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Lipid self-assembling nanoparticles as a novel platform for mRNA-based vaccination.
Arianna De Chiara1,2, Valeria Nele3, Alessia Angelillo3
1CEINGE-Biotecnologie Avanzate S.c.a.r.l., Via Gaetano Salvatore 486, 80131 Naples, Italy.
Molecular Therapy. Nucleic Acids
|February 25, 2026
Summary
New self-assembling nanoparticle (SANP) technology enables messenger RNA (mRNA) vaccines to be stored at 4°C. This breakthrough enhances mRNA vaccine stability and distribution, overcoming limitations of current lipid nanoparticle formulations.
Area of Science:
- Biotechnology
- Nanomedicine
- Vaccinology
Background:
- Synthetic messenger RNA (mRNA) formulated in lipid nanoparticles (mRNA-LNPs) shows promise for gene therapy and vaccines.
- Current mRNA-LNP formulations require cold-chain storage, posing challenges for transport and distribution.
Purpose of the Study:
- To develop a novel nanoparticle technology for stabilizing mRNA-based therapeutics.
- To overcome the cold-storage limitations of existing mRNA vaccine formulations.
Main Methods:
- Introduction of a lipid self-assembling nanoparticle (SANP) technology for mRNA formulation.
- Preparation of mRNA-loaded SANPs (mRNA-SANPs) by simple mixing immediately before use.
- Characterization of mRNA-SANPs for size, encapsulation efficiency, colloidal stability, and hemolytic activity.
- Evaluation of mRNA-SANP efficacy and safety in mice via intramuscular (IM) and intravenous (IV) administration.
- Analysis of nanoparticle-protein interactions and correlation with in vivo biodistribution.
- Assessment of immune response to SARS-CoV-2 spike protein-encoding mRNA-SANPs.
Main Results:
- mRNA-SANPs demonstrated sub-200 nm size, high mRNA encapsulation, and excellent colloidal stability.
- Formulations were stable at 4°C without freezing, enhancing vaccine stability.
- In vivo studies showed high transgene expression with no observed toxicity or pro-inflammatory cytokine release.
- Protein fingerprint analysis revealed specific nanoparticle-protein interactions linked to biodistribution.
- Administration of mRNA-SANPs encoding the SARS-CoV-2 spike protein elicited a significant immune response.
Conclusions:
- SANP technology offers a stable, easy-to-prepare alternative to traditional mRNA-LNP formulations.
- mRNA-SANPs can be stored and transported at 4°C, improving accessibility of mRNA therapeutics.
- The developed mRNA-SANPs are safe and effective in vivo, demonstrating potential for next-generation vaccines and gene therapies.
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