Pharmaceutical Process Development in the Age of Automation and AI

Abstract:   Advances in biology, especially in human genetics, are ushering in an exciting era for medicine and drug discovery. With these advances, pharmaceutical companies are able to more quickly discover new, and often more complex, compounds for treating diseases. While this is certainly good for pharmaceutical companies and for those in facing serious untreated illnesses, it also presents a challenge for process development departments, which now must keep pace with increasing molecular-complexity and shorter development windows. In this presentation, I argue that these demands will force process development departments to think differently, and in particular, integrate automation and AI into their development workflows. Using of two concrete examples—chemical reaction optimization and crystallization control—I will further describes what process development might look like in the age of automation and AI, and how the role of process development scientists and engineers may change, but remain just as crucial.