An automated modular assembly line for drugs in a miniaturized plant

The US healthcare system is facing unprecedented challenges with unaffordable drug prices and shortages of critical small-molecule drugs. More than 60% of these shortages are due to quality issues, most of which stem from the ‘step-by-step, batch’ manufacturing process that pervades the industry. As a paradigm-shifting approach, we report here a fully automated, end-to-end, integrated continuous manufacturing (ICM) process for a small-molecule generic medication with built-in quality assurance. The entire ICM process has a 30.7 m2 modular footprint and a total residence time of < 24 h, with a throughput up to 4,800 tablets/h, or 40.3 × 106 tablets/year. The commercialization of this innovative ICM process will lead to a more efficient and sustainable manufacturing sector, and could significantly improve the affordability and accessibility of pharmaceuticals on a global scale.