Evidence map›Paper›PMID 39408932›Full record

ArticleInternational journal of molecular sciences2024

Comprehensive Optimization of a Freeze-Drying Process Achieving Enhanced Long-Term Stability and In Vivo Performance of Lyophilized mRNA-LNPs.

Teresa Alejo, Alfonso Toro-Córdova, Laura Fernández, Andrea Rivero, Andrei Mihai Stoian, Luna Pérez, Victor Navarro, Juan Martínez-Oliván, Diego de Miguel

Abstract read
In one paragraph

Article in International journal of molecular sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Teresa AlejoCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.ORCID 0000-0002-9324-0446
Alfonso Toro-CórdovaCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.ORCID 0000-0002-0087-7780
Laura FernándezCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Andrea RiveroCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Andrei Mihai StoianCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Luna PérezCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Victor NavarroCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Juan Martínez-OlivánCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.
Diego de MiguelCerTest Biotec S.L., 50840 San Mateo de Gállego, Spain.ORCID 0000-0002-8486-8514

Funding

Gobierno de Aragón IDMF/2021/0009Ministerio de Ciencia, Innovación y Universidades PTQ2021-011651Ministerio de Ciencia, Innovación y Universidades PTQ2022-012362
6 · The paper itself

Abstract

The success of mRNA vaccines against SARS-CoV-2 has prompted interest in mRNA-based pharmaceuticals due to their rapid production, adaptability, and safety. Despite these advantages, the inherent instability of mRNA and its rapid degradation in vivo underscores the need for an encapsulation system for the administration and delivery of RNA-based therapeutics. Lipid nanoparticles (LNPs) have proven the most robust and safest option for in vivo applications. However, the mid- to long-term storage of mRNA-LNPs still requires sub-zero temperatures along the entire chain of supply, highlighting the need to develop alternatives to improve mRNA vaccine stability under non-freezing conditions to facilitate logistics and distribution. Lyophilization presents itself as an effective alternative to prolong the shelf life of mRNA vaccines under refrigeration conditions, although a complex optimization of the process parameters is needed to maintain the integrity of the mRNA-LNPs. Recent studies have demonstrated the feasibility of freeze-drying LNPs, showing that lyophilized mRNA-LNPs retain activity and stability. However, long-term functional data remain limited. Herein, we focus on obtaining an optimized lyophilizable mRNA-LNP formulation through the careful selection of an optimal buffer and cryoprotectant and by tuning freeze-drying parameters. The results demonstrate that our optimized lyophilization process maintains LNP characteristics and functionality for over a year at refrigerated temperatures, offering a viable solution to the logistical hurdles of mRNA vaccine distribution.

Indexed as

COVID-19Freeze DryingNanoparticlesRNA, MessengerSARS-CoV-2AnimalsCOVID-19 VaccinesCryoprotective AgentsHumansLipidsLiposomesMicemRNA VaccinesRNA StabilityCOVID-19 VaccinesCryoprotective AgentsLipid NanoparticlesLipidsLiposomesmRNA VaccinesRNA, Messengerfreeze-drying/lyophilizationmRNA-LNPsthermostable vaccines

Identifiers

PMID39408932
PMCPMC11476828

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.