2025 AIChE Annual Meeting

(664a) Development and Scale-up of a Biphasic Batch Isolation for a Pharmaceutical Intermediate

Authors

Alexander Hesketh, Rowan University
Steven Guinness, Pfizer Inc.
Kevin Girard, Bristol-Myers Squibb Company
Vaclav Svoboda, University of Strathclyde
A batch crystallization process was developed to isolate the intermediate of a three-step telescoped flow process from a biphasic product solution. The combination of laboratory isolations conducted up to a 20-liter scale coupled with computational mixing modeling and CFD software enabled the successful scale-up of this isolation. Performance at the laboratory, pilot, and commercial manufacturing scales will be discussed

Laboratory scale filtrations and subsequent characterization of filtration rates and cake compressibility led to an optimized fast-filtering filtration process. Emphasis was placed on developing an efficient filtration and washes that met desired product quality across manufacturing scales.

To better understand drying rates, a load cell was introduced into a vacuum oven to enable collection of drying data. These drying curves were then used to optimize the drying process in terms of both temperature and time. The combination of these approaches led to a robust process that consistently produced uniform solids that met the desired output parameters.