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.

• Daly AM¹
• Hardiman S²
• Hogan D¹
• Morris G³
• Moylan R⁴
• O'Donovan B¹
• Power E⁵
• Phillips P⁶
• Robinson S⁷
• Roth PMC⁸
• Smyth M⁹
• Magner E^10,11
• Arthur A¹¹
• McGlacken GP^11,12
• Baumann M^11,12
• Maguire AR^11,12,13

•   ¹Pfizer Ringaskiddy, Co. Cork P43 X336, Ireland
• ²Arran Chemical Company, Monksland Industrial Estate, Monksland, Athlone, Co. Roscommon N37 DN24, Ireland
• ³APC Ltd., Building 11, Cherrywood Business Park, Loughlinstown, Co. Dublin D18 DH50, Ireland
• ⁴ Eli Lilly, Dunderrow, Kinsale, Co. Cork P17 NY71, Ireland
• ⁵SK Biotek, Swords Watery Lane, Swords, Co. Dublin K67 AY91, Ireland
• ⁶MSD Ballydine, Ballydine, Kilsheelan Clonmel, Co. Tipperary, E91 V091, Ireland
• ⁷J&J Innovative Medicines Little Island Industrial Estate, Little Island, Co. Cork T45 P663, Ireland
• ⁸Willy A. Bachofen AG Switzerland, Junkermattstrasse 11, Postfach 944, Muttenz 1 CH-4132, Switzerland
• ⁹Almac Sciences, Almac House, 20 Seagoe Industrial Estate, Craigavon BT63 5QD, Northern Ireland
• ¹⁰Department of Chemical Sciences, Bernal Institute, University of Limerick, Limerick V94 T9PX, Ireland
• ¹¹SSPC, The Research Ireland Centre for Pharmaceuticals Bernal Institute, University of Limerick, Limerick V94 T9PX, Ireland
• ¹²School of Chemistry, University College Cork, College Road, Cork T12 YN60, Ireland
• ¹³School of Pharmacy, University College Cork, College Road, Cork T12 YN60, Ireland

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