mRNA Digital Week. Analytical Methods for a Well-Characterized mRNA Drug Substance

Though much of the regulatory filing requirements for mRNA-based therapeutics can be compared with those for traditional biologics, others are not yet well defined. Like traditional biologic products and processes, mRNA-based products require controls on the quality of the starting material (including cell banking), consistency of manufacturing processes, identification of critical process parameters, clearance of impurities, establishment of environmental controls to meet safety requirements, and the thorough characterization of structure, purity, and efficacy. This has posed some challenges in analytical method development to ensure qualification for intended use. We discuss some of these challenges and solutions to support the requirements for characterization of structure, purity, and efficacy of an mRNA Drug Substance.