USP Developing mRNA Quality Guidelines to Help Bring Innovative Medicines to Market Faster

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USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

The US Pharmacopeia (USP), a global independent scientific organization, has identified the need for guidelines and analytical procedures regarding quality assessments for messenger (mRNA) vaccines and technology. USP is seeking scientific input on new draft guidelines, Analytical Procedures for mRNA Vaccine Quality.

mRNA-based therapies and other innovative technologies must be of good quality, safe, and effective in order to gain trust and confidence to the public. The success in the application of mRNA technology is still relatively new, and guidelines and industry standards are still evolving. Developing common standards for the assessment of mRNA quality would allow developers, manufacturers, regulatory agencies, and national control laboratories worldwide to be able to 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, PhD, USP’s executive vice president and chief science officer, in the press release. “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.”


Source: USP