End to End Continuous Manufacturing: Integration of Unit Operations

This chapter discusses the challenges and opportunities when fully integrating a continuous manufacturing (CM) process for pharmaceuticals from end to end. It provides a brief overview of the key unit operations in the process for completeness. The chapter also presents a realistic case study to support the discussion with real-life examples from pilot plant experiments. The chapter discusses the role of system dynamics and the role of process analytical technology (PAT) in the studied pilot plant. In addition, the chapter also briefly discusses the relation between PAT and process models to estimate unknown process variables for monitoring and automated control. Moreover, novel technologies that are currently under development are expected to further enhance CM of pharmaceuticals. The chapter further discusses examples of such future technologies. It ends with a chapter summary and discussion of benefits and challenges of CM of pharmaceuticals.