Scaling up RNA manufacturing through adaptable downstream processing

Despite rapid advances in RNA-based vaccines and therapeutics, downstream processing remains a primary constraint on scalable, cost-effective manufacturing. In this commentary article, three researchers at the University of Sheffield discuss key downstream challenges across mRNA and self-amplifying RNA (saRNA), including purification, pre- and post-lipid-nanoparticle processing, as well as analytical limitations, and highlight adaptable, low-shear, digitally enabled platforms as critical enablers of robust RNA manufacturing at scale.