Continuous Production of Five Active Pharmaceutical Ingredients in Flexible Plug-and-Play Modules: A Demonstration Campaign

TLDR

Traditional pharmaceutical manufacturing relies on a complex supply chain that is vulnerable to demand spikes and interruptions, while continuous production in compact modules offers a potential solution for on‑demand drug manufacturing with shorter lead times. The study demonstrates the Pharmacy on Demand initiative’s ability to manufacture multiple drug substances end‑to‑end in reconfigurable devices within industrial constraints and a tight time frame. Refrigerator‑sized modules were built for synthesis, isolation, and formulation of multiple drugs, aiming for high throughput and tablet production. The modules successfully produced USP‑compliant tablets of diazepam, diphenhydramine hydrochloride, and ciprofloxacin hydrochloride, and liquid formulations of lidocaine hydrochloride and atropine sulfate.

Abstract

Traditional pharmaceutical manufacturing is based on a complex supply chain that is vulnerable to spikes in demand and interruptions. Continuous pharmaceutical production in compact modules is a potential solution that allows for drug manufacturing when and where it is needed with significantly shorter lead times. As part of the Pharmacy on Demand (PoD) initiative, we demonstrate the potential for end-to-end manufacturing of multiple drug substances in reconfigurable devices, under common industrial constraints, and within a challenging manufacturing time frame. A new set of refrigerator-sized modules was constructed for the synthesis, isolation, and formulation of several drugs, with focus on achieving high manufacturing throughputs, and allowing for the production of pharmaceutical tablets. Their operation is demonstrated with the synthesis and formulation of USP-compliant tablets of diazepam, diphenhydramine hydrochloride, and ciprofloxacin hydrochloride, as well as liquid formulations of lidocaine hydrochloride and atropine sulfate.