Strategic manufacturing and versatile applications to expand the mRNA therapeutic frontier.

mRNA therapy has emerged as one of the most promising therapeutic approaches in recent years. In this study, we identified key technological challenges and issues and examined organizational requirements necessary to address them and drive the expansion of clinical development. Key technological challenges and issues for the versatile applications of mRNA therapeutics were related to active pharmaceutical ingredients, drug delivery systems and good manufacturing practice. Based on an analysis of therapeutic areas beyond infectious disease, in-house manufacturing facilities of biotech firms did not significantly affect clinical development progress, but they proved necessary for pipeline expansion. A series of case studies suggested a paradigm of dual-purpose manufacturing in early-phase innovation, in which biotech firms developing mRNA therapies aim both to accelerate clinical development and to establish the supply chain infrastructure for broader dissemination and growth. In this early-phase landscape, manufacturing serves as a fundamental strategic pillar in the development of mRNA therapies.