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Analytical Procedures for mRNA Vaccine Quality | USP Draft Guidelines

Suggested audience: Suppliers and manufacturers of mRNA vaccine drug substances, contract manufacturing organizations, drug testing organizations, regulatory agencies, and QA-QC specialists.

For decades, mRNA technology have been investigated as a platform for vaccines for flu, Zika, rabies, and cytomegalovirus (CMV), generating substantial amounts of research and preclinical data demonstrating safety, efficacy, and versatility leading to multiple human clinical trials.

When the COVID19 pandemic emerged, vaccine manufacturers leveraged research outcomes combined with their R&D and manufacturing expertise to rapidly develop vaccines using mRNA technology. 

As a result, the mRNA platform became the first modality to receive emergency use authorization and then approval for SARS-CoV2 in the U.S. 

The mRNA technology is also being investigated for developing treatments and vaccines for other emerging infectiousdiseases, cancer, therapeutic protein replacement, and genetic diseases. 

In order to aid the global need for quality assurance of mRNA vaccines, USP intends to develop a new general chapter with methods to support the testing of quality attributes for mRNA-based vaccines. 

USP and global stakeholders have identified a need for analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccines.

A standard set of analytical methods would support 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 guard against substandard and falsified vaccine products. 

As a first step towards developing a procedural chapter on the testing of mRNA vaccines, USP’s BIO3 Expert Committee has developed draft guidelines containing methods to support testing of mRNA quality attributes.

Methods described in the draft guidelines have been adapted from publicly available sources and have not yet been verified or validated by USP. 

Preliminary outline of the proposed guidelines: 

The following table outlines the proposed methods for assessing quality attributes for mRNA bulk drug substances. 

The draft guidelines include methods to evaluate the content, identity, purity, mRNA integrity, and safety parameters. 

Some of these methods may also apply to the vaccine products but may require additional sample handling procedures (e.g., mRNA extraction).

Resource Person: Barbara Pirola

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