(594b) Pharmacy-on-Demand: A Continuous Revolution in Pharmaceutical Manufacturing?

Rogers, L., Massachusetts Institute of Technology
Adamo, A., Massachusetts Institute of Technology
Behnam, M., Nuvera Fuel Cells
Chen, J., Massachusetts Institute of Technology
Jamison, T., Massachusetts Institute of Technology
Jensen, K. F., Massachusetts Institute of Technology
Myerson, A. S., Massachusetts Institute of Technology
Weeranoppanant, N., Massachusetts Institute of Technology
Wong, S. Y., Massachusetts Institute of Technology
Neurohr, C., Massachusetts Institute of Technology
Sayin, R., Purdue University
Hammersmith, G., Massachusetts Institute of Technology
Salz, C., MIT
Lin, H., Massachusetts Institute of Technology
Thomas, D., Massachusetts Institute of Technology
Briggs, N., EPSRC Centre for Innovative Manufacturing in Continuous Manufacturing and Crystallisation, University of Strathclyde
Unlike its counterparts in the petrochemical, food and drink industries; pharmaceutical manufacturing still applies a non-continuous or “batch-wise” approach. Thus, current pharmaceutical processes are ill-equipped to react to market forces or surges in demand due to humanitarian outbreaks. 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 has 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.

Pharmacy on Demand (POD) seeks to address these manufacturing inefficiencies through the use of a compact and reconfigurable platform, capable of multi-step syntheses for a catalogue of API. Substantial advances in complex reaction telescoping, real time formulation, reaction engineering and pumping technologies have enabled the design, construction and implementation of the platform. Tight control of process inputs and the implementation of in-line process analytical technologies enables high volumes of APIs (Atropine, Benadryl, Ciprofloxacin, Diazepam, Doxycycline, Lidocaine and Ibuprofen) to be manufactured over a three-week campaign period. This timeframe involved the synthesis, recrystallization and formulation of each API to their correct dosage form. These solid or liquid formulated Drug Products are produced to a standard that passes all USP specifications.