RNA-Based vaccine manufacturing: infrastructure, regulations, and global implications

Abstract

RNA-based vaccines have emerged as a powerful tool in the fight against infectious diseases, including the recent COVID-19 pandemic. However, their successful production requires properly designed facilities for RNA synthesis, purification, and formulation. This review article explores the facility requirements, regulatory aspects, and global implications of specialized RNA vaccine production. It highlights the importance of Good Manufacturing Practice (GMP), equipment and technology in the production process, providing a critical analysis of collaborations, investments, and the establishment of RNA plants around the world. Finally, it addresses the challenges faced by low- and middle-income countries and the role of the "tripod" production model involving collaboration between university, industry, and government. Overall, this document clarifies the most relevant aspects of RNA-based vaccine manufacturing, emphasizing the need for quality, safety, and scalability to meet global health demands.