Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials
Jill Whitley, Christopher Zwolinski, Christian Denis, Maureen Maughan, Leonie Hayles, David Clarke, Meghan Snare, Liao Hong, Sean Chiou, Tina Marmura, Holly Zoeller, Ben Hudson, John Peart, Monica M. Johnson, Amelia Karlsson, Yunfei Wang, Cynthia A. Nagle, Cherell Harris, Daniel Tonkin, Stephanie Fraser, Lieza Capiz, Christina L. Zeno, Yvonne Meli, Diana Martik, Daniel A. Ozaki, Amy Caparoni, Jason E. Dickens, Drew Weissman, Kevin O. Saunders, Barton F. Haynes, Gregory D. Sempowski, Thomas N. Denny, Matthew R. Johnson
Topics & Concepts
ScalabilityGood manufacturing practiceManufacturing processProcess developmentCold chainQuality (philosophy)Messenger RNAScale (ratio)Process (computing)Production (economics)Biochemical engineeringComputer scienceRisk analysis (engineering)BiotechnologyComputational biologyManufacturing engineeringEngineeringMedicineBiologyRegulatory affairsMaterials scienceQuantum mechanicsEconomicsOperating systemPhilosophyMechanical engineeringMacroeconomicsBiochemistryComposite materialEpistemologyGenePhysicsDatabaseRNA Interference and Gene DeliveryVirus-based gene therapy researchViral Infections and Immunology Research