9th June 2022
Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)
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.