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

IF 4.1 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2026-09-01 Epub Date: 2026-08-21 DOI:10.1007/s11095-026-04175-4

Jiyoun Kim, Jiyoung Sim, Seulgi Park, Jiyoung Ma, Jihoon Kim, Yunji Kum, Hyewon Lee, Inyoung Huh, Jaeseung Lee, Yeon-Jung Kim, Byoungju Lee, Jeungwoon Hong, Min-Duk Seo

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引用次数: 0

Abstract

Purpose: This 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.

Methods: FDSs 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.

Results: The 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.

Conclusions: We 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.

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应激条件下流感疫苗mRNA的综合分析表征：对稳定性和质量控制的影响。

目的：本研究旨在通过强制降解研究（FDSs）来表征mrna -脂质纳米颗粒（LNP）流感疫苗候选物在不同环境胁迫下的理化稳定性，并将这些变化与体外蛋白表达联系起来。方法：采用FDSs评价温度、氧化、水解和搅拌对mRNA-LNP配方的影响。采用综合分析技术监测mRNA的纯度和完整性、mRNA包封效率、体外表达、LNP成分和颗粒特性。结果：该研究揭示了水解诱导的LNP关键成分二硬脂酰磷脂酰胆碱（dsc）降解和LNP内快速氧化诱导的mRNA降解。搅拌可增加LNP的大小，降低mRNA的包封效率，从而降低体外蛋白表达。结论：我们建立了可靠的分析方法来监测mRNA-LNP产品的质量和稳定性。这些发现为提高mRNA-LNP疗法和疫苗在储存、运输和临床应用过程中的稳定性提供了综合分析策略的关键基础。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.