Executive Summary Pfizer has introduced a new platform called USTAT (Unified Sequential Template Amplification and Transcription). The platform uses Rolling Circle Amplification (RCA) to establish an mRNA manufacturing process that does not rely on traditional plasmid DNA. The time from DNA template generation to mRNA production can potentially be reduced to approximately two days. RNA quality approaches that of conventional plasmid DNA-based manufacturing, although challenge

Introduction Messenger RNA (mRNA), once a niche topic confined to molecular biology laboratories, has rapidly emerged as one of the most transformative technologies in modern medicine. While the COVID-19 pandemic brought mRNA vaccines into the global spotlight, their success was not an overnight miracle—it was the culmination of decades of foundational research, engineering breakthroughs, and persistent efforts to overcome the inherent fragility of RNA. Today, mRNA therapeuti