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Continuous API manufacturing in pharma – Where are we today and where will we be in ten years?

corresponding

C. OLIVER KAPPE
Scientific Director, Center for Continuous Flow Synthesis and Processing (CC FLOW), Research Center Pharmaceutical Engineering Gmbh, Austria

Drivers for the pharmaceutical industry to move API production from batch to continuous are commonly seen as being much weaker than for the commodity chemical industry. The production volumes of APIs are considerably less than those of bulk chemicals and product lifecycles are often short. Furthermore, most APIs are significantly more complex than commodity chemicals and their production usually requires many synthetic steps in addition to multiple cycles of isolation and purification. The complexity and diversity of these molecules, and the consequent multifaceted and diverse process conditions required for their synthesis and isolation, generally demand flexible, multipurpose reaction vessels for their production. Stirred tank-reactors are easy to handle and can be employed for a range of different operations (“multipurpose”). However, despite their long history and prevalence in fine chemical and pharmaceutical manufacturing, batch-type reactors have some severe, well-recognized limitations. Most importantly, chemical reactions which release large amounts of energy or proceed via unstable, highly toxic or explosive intermediates are difficult or impossible to imple ...