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: The Next Bottleneck in mRNA Therapeutics May Not Be RNA—It May Be the LNP Since the successful launch of COVID-19 mRNA vaccines, mRNA technology has rapidly expanded beyond infectious diseases into areas such as cancer immunotherapy, gene editing, protein replacement therapy, and regenerative medicine. Many scientists believe the next decade will be the golden age of RNA therapeutics. However, anyone who has worked in mRNA drug development quickly realizes a fun

Introduction: Why Cancer Vaccines Are Back in Focus For decades, the concept of a cancer vaccine occupied an uncertain space in oncology. Early therapeutic cancer vaccine efforts frequently failed to demonstrate meaningful clinical benefit, leading to skepticism about whether the immune system could be reliably trained to recognize and eliminate tumors (1). This perception has shifted dramatically in recent years. Advances in tumor genomics, neoantigen discovery, and RNA del