(336e) Distributed Pharmaceutical Manufacturing: The Quest for Pharmacy on Demand

Most generic pharmaceuticals sold in the United States of America are synthesized or formulated overseas, which leaves them vulnerable to supply chain disruptions. The World Health Organization (WHO) considers many of these generic pharmaceuticals to be essential for modern medicine. However, due to aging infrastructure and consolidated batch manufacturing processes, many of these generic pharmaceuticals appear on the FDA’s drug shortage list on a regular basis. In particular, injectable drugs are prone to shortages and currently represent 109 of the 172 drugs on the shortage list.

As a result, we have developed a miniaturized technology platform for the synthesis, purification, and formulation of generic pharmaceuticals. The Pharmacy on Demand (PoD)â„¢ platform enables domestic end-to-end manufacturing of the pharmaceutical supply chain from raw starting materials to formulated drug products, such as oral solid dosages or sterile injectables. By incorporating process analytical technology (PAT), flow chemistry, and automation into modular devices, a range of batch, semi-batch, and continuous processes can be conducted and scaled in an agile fashion depending on shifting market demands. The PoD platform is ideally suited for deployment using a distributed network of local or mobile manufacturing facilities to ensure a stable supply of quality medicines in both major population centers and disaster areas. By enabling cost-effective small-scale manufacturing, the PoD platform can replace aging centralized manufacturing facilities with a network of compact modern facilities to increase the reliability and responsiveness of the pharmaceutical supply chain.