Enhancing Safety And Efficacy Of mRNA-Based Therapeutics

The rapid advancement of mRNA technology has made it a leading candidate for therapeutic development, driven by our growing knowledge of RNA biology. However, this rapid progress also presents challenges, including increased regulatory scrutiny regarding safety.

A key concern is the formation of double-stranded RNA (dsRNA) during in vitro transcription (IVT). High levels of dsRNA in mRNA batches can negatively impact both the efficacy and safety of mRNA therapeutics, making its monitoring and removal crucial.

Current post-IVT purification methods for removing dsRNA, while effective, are costly, time-consuming, reduce mRNA yield, increase variability between batches, and are difficult to scale. Consequently, preventing dsRNA formation during IVT is the most effective approach.

This white paper explores the challenges posed by dsRNA in mRNA therapeutic safety and presents data showing that Codex® HiCap RNA Polymerase generates high mRNA yields while significantly minimizing dsRNA byproduct formation.