Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer

A brief introduction to the principles of lyophilization would be presented at AAPS Rapid Fire session. Attendees will learn about impact of "as is" lyophilization process on the quality of commercial products. It would be demonstrated that differences in heat transfer between laboratory and commercial dryers require alteration of lyophilization process to maintain the high-quality lyophilized products. Attendees will also learn that GMP low particulates conditions, resulting in increased product resistance as compared to laboratory made samples, create unique challenges in process transfer. It will be shown that one need to establish capability limits for the commercial freeze-dryer to enable the successful lyophilization process scale up. The recommendations for the successful lyophilization process transfer and scale up would be shared with the audience.