mRNA/saRNA Process Development With PATFix Analytical Platform

Recent years have witnessed an unprecedented increase in development of mRNA-based vaccines and other mRNA-based therapeutics. The process of mRNA production is compared to production of traditional vaccines relatively simple and allows to produce large amount of therapeutic within a few days. Process usually consists of in vitro transcription reaction (IVT), followed by chromatographic purification of mRNA molecule (Fig. 1). Process needs to be coulpled with effective process analytical technology (PAT) at each step in order to achieve the highest product purity.