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.
“We all witnessed the first successful use of mRNA technology in the global fight against COVID-19, and we are very optimistic about the promise of mRNA technology applied to therapies and vaccines for a variety of conditions. The quality of mRNA products must be a top priority in order to facilitate market entry and build patient and provider trust.” said Jaap Venema, Ph.D., USP’s Executive Vice President & Chief Science Officer. “USP convenes industry and scientific experts in emerging technology areas to identify best practices for understanding quality as that technology continues to grow. Without that common understanding, manufacturers must develop their own in-house methods, taking attention and resources away from the successful application of that technology.”
Since the start of the pandemic, USP resources have helped to assure stakeholders that mRNA vaccines—and other vaccine platforms—are manufactured, distributed and administered efficiently and effectively, providing tools to manage quality all along the supply chain from manufacturing best practices to supporting the frontline health workers administering them. The following resources are currently available:
- COVID-19 Vaccine Handling Toolkit
- COVID-19 Vaccine Handling International Guide
- Maximizing Doses for Pfizer and Moderna Fact Sheets
- COVID-19 Vaccines Beyond Use Dates Fact Sheet
- COVID-19 Vaccine Transportation Guide
- Vaccine Quality Attributes Toolkits
To advance the draft guidelines, USP is calling on industry, academic and government experts with experience or interest in mRNA vaccines and technology to provide feedback on the methods and recommend additional information to support the understanding of mRNA quality. Initial feedback to this draft will be presented by USP at the World Vaccine Congress in March. For more information, visit usp.org/mrna-quality.
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide.