USP calls for industry input in developing mRNA quality guidelines

The US Pharmacopeia (USP) is asking industry, academic and government experts with experience or interest in messenger RNA (mRNA) vaccines and technology to provide feedback on new draft guidelines: Analytical Procedures for mRNA Vaccine Quality.

The 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.

According to USP, since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. Therefore, a common approach for assessing mRNA quality is needed to 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,” explained Dr Jaap Venema, 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 seeking scientific input 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.