Details

Autor(en) / Beteiligte

• Muramatsu, Hiromi
• Lam, Kieu
• Bajusz, Csaba
• Laczkó, Dorottya
• Karikó, Katalin
• Schreiner, Petra
• Martin, Alan
• Lutwyche, Peter
• Heyes, James
• Pardi, Norbert

Titel

Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine

Ist Teil von

• Molecular therapy, 2022-05, Vol.30 (5), p.1941-1951

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2022

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. [Display omitted] 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.