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验证一种 HPLC-CAD 方法,用于测量新型 LNp 包裹的 COVID-19 mRNA 疫苗的脂质含量。

Validation of an HPLC-CAD method for measuring the lipid content of novel LNP-encapsulated COVID-19 mRNA vaccines.

机构信息

Yunnan Institute of Supervision and Inspection for Food and Drug, Kunming, Yunnan 650500, PR China; Public Service Platform for Industrial Technology Foundation of the Ministry of Industry and Information Technology, Kunming, Yunnan 650500, PR China.

Yunnan Key Laboratory of Stomatology, Kunming Medical University, Kunming, Yunnan 650500, PR China; Department of Dental Research, The Affiliated Stomatology Hospital of Kunming Medical University, Kunming, Yunnan 650500, PR China.

出版信息

J Virol Methods. 2024 Dec;330:115040. doi: 10.1016/j.jviromet.2024.115040. Epub 2024 Oct 9.

Abstract

Lipid nanoparticles (LNPs) are frequently employed as mRNA vaccine delivery vehicles. LNPs are made up of four types of lipids: cationic lipid, PEG-lipid conjugate, zwitterionic helper phospholipid, and cholesterol. LNP distribution efficiency is significantly impacted by lipid composition, which also controls LNP stability and bilayer fluidity. The various lipids used in the formulation system have distinct properties and contents. To aid in the development of new drugs and vaccines, we developed and validated an HPLC-CAD method for identifying and determining the amounts of four lipids in Yuxi Watson Biotechnology Co., Ltd.'s LNP-encapsulated COVID-19 mRNA vaccines (OmicronXBB.1.5).

摘要

脂质纳米粒(LNPs)常被用作 mRNA 疫苗的递送载体。LNPs 由四种脂质组成:阳离子脂质、PEG-脂质缀合物、两性离子辅助磷脂和胆固醇。脂质组成显著影响 LNP 的分布效率,也控制 LNP 的稳定性和双层流动性。制剂系统中使用的各种脂质具有不同的性质和含量。为了帮助开发新药和疫苗,我们开发并验证了一种 HPLC-CAD 方法,用于鉴定和测定玉溪沃森生物技术有限公司 LNP 包裹的 COVID-19 mRNA 疫苗(OmicronXBB.1.5)中的四种脂质的含量。

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