Process Development and Manufacturing of mRNA/LNP Products: the Catalent Experience

mRNA/Lipid Nanoparticle (LNP) technology has evolved rapidly over the last decade, significantly changed the vaccine and therapeutics landscape, and recently proven its technology potential with commercial successes in two COVID-19 vaccines. Catalent has contributed to the evolution of this exciting technology field since 2016, by helping clients to develop, manufacture, and test vaccines or drugs for cancer, infectious disease, or genome editing applications. In this presentation, we will share our process development and manufacturing experience in the workflow from DNA, mRNA, LNP, to fill finish. Unique challenges in developing and manufacturing this nascent technology will be covered. Outlook on further evolution of DNA and mRNA technology to increase product quality and reduce development time will be discussed. Challenges and opportunities in LNP processing and stabilization will be discussed.