(224h) Design and Optimization of the Crystallization Process for Isolation and Purification of a Sterol Product

Crystallization processes play a crucial role in the biotech industry for isolating and purifying products. In this study, we address design considerations for developing a scalable one-step antisolvent and cooling crystallization process to selectively isolate and purify a sterol product with a desired crystal morphology. Response surface methodology (RSM) was employed to design experiments, model the process, and conduct multi-objective optimization aimed at maximizing both product yield and purity by adjusting the crystallization parameters like solvent type, antisolvent amount and addition rate, and final crystallization temperature. RSM predicted a maximum product yield of 89.9% and a purity of 87.5% under the optimized crystallization conditions. The confirmation experiment showed that the predicted results for product yield and purity can be achieved with relative errors of 6.1% and 1.6%, respectively, highlighting RSM’s effectiveness in optimizing crystallization parameters.