Continuous Manufacturing (CM) is undoubtedly a hot topic in the pharmaceutical industry, with most companies either evaluating CM, running pilot CM programs, or actively deploying CM for both new and existing products.

The intention of this presentation is to share some of the technical and operational challenges around pharmaceutical CM implementation, including initial justifications for going continuous, the impact of making the change to CM on process development, including the development of Control Strategy (including explaining current thinking around the Control Strategy complexity pyramid), and the role of PAT in this paradigm change.

Examples will be used from small molecule active pharmaceutical ingredient (API), and all three common drug product formulation types (direct compression, wet granulation and dry granulation).