Preparation of Synthetic mRNAs—Overview and Considerations

Abstract

Synthetic messenger RNAs (mRNAs) are a novel modality for vaccines and therapeutics. mRNA vaccines have been proven to be clinically efficacious and safe. The central advantage of the successful use of synthetic mRNA as a vaccine hinge on being able to rapidly manufacture the mRNA molecules. The synthetic mRNA is prepared in vitro via a cell-free enzymatic process. The aim of this chapter is to provide an overview of the enzymatic mRNA synthesis process and discuss the enzymatic components involved in the workflow. Furthermore, critical parameters that need to be considered for characterization of the synthetic mRNAs are also discussed.