Research Advances on the Stability of mRNA Vaccines

被引：75

作者：

Cheng, Feiran ^{[1
,2
]}

Wang, Yiping ^{[3
]}

Bai, Yu ^{[1
,2
]}

Liang, Zhenglun ^{[1
,2
]}

Mao, Qunying ^{[1
,2
]}

Liu, Dong ^{[1
,2
]}

Wu, Xing ^{[1
,2
]}

Xu, Miao ^{[1
,2
]}

机构：

[1] Natl Inst Food & Drug Control, Inst Biol Prod, Natl Med Prod Adm Key Lab Qual Res & Evaluat Biol, Beijing 102600, Peoples R China

[2] Natl Inst Food & Drug Control, Natl Hlth Commiss Key Lab Res Qual & Standardizat, Beijing 102600, Peoples R China

[3] Natl Inst Food & Drug Control, Ctr Reference Mat & Standardizat, Beijing 102600, Peoples R China

来源：

VIRUSES-BASEL | 2023年 / 15卷 / 03期

关键词：

mRNA; vaccines; stability; lipid nanoparticle; degradation; LONG-TERM STORAGE; LIPID NANOPARTICLES; NUCLEOSIDE MODIFICATIONS; PHOSPHODIESTER BONDS; CODON; CELL; PSEUDOURIDINE; OPTIMIZATION; LIPOSOME; CAPACITY;

D O I：

10.3390/v15030668

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

Compared to other vaccines, the inherent properties of messenger RNA (mRNA) vaccines and their interaction with lipid nanoparticles make them considerably unstable throughout their life cycles, impacting their effectiveness and global accessibility. It is imperative to improve mRNA vaccine stability and investigate the factors influencing stability. Since mRNA structure, excipients, lipid nanoparticle (LNP) delivery systems, and manufacturing processes are the primary factors affecting mRNA vaccine stability, optimizing mRNA structure and screening excipients can effectively improve mRNA vaccine stability. Moreover, improving manufacturing processes could also prepare thermally stable mRNA vaccines with safety and efficacy. Here, we review the regulatory guidance associated with mRNA vaccine stability, summarize key factors affecting mRNA vaccine stability, and propose a possible research path to improve mRNA vaccine stability.

引用

页数：16

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