Advancements and challenges in next-generation mRNA vaccine manufacturing systems
Sang Hwan Seo, Man Ki Song
Abstract
The coronavirus disease 2019 pandemic has accelerated the global adoption and development of messenger RNA (mRNA) vaccine technology. While traditional manufacturing approaches rely on centralized and batch-based processes that are limited in scalability and accessibility, recent innovations in modular, decentralized, and continuous-flow production systems offer promising alternatives. This review summarizes the evolution of mRNA manufacturing, examines technological advances such as BioNTech's BioNTainer and Quantoom's Ntensify, and critically evaluates persistent barriers including raw material supply, regulatory compliance, sustainability, and cold-chain requirements. The implementation of artificial intelligence, thermostable formulations, and self-amplifying mRNA technologies are discussed as future directions. Collectively, these innovations offer a pathway to equitable, scalable, and rapid vaccine deployment in the context of both pandemics and routine immunization.