Research Progress on the Stability of mRNA Drugs

mRNA drugs have the potential in disease prevention and treatment, but stability issues remain the main barrier to their widespread application. Based on the underlying chemical structure principles of mRNA drugs, this article provided a detailed introduction to the impact of the chemical structure of mRNA, 5’ cap, untranslated region, open reading frame(ORF), and poly(A) tail on stability, and suggested improving mRNA stability through optimized sequence design and the use of modified nucleosides. It was discussed that the composition of the mainstream lipid nanoparticle(LNP) delivery system for mRNA drugs, and its stability issues in production, storage, and transportation, and proposes measures to optimize LNP design and manufacturing processes to enhance stability. It was presented that methods for assessing the stability of mRNA drugs, quality control methods for mRNA drugs and regulations were also discussed.