Roles of mechanistic, data-driven, and hybrid modeling approaches for pharmaceutical process design and operation

This work presents a bird’s eye view depicting current trends in the pharmaceutical industry and the role of mathematical modeling in process design and operation within the framework of quality by design for a general readership in the field of chemical engineering. The paper outlines the vectors of change that are moving the pharmaceutical industry toward adopting new trends. The role of mathematical modeling is fundamental in accompanying the change taking place. A brief overview of model classification from a regulatory versus engineering point of view and recent progress in modeling in different pharmaceutical manufacturing subfields is illustrated. The short review concludes with important points to consider for maximizing the benefit of modeling in the pharmaceutical manufacturing field.