ArticleNPJ vaccines2023
Lyophilization process optimization and molecular dynamics simulation of mRNA-LNPs for SARS-CoV-2 vaccine.
Article in NPJ vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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Who cites it
43 citing papers in PubMed.
- mRNA lipid nanoparticle vaccines: current status, challenges and future prospects.Molecular biomedicine · 2026Review
- Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles.AAPS PharmSciTech · 2026Article
- Next-Generation Nanocarrier Platforms for RNA Vaccines: Advances in Formulation, Stability Engineering, and Translational Manufacturing Challenges.Pharmaceutics · 2026Review
- Review
- Nanoengineering Systems for Gene Therapy: Mechanisms, Modalities, and Future Directions.International journal of molecular sciences · 2026Review
- Osmolyte-Based Formulations for Enhanced Thermal Stability of mRNA Drug Substance: A Systematic Screening and Optimization Study.Pharmaceutical research · 2026Article
- Analytical Characterization and Stability Assessment of RNA-Based Vaccines.Pharmaceutics · 2026Review
- Therapeutic peptides and proteins: Status and developments in drug delivery.Journal of controlled release : official journal of the Controlled Release Society · 2026Review
- Stabilization strategies and advancements in lyophilization to preserve integrity and efficacy of next-generation biologicals.International journal of pharmaceutics: X · 2026Review
- Transdermal Delivery of an mRNA-Liposome Vaccine via Dissolving Microneedle to Preserve Vaccine Activity and Enhance Immune Activation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Nanoparticulate protectants for the dry storage of protein therapeutics.Nanomedicine (London, England) · 2026Review
- Article
- Freezing-Induced Stress in mRNA-Lipid Nanoparticles During Lyophilization: Mechanistic Insights From Process and Formulation Studies.Pharmaceutical research · 2026Article
- Article
- Nanomaterials in gene therapy and genome editing: challenges and emerging directions.Journal of nanobiotechnology · 2025Review
- Lipid nanoparticle-based mRNA platforms for mucosal HIV vaccines: formulation advances, immune mechanisms, and translational pathways.Archives of microbiology · 2025Review
- Post-encapsulation methods for the preparation of mRNA-LNPs.Drug delivery and translational research · 2025Article
- The impact of chemical reactivity on the quality and stability of RNA-LNP pharmaceuticals.Nature reviews. Chemistry · 2025Review
- Physiological Barriers to Nucleic Acid Therapeutics and Engineering Strategies for Lipid Nanoparticle Design, Optimization, and Clinical Translation.Pharmaceutics · 2025Review
- A Wearable Electrochemical Biosensor for Salivary Detection of Periodontal Inflammation Biomarkers: Molecularly Imprinted Polymer Sensor with Deep Learning Integration.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Some studies have shown that lyophilization significantly improves the stability of mRNA-LNPs and enables long-term storage at 2-8 °C. However, there is little research on the lyophilization process of mRNA-lipid nanoparticles (LNPs). Most previous studies have used empirical lyophilization with only a single lyoprotectant, resulting in low lyophilization efficiency, often requiring 40-100 h. In the present study, an efficient lyophilization method suitable for mRNA-LNPs was designed and optimized, shortening the total length of the lyophilization process to 8-18 h, which significantly reduced energy consumption and production costs. When the mixed lyoprotectant composed of sucrose, trehalose, and mannitol was added to mRNA-LNPs, the eutectic point and collapse temperature of the system were increased. The lyophilized product had a ginger root-shaped rigid structure with large porosity, which tolerated rapid temperature increases and efficiently removed water. In addition, the lyophilized mRNA-LNPs rapidly rehydrated and had good particle size distribution, encapsulation rate, and mRNA integrity. The lyophilized mRNA-LNPs were stable at 2-8 °C, and they did not reduce immunogenicity in vivo or in vitro. Molecular dynamics simulation was used to compare the phospholipid molecular layer with the lyoprotectant in aqueous and anhydrous environments to elucidate the mechanism of lyophilization to improve the stability of mRNA-LNPs. This efficient lyophilization platform significantly improves the accessibility of mRNA-LNPs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.