Continuous Revolutions : Distrupting the Pharmaceutical Manufacturing paradigm
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Unfortunately, both the cost and supply gaps of medicine are increasing. There are on average 200 active drug shortages nationally each year. Lengthy supply chains, limited numbers of manufacturers (commodity chemicals and drug product), and surges in demand are some of the more prominent causes of drug shortages. This lack of responsiveness, uncertainty, and diversity create pressure for drug suppliers, hospitals, and care givers to provide in time medication.
Active pharmaceutical ingredients (API) are world travelers with complex supply chains and long batch syntheses, meaning it can take months to manufacture and deliver the final drug product to the patient. This enormous space/time demand can result in reduced profits and inflated capital and operating expenditure.
With the era of blockbuster drugs apparently over and Pharmaceutical companies racing to the bottom of the pricing market in recent times, a paradigm shift towards continuous manufacturing may provide the answer. The benefits of flow chemistry in the synthesis of API have now been successfully demonstrated on a number of occasions. Likewise, many Drug Product unit operations are currently conducted in a continuous manner. The present challenge is now the implementation of an end-to-end manufacturing strategy that can allow these methodologies to work in concert, in a streamlined manner that enables drug substance and drug product production in one manufacturing platform.
Through the lifetime of the Pharmacy on Demand (POD) initiative, researchers have worked toward addressing these chemical and economic inefficiencies associated with “typical” large-scale batch pharmaceutical manufacturing. Substantial advances in complex reaction telescoping, real time formulation, reaction engineering and pumping technologies have enabled the design, construction and implementation of a compact and reconfigurable platform. Tight control of process inputs and the implementation of in-line process analytical technologies enabled high volumes of APIs (Atropine, Diphenhydramine, Ciprofloxacin, Diazepam, Doxycycline, and Lidocaine to name but a few) to be manufactured in hours and not days.
ABOUT THE PRESENTER
Dr Luke Rogers is currently the director of Chemical Synthesis for On Demand Pharmaceuticals working to commercialise their Pharmacy on Demand platform. He received his degree in Medicinal Chemistry from Trinity College Dublin. He also completed his Ph.D research in Trinity College on the synthesis and biomedical applications of Tetrapyrroles. After a stint within the Merck Manufacturing Division, working on a large scale GMP flow chemistry process step, he transitioned to MIT to lead efforts on multiple iterations of the Pharmacy on Demand project within the Department of Chemical Engineering. This work involved the development, optimisation, and integration of miniaturised continuous manufacturing processes for the production of Active Pharmaceutical Ingredients. After the successful demonstration of the manufacturing capabilities of such systems, he then transitioned to his current role where he is helping lead efforts towards a regulatory submission of a new manufacturing process for Ciprofloxacin on the Pharmacy on Demand platforms.