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

mRNA-based modalities for infectious disease management

“…The lyophilized vaccine also induced strong immune response and generated high level neutralizing antibody titer. A cross-protection capability was also observed by mRNA-Delta and mRNA-Omicron vaccine against other variants [147].…”

“…Moreover, the lyophilized form of mRNA-LNP achieved long-term storage in the range of 2-8 °C. The significant improved thermostability was further confirmed with various LNPs encapsulating different mRNA molecules, which determined their widespread applicability [147].…”

mRNA vaccines and clinical research in Africa - From hope to reality

“…Moreover, the lyophilized mRNA vaccine successfully protected mice from infection with Delta challenge. Muramatsu and colleagues [ 10 ] offered additional evidence on the applicability of the lyophilized mRNA vaccine with less need for cooling. They prepared a lyophilized influenza virus hemagglutinin-encoding mRNA-LNP vaccine and stored it at room temperature or 4 °C for three months and six months, respectively.…”

Overcoming the challenge of long-term storage of mRNA-lipid nanoparticle vaccines

“…In this issue of Molecular Therapy, Muramatsu, et al demonstrate that mRNA-LNPs can be lyophilized (freeze-dried) and stored at ambient temperature for 12 weeks and at 4 C for at least 24 weeks without substantial changes to their physical properties or mRNA delivery efficiency. 5 Their findings on the long-term storage and stability of lyophilized mRNA-LNPs are critical to the widespread development and implementation of LNPs for COVID-19 and other diseases.…”

“…In this article, Muramatsu, et al thoroughly examine the stability and mRNA delivery efficiency of lyophilized LNPs stored under various storage conditions (À80 C, À20 C, 4 C, 25 C, or 42 C) at multiple timepoints over the course of 24 weeks. 5 Results from each storage condition were compared to LNPs stored in their frozen liquid form (not lyophilized) at À80 C to assess the impact of lyophilization, temperature, and storage time on LNP performance. They studied two nucleoside-modified mRNA cargos, luciferase mRNA or influenza virus hemagglutinin (PR8 HA) mRNA, to evaluate delivery by imaging or immunogenicity, respectively.…”