredient critical quality attributes can create challenges during development. A working group within the Enabling Technologies Consortium identified common challenges in pharmaceutical drying development, including material constraints for scale-up studies and transferring to different equipment types and sizes. This manuscript surveys current practices within the industry for drying development related to chemical and physical stability, drying kinetics, and powder properties and highlights common development gaps for improving drying development workflows within the industry. The ultimate goal is to encourage further fundamental research and technological advancements for improving the drying development workflow.