Good Manufacturing Practices and Upscaling of mRNA Vaccine Production

The rapid development and production of mRNA vaccines proved to be a pivotal response to the urgent global demand during the COVID-19 pandemic. This chapter gives an overview of mRNA vaccine mass production, emphasizing good manufacturing practices (GMPs) compliance and challenges. We are detailing here all the steps of template DNA and IVT mRNA production and the multiple purification processes. This chapter also summarizes the synthesis of lipid nanoparticles, with a focus on upscaling to meet industrial standards. Finally, the chapter contains the methods for quantifying and qualifying mRNA at an industrial level.