Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine.
Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine.
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冷冻干燥为脂质纳米颗粒配方、核苷修饰的信使核糖核酸疫苗提供了长期稳定性。
DOI：
10.1016/j.ymthe.2022.02.001
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发表时间：
2022-05-04
期刊：
影响因子：
--
通讯作者：
Pardi N
中科院分区：
文献类型：
--
作者：
Muramatsu H;Lam K;Bajusz C;Laczkó D;Karikó K;Schreiner P;Martin A;Lutwyche P;Heyes J;Pardi N
Lipid nanoparticle (LNP)-formulated nucleoside-modified mRNA vaccines have proven to be very successful in the fight against the coronavirus disease 2019 (COVID-19) pandemic. They are effective, safe, and can be produced in large quantities. However, the long-term storage of mRNA-LNP vaccines without freezing is still a challenge. Here, we demonstrate that nucleoside-modified mRNA-LNPs can be lyophilized, and the physicochemical properties of the lyophilized material do not significantly change for 12 weeks after storage at room temperature and for at least 24 weeks after storage at 4°C. Importantly, we show in comparative mouse studies that lyophilized firefly luciferase-encoding mRNA-LNPs maintain their high expression, and no decrease in the immunogenicity of a lyophilized influenza virus hemagglutinin-encoding mRNA-LNP vaccine was observed after 12 weeks of storage at room temperature or for at least 24 weeks after storage at 4°C. Our studies offer a potential solution to overcome the long-term storage-related limitations of nucleoside-modified mRNA-LNP vaccines. Long-term storage of mRNA-LNP vaccines requires freezing, posing a limitation for this successful, novel vaccine class. Pardi and colleagues demonstrate that lyophilization provides substantial physicochemical stability for mRNA-LNPs. Importantly, the authors observe no decrease in the immunogenicity of a lyophilized influenza mRNA-LNP vaccine after storage at 4°C for 24 weeks.
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DOI：
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发表时间：
2013-10-01
影响因子：
4.9
作者：
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通讯作者：
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DOI：
10.1056/nejmoa2034577
发表时间：
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期刊：
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影响因子：
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作者：
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DOI：
10.1038/s41578-021-00358-0
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7.8
作者：
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通讯作者：
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DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
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COVE Study Group