Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients that would better serve the advanced processing needs and objectives.

The intensifying focus on excipients, as industry and regulators explore together how to take pharmaceutical manufacturing and control to the next level, was evident throughout the third FDA/Product Quality Research Institute Conference on “advancing product quality,” held in Rockville, Maryland in late March.