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Maintaining Quality for mRNA Vaccines
The COVID-19 pandemic catapulted mRNA technology to the forefront of public consciousness in 2021 when Emergency Authorization status was granted to two mRNA vaccines. mRNA therapies are a newer application of technology engineered to mimic processed, mature nucleic acid transcripts present in eukaryotic cytoplasms. As a class of drug product that has only recently received its first FDA approval, developing strong quality controls to ensure the purity and efficacy of the drug substance is critical for guarding the safety of patients.
Generally, vaccine regulations are well-established worldwide and supplemented by national and international guidelines. In the United States, the Public Health Service Act (42 USC) and Code of Federal Regulations (21 CFR) provide a framework for vaccine development, and the European Medicines Agency (EMA) has corollary guidelines for drugs intended to be marketed in the European Union. More recently, the US Pharmacopeia (USP) published draft guidelines for analytical procedures for mRNA vaccine quality to bolster international harmonization. Despite these guidelines and regulations, best practices for assuring mRNA vaccine quality are continuously improving to keep pace with industry needs. Executive Summary available now.
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