USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.
To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.