Evidence map›Paper›PMID 41372253›Full record

ArticleScientific reports2025

Comparative study of analytical methods for assessing mRNA integrity and identification of functional mRNA oligomers.

Perrine Lardellier, Camille Malburet, Marco Morani, Thibaut Willemin, Javier Rol-Moreno, Anouck Noir, Stéphanie Fertier-Prizzon, Marc Francois-Heude

Abstract readComparative Study
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Review
  2. Review
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

8 authors.

Perrine Lardellier, Marcy-l'Etoile, Sanofi, France.
Camille Malburet, Marcy-l'Etoile, Sanofi, France. camille.malburet@sanofi.com.
Marco Morani, Marcy-l'Etoile, Sanofi, France.
Thibaut Willemin, Marcy-l'Etoile, Sanofi, France.
Javier Rol-Moreno, Marcy-l'Etoile, Sanofi, France.
Anouck Noir, Marcy-l'Etoile, Sanofi, France.
Stéphanie Fertier-Prizzon, Marcy-l'Etoile, Sanofi, France.
Marc Francois-Heude, Marcy-l'Etoile, Sanofi, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Development of mRNA technologies has opened new horizons for both preventive vaccines and therapeutics. The rapid growth of mRNA products goes hand in hand with the need for novel analytical methods to characterize these products. One common critical quality attribute of mRNA Drug Substance (DS) and Drug Product (DP) is mRNA integrity. mRNA molecules are susceptible to degradation, often necessitating ultra-low-temperature storage of mRNA vaccines. Once degraded, mRNA can no longer be correctly translated into the target protein, leading to reduced vaccine efficacy. Therefore, robust analytical methods are crucial for understanding mRNA degradation mechanisms, optimizing formulation stability, and maximizing efficacy. In this study, we compared three analytical methods to assess mRNA integrity and purity: capillary gel electrophoresis (CGE) with fluorescent detection using a fragment analyzer (FA) device, CGE with ultraviolet (UV) detection, and ion-pairing reversed-phase chromatography (IP-RPLC) with UV detection. All three methods successfully monitored the integrity of mRNA DS and DP. IP-RPLC provided better resolution and facilitated the detection of mRNA-lipid adducts, while the FA, being more automated, enabled rapid analysis of a large number of samples. CGE-UV revealed the presence of mRNA oligomers. Further analysis showed that these oligomers could express the target protein similarly to the mRNA monomer.

Indexed as

RNA, MessengerChromatography, Reverse-PhaseElectrophoresis, CapillaryRNA StabilityRNA, MessengerAnalytical methodsCapillary gel electrophoresisCritical quality attributeHigh-performance liquid chromatographyMRNA integrityMRNA vaccinesOligomerisation

Identifiers

PMID41372253
PMCPMC12696080

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.