Integrated continuous cGMP platform for end-to-end mRNA manufacturing

mRNA has evolved from a niche research technology into a major therapeutic platform, with its impact clearly demonstrated during the COVID-19 pandemic. While mRNA vaccines achieved unprecedented development timelines and strong clinical outcomes, limitations in production capacity, supply chains, and batch scalability constrained global access as witnessed during the pandemic. As applications expand to personalized cancer vaccines, protein replacement therapies, and advanced immunomodulators, the need for agile and reliable manufacturing platforms is pressing. To address these limitations, a team of experts from academia and industry supported by regulatory specialists developed a fully integrated, end-to-end continuous platform for cGMP-compliant mRNA manufacturing, encompassing both a micro-factory (~25–50 mg/h) and a pilot plant (>1 g/h). The platform integrates mechanistic, data-driven, and hybrid models to optimize in vitro transcription, precipitation-based purification, tangential flow filtration, lipid nanoparticle formulation, and continuous lyophilization. Real-time monitoring of critical process parameters and quality attributes is incorporated throughout, enabling predictive process control and enhanced product consistency. By coupling modular, scalable operations with digital twin frameworks, the platform reduces reagent consumption, accelerates development timelines, and strengthens supply-chain resilience. Ultimately, this proof-of-concept work demonstrates that continuous, end-to-end mRNA manufacturing is feasible and can deliver high-quality therapeutics at flexible scales, providing a generalizable framework to expand global access to mRNA-based medicines and support rapid responses to emerging health challenges.

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