2024 Process Development Symposium
Capitalizing on Pilot Scale for a Mature Process Technology Scale-up
This presentation will focus on one such challenging scale-up that was defined by a mismatch of the copolymer resin process between the plant sections of reaction and isolation. The polymerization reaction required unique pH conditions for a part of the reaction. This limited the polymerization step by restricting the addition rate of other raw materials. The isolation section must take the output of the reaction section and requires fast monomer incorporation under unique pH conditions to move forward in stable operation. Pilot scale explorations deliberately investigated the key reaction parameters at the extreme conditions. Resulting materials underwent comprehensive product performance testing and various analytical characterizations. The outcomes were applied to devise optimal reaction operation regime and a detailed manufacturing scale-up package. When the very first scale-up production runs were conducted, the plant achieved safe and stable operation for the entire duration and produced impressively high yields of the finished product.