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一种无标签的多参数选方法,用于预测mRNA-LNP配方的稳定性

Yimei Sun¹, Cheng-Han Ye², Han Gao³

¹Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.

International journal of pharmaceutics

|January 12, 2026

概括

一种新的热分析方法快速评估信使RNA (mRNA) 脂质纳米粒子 (LNP) 的稳定性. 这种技术可以更快地实时评估体稳定性,以改善疫苗和基因疗法配方的开发.

科学领域:

生物技术是生物技术.
制药科学制药科学
材料科学材料科学材料科学

背景情况:

传递 RNA (mRNA) 技术正在快速发展,脂质纳米粒子 (LNP) 对于疫苗和基因治疗的交付变得至关重要.
mRNA-LNP配方的体稳定性直接影响其治疗效果.
目前用于预测配方稳定的方法通常是缓慢和复杂的.

研究的目的:

开发一种快速,无标签,实时的方法来评估mRNA-LNP的体稳定性.
为高效的配方选引入新的热稳定性读数.
将开发的方法与传统的加速稳定性研究进行比较.

主要方法:

建立了一个多参数热分析试验,实时监测度,累积半径 (r h) 和散射.
评估了六种mRNA-LNP配方,缓冲剂,防腐剂和pH的变化.
引入聚合开始温度 (Tagg) 和r h的变化 (Δr h) 作为关键稳定性指标.

主要成果:

热分析方法成功捕获了mRNA-LNP热诱导的体稳定性变化.
一个重新定义的聚合开始温度 (Tagg) 和 Δr h 有效地确定了早期的结构扰动.
使用Tagg和Δrh的物流回归建模与40°C加速稳定性数据有很好的一致性.

结论:

开发的热分析策略为mRNA-LNP配方的早期查提供了快速有效的工具.
与传统的稳定性研究相比,这种方法显著减少了评估时间.
需要进一步验证,以确认在各种mRNA载荷和脂质组合中适用性.

关键词:

聚合开始的温度 (T(agg))配方选配方选配方选配方选没有标签的稳定性分析.热剖面化是热剖面化的一个方法.在 mRNA-LNP 之间.

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