The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, emphasizing the need for smaller-scale, domestic manufacturing near raw material sources and healthcare facilities. This study presents the development of modular, continuous, end-to-end manufacturing platforms integrating reaction, distillation, crystallization, and drug product formulation to improve efficiency, reduce equipment footprint, and enhance adaptability. The approach was demonstrated through a case study on a high-potency oncology drug, Lomustine, showcasing the potential of a novel miniaturized pharmaceutical manufacturing system (MiniPharm platform) for intensified, distributed pharmaceutical production. This research aimed to offer a cost-effective alternative manufacturing process to enhance patient access and demonstrated the potential of modular manufacturing platforms to deliver lower-cost, high-quality oncology drugs. Lomustine was successfully synthesized and purified through a telescoped process that included two reaction steps, a continuous solvent-switch distillation (CSSD) and a combined cooling and antisolvent crystallization. The successful integration of upstream crystallization and drop-on-demand capsule printing was achieved. The modular end-to-end manufacturing platform was shown to produce an active pharmaceutical ingredient (API) sufficient to meet the estimated annual demand for Glioblastoma patients in the United States.
Akturk et al. (Tue,) studied this question.