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 Following the success of COVID-19 vaccines, mRNA technology has rapidly emerged as one of the most important platforms in modern biotechnology . By enabling human cells to temporarily produce therapeutic proteins, mRNA therapeutics are being explored across a wide range of medical applications, including: Vaccines Cancer immunotherapy Protein replacement therapies Gene editing (CRISPR delivery) However, mRNA molecules are inherently fragile. Without protection,