Rompicherla Srividya, Navapet Vikas Reddy, Tirumala Shreya, Komere Vasu, Appala Naidu Uttaravalli, Manjakuppam Malika, A. V. Raghavendra Rao
Exploration of RNA-based biologics focusing on upstream and downstream activities including capping methods, purification, and lipid nanoparticle encapsulation using automated, modular, and scalable platforms compliant with Good Manufacturing Practice (GMP). Key results include the examination of technological inventions like microfluidics, single use bioreactors, and real time analytical tools revolutionizing RNA biomanufacturing, along with regulatory considerations, cost-effectiveness, and cold-chain logistics. Main conclusion is the importance of biomanufacturing in the swift development, scale-up, and delivery of RNA therapeutics, and strategic research and development directions such as thermostable formulation, decentralized manufacture centers, and personalized RNA pharmaceuticals.
Among contemporary treatment methods, RNA-based therapy, especially messenger RNA (mRNA) vaccines, has become a game changer in the world of modern medicine, especially after the COVID-19 pandemic outbreak. The chapter explores the changing landscape of RNA-based biologics, the centrality of biomanufacturing therein in the swift development, scale-up and delivery to the world. We consider upstream and downstream activities that distinguish RNA therapeutics from in-vitro transcription (IVT), capping methods, purification, and lipid nanoparticle (LNP) encapsulation. The focus revolves around the merger of automated, modular and scalable platforms well conforming to the rigorous prescriptions of Good Manufacturing Practice (GMP). Besides, the chapter also presents technological inventions like microfluidics, single use bioreactors and real time analytical tools which are revolutionizing RNA biomanufacturing. Regulatory considerations, cost-effectiveness, and cold-chain logistics are also examined. This paper aims to explain the accomplishments and least productive processes of modern systems based on the case studies of contemporary campaigns in mRNA vaccine production. The last part of the chapter summarizes some strategic research and development directions such as thermostable formulation, decentralized manufacture centers, and path to personalized RNA pharmaceuticals.