Fueled by the success of the messenger ribonucleic acid (mRNA)-based COVID-19 vaccines, RNA-based medicines are poised to revolutionize the pharmaceutical industry. These therapeutics have provided definitive proof of the therapeutic efficacy and safety of this new modality which has catalyzed interest and investment across the industry. This is leading to the development of RNA therapeutics beyond prophylactic vaccines and towards breakthrough treatments for cancer, rare diseases and more.
It is important to note that there are some unique challenges and risks in each step of the drug development process for this rapidly growing class of drugs, and success lies in considering the path to commercialization at the earliest stage possible. Each phase of mRNA-based therapeutic development consists of specific goals, steps, and end points. Learn the fundamentals of manufacturing mRNA-lipid nanoparticle (LNP) drug products from discovery through to commercialization.