USP publishes Draft Guideline on Analytical Methods for mRNA Vaccines

At the beginning of February, the United States Pharmacopoeia (USP) published a draft guideline on "Analytical Methods for the Quality of mRNA Vaccines". With this, the Expert Committee: Biologics Monograph 3 - Complex Biologics & Vaccines of the USP has considered the increasing importance of such products.

This guidance document is primarily intended for suppliers and manufacturers of mRNA vaccines, contract manufacturers, drug testing agencies, regulatory authorities and QA/QC specialists. Comments on this draft can be submitted to the USP until 31 May.


The background for this guide lies in the rapidly increasing worldwide need for information on quality assurance and quality control of mRNA vaccines. Research on such products, whether in the field of vaccines against viral diseases such as Zika, rabies or CVM, has been going on for years, but the use of these technologies in emerging infectious diseases, as is now the case with COVID-19, or in cancer, therapeutic protein replacement and genetic diseases is also being intensively researched. Even if the target direction is different in terms of diseases, the same or similar challenges or requirements often arise in the development of processes and in the area of quality assurance and control.

Involvement of stakeholders

A lot of useful information can already be derived from the findings of the previous work, i.e. the variety of research and preclinical data and the clinical trials conducted so far, which could also be used in the production of the COVID-19 vaccines. This and the data from the pandemic period provide an initial basis for appropriate guidelines. The USP writes: "The USP and global stakeholders have identified a need for analytical methods and best practices to support the assessment of the overall quality characteristics of mRNA vaccines. A standard set of analytical methods would assist vaccine developers, manufacturers, regulatory agencies, and national control laboratories worldwide by providing methods to help accelerate the development and release of safe and effective vaccines and protect against substandard and counterfeit vaccine products."

Accordingly, the USP has included some methods in the draft (see table).

As a basis, the USP/Expert Committee has prepared this first draft, which is now available for public, or appropriate stakeholder, comment and provides the opportunity to submit alternative methods and additional documentation, including validation documents, to the methods presented in the draft guideline.

More detailed information on the draft guidance and the comments on it can be found on the USP website.

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