Insights into Flow and Continuous Systems in Pharmaceutical Manufacturing: Challenges and Opportunities

Growth and development of the pharmaceutical sector in Ireland has been remarkable over a 50 year period starting as an API manufacturing hub with strong regulatory confidence gradually expanding to include a range of activities ranging from process R&D, formulation services, and other high-value elements of the pharmaceutical enterprise, while in parallel complementary expertise in bioprocessing and biotechnology has resulted in the sector being globally significant and integrated into global supply chains. The more significant change in API manufacture in recent years has been the introduction of continuous flow technology offering many advantages including safety, efficiency, and flexibility. Nevertheless, in such a highly regulated sector navigating the transformation from traditional large-scale batch manufacture to embedding flow technology is not trivial. The Irish landscape, comprising leading multinational API-producing sites, complemented by Contract Development and Manufacturing Organizations (CDMOs) and indigenous companies providing tailored services, has very successfully embraced embedding continuous flow technology for API and RSM manufacture at scale in partnership with the regulatory agencies. In this context, some aspects underpinning this transition are discussed as an informative commentary on the state-of-the-art for the use of flow in API/RSM manufacture.