Evidence map›Paper›PMID 42627629›Full record

ArticlePharmaceutical research2026

Comprehensive Analytical Characterization of mRNA Influenza Vaccine Under Stress Conditions: Implications for Stability and Quality Control.

Jiyoun Kim, Jiyoung Sim, Seulgi Park, Jiyoung Ma, Jihoon Kim, Yunji Kum, Hyewon Lee, Inyoung Huh, Jaeseung Lee, Yeon-Jung Kim and 3 more

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In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Jiyoun KimR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea. jykim77@gccorp.com.ORCID http://orcid.org/0009-0006-0906-0415
Jiyoung SimR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Seulgi ParkR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Jiyoung MaR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Jihoon KimR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Yunji KumR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Hyewon LeeR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Inyoung HuhR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Jaeseung LeeR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Yeon-Jung KimR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Byoungju LeeR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Jeungwoon HongR&D Quality Management Unit, GC Biopharma, Yongin, 16924, Gyeonggi, Republic of Korea.
Min-Duk SeoDepartment of Molecular Science and Technology, Ajou University, Suwon, Gyeonggi, 16499, Republic of Korea. mdseo@ajou.ac.kr.

Funding

Gyeonggi-do Regional Research Center GRRCAjou2023-B03
6 · The paper itself

Abstract

purposeThis study aimed to characterize the physicochemical stability of mRNA-lipid nanoparticle (LNP) influenza vaccine candidates under various environmental stressors using forced degradation studies (FDSs) and to correlate these changes with in vitro protein expression.

methodsFDSs were conducted to evaluate the effects of temperature, oxidation, hydrolysis, and agitation on mRNA-LNP formulations. Comprehensive analytical techniques were employed to monitor the purity and integrity of mRNA, mRNA encapsulation efficiency, in vitro expression, LNP components, and particle characteristics.

resultsThe study revealed hydrolysis-induced degradation of distearoylphosphatidylcholine (DSPC), a key LNP component, and rapid oxidation-induced mRNA degradation within the LNPs. Agitation was found to increase LNP size, decrease mRNA encapsulation efficiency, and subsequently reduce in vitro protein expression.

conclusionsWe established robust analytical methods to monitor the quality and stability of mRNA-LNP products. These findings provide a critical foundation for integrated analytical strategies to enhance the stability of mRNA-LNP therapeutics and vaccines during storage, transport, and clinical application.

Indexed as

Influenza VaccinesNanoparticlesRNA, MessengerDrug StabilityHumansHydrolysisOxidation-ReductionParticle SizePhosphatidylcholinesQuality ControlTemperatureInfluenza VaccinesPhosphatidylcholinesRNA, MessengerAnalytical characterizationDSPCForced degradation studymRNA-LNPPhysicochemical stability

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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.