Type of Posting: General Announcement
Posting Date: 10–Feb–2022
Input Deadline: 30–Jun–2022
Expert Committee: Biologics Monograph 3 – Complex Biologics & Vaccines
Proposed Title: Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)
Suggested audience: Suppliers and manufacturers of mRNA vaccine drug substances, contract manufacturing organizations, drug testing organizations, regulatory agencies, and QA/QC specialists.
Background and objective: For decades, messenger ribonucleic acid (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 COVID-19 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-CoV-2 in the U.S.
The mRNA technology is also being investigated for developing treatments and vaccines for other emerging infectious diseases, cancer, therapeutic protein replacement, and genetic diseases. Although the mRNA technology can target diverse conditions, most applications use similar development and manufacturing processes, applying similar analytical procedures for quality assurance and control.
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.
Proposal and stakeholder engagement: 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.
USP and our BIO3 Expert Committee are releasing an early draft of the guidelines for public comments. By pursuing the early release, USP wants to solicit feedback from stakeholders on the methods described in the referenced document and encourage the submission of any alternative methods and any additional supporting documentation, including validation documents, related to the methods presented in the draft guidelines.
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).
For more information and to download the draft guidelines please click here.
Deadline for Submitting Comments
USP welcomes your feedback and encourages you to submit your supporting data within 90 days from the post of this announcement by email as described below.
Submitting your comments
Please submit your comments and supporting documents to USPVaccines@USP.org.
USP looks forward to continued engagement from industry, regulators, and other stakeholders.
This Notice was updated to extend the comment period to June 30, 2022