The role of chemical engineering in process development and optimization.

This review focuses on the roles that chemical engineers can play in the development, scale-up and optimization of synthetic processes for the production of active pharmaceutical ingredients. This multidisciplinary endeavor involves close collaboration among chemists and chemical engineers, and, for successful products, involves bridging the R&D and manufacturing enterprises. Balancing these disparate elements in the face of ever-mounting competitive pressures to shorten development timelines and ever-tightening regulatory, safety and environmental constraints, has become a critical business objective for all pharmaceutical companies. The concept of focusing development resources on selected critical process features as a function of phase within the development cycle will be discussed. In addition, several examples of chemical engineering- focused process development and optimization will be presented.