Learn more about USP's COVID vaccine efforts:
USP.org/COVID-19/Vaccines
To build public trust and confidence in innovative products like mRNA vaccines and therapies, they must be of good quality, safe and effective. To address the need for a common set of methods for determining mRNA quality—including verifying the identity of the drug substance, controlling impurities and measuring content for dosing—USP is developing a set of analytical methods to support developers, manufacturers, regulatory agencies and national control laboratories worldwide.
USP welcomes public comments on Analytical Procedures for mRNA Vaccines Quality - 3rd Edition.
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Read and review the draft guidelines
Submit your comments to USPVaccines@usp.org
USP mRNA Draft Guidelines
Analytical Procedures for mRNA Vaccine Quality - 3rd Edition
To advance these draft guidelines, we call on industry, academic and government experts with experience or interest in mRNA vaccines and technology to provide feedback on the methods detailed in these draft guidelines and recommend additional information to support the understanding of mRNA quality. Submission of any alternative analytical methods as well as supporting documents (e.g., validation documentation) is encouraged.
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