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Research progress on the quality control of mRNA vaccines
- Source :
- Expert Review of Vaccines, Vol 23, Iss 1, Pp 570-583 (2024)
- Publication Year :
- 2024
- Publisher :
- Taylor & Francis Group, 2024.
-
Abstract
- ABSTRACTIntroduction The mRNA vaccine technologies have progressed rapidly in recent years. The COVID-19 pandemic has accelerated the application of mRNA vaccines, with research and development and clinical trials underway for many vaccines. Application of the quality by design (QbD) framework to mRNA vaccine development and establishing standardized quality control protocols for mRNA vaccines are essential for the continued development of high-quality mRNA vaccines.Areas covered mRNA vaccines include linear mRNA, self-amplifying mRNA, and circular RNA vaccines. This article summarizes the progress of research on quality control of these three types of vaccines and presents associated challenges and considerations.Expert opinion Although there has been rapid progress in research on linear mRNA vaccines, their degradation patterns remain unclear. In addition, standardized assays for key impurities, such as residual dsRNA and T7 RNA polymerase, are still lacking. For self-amplifying mRNA vaccines, a key focus should be control of stability in vivo and in vitro. For circular RNA vaccines, standardized assays, and reference standards for determining degree of circularization should be established and optimized.
- Subjects :
- mRNA vaccine
quality control
research progress
Internal medicine
RC31-1245
Subjects
Details
- Language :
- English
- ISSN :
- 14760584 and 17448395
- Volume :
- 23
- Issue :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- Expert Review of Vaccines
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.2cc9689dc4994bc2b05180a0a568fed5
- Document Type :
- article
- Full Text :
- https://doi.org/10.1080/14760584.2024.2354251