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mRNA Quality Assessment and USP Guidelines

Following the rapid and successful deployment of mRNA vaccines during the COVID-19 pandemic, over 150 mRNA vaccines are in development, with further therapeutic applications in oncology, cardiovascular and genetic diseases and forecasts predict a high level of growth in products using this drug manufacturing platform. USP engaged with stakeholders in government, drug development, pharmaceutical companies and other experts to build consensus on relevant quality attributes for mRNA-based products and appropriate analytical methods. As part of this effort, USP worked with vaccine experts to generate draft guidelines (Analytical Procedures for mRNA Vaccine Quality) and solicited feedback from stakeholders to update and evolve the guidelines. This presentation will provide an overview of USP updated guidelines and plans for further assessment and qualification of analytical methods presented therein. Physical, chemical, and structural elements of drug substance and drug product and how they relate to product quality attributes will also be discussed.