Enhancing Safety and Efficacy of mRNA-Based Therapeutics
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Codex® HiCap RNA Polymerase addresses challenges to drive advancement in IVT
Recent advancements in our understanding of RNA biology have catapulted mRNA to the forefront of therapeutic development. However, rapid maturation of mRNA technology is also straining the industry, and scrutiny from regulators is increasing to ensure the safety of these therapeutics.
During IVT, unwanted immunogenic byproducts can be produced, including double-stranded RNA (dsRNA). Given the potential efficacy and safety complications that can be introduced through excessive dsRNA content in mRNA batches, care must be taken to monitor for and remove this impurity.
While adequate post-IVT purification methods exist, these additional purification steps are expensive, time consuming, reduce final mRNA yield, increase batch-to-batch variability, and present scaling challenges. Therefore, the most effective strategy to deal with dsRNA is to minimize its formation in the first place.
This whitepaper discusses challenges associated with dsRNA in safety of mRNA therapeutics, and presents data demonstrating that Codex® HiCap RNA Polymerase produces exceptional yields of mRNA transcripts with significantly reduced dsRNA byproducts.