(505a) Development and Qualification of a Custom Continuous Blending System for Clinical Manufacturing

Merck has used Design Thinking to develop a custom continuous blending system for our Solid Dosage Pilot Plant that is capable of meeting the needs of many users across the Product Development functions, including capabilities and flexibility for both small-scale development and clinical manufacturing. This presentation will step through the design process on through qualification and implementation of the system including early data and experience from the system. The discussion will focus on sharing lessons learned throughout the process of designing and implementing this new technology.