Quality by Design for enabling RNA platform production processes
Simon Daniel, Zoltán Kis, Cleo Kontoravdi, Nilay Shah
Abstract
RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.
Topics & Concepts
Production (economics)Biochemical engineeringQuality (philosophy)RNAComputational biologyComputer scienceChemistryBiotechnologyBiologyEngineeringBiochemistryPhysicsGeneMacroeconomicsEconomicsQuantum mechanicsCRISPR and Genetic EngineeringViral Infectious Diseases and Gene Expression in InsectsRNA and protein synthesis mechanisms