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

IF 2.2 4区 医学 Q3 BIOCHEMICAL RESEARCH METHODS Journal of virological methods Pub Date : 2024-10-09 DOI:10.1016/j.jviromet.2024.115040
Huan Yang , Chengrui Fei , Sijie Wang , Xue Shen , Li Yang , Hefeng Yang , Guiding Li
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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).
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验证测量新型 LNP 封装 COVID-19 mRNA 疫苗脂质含量的 HPLC-CAD 方法。
脂质纳米颗粒(LNPs)经常被用作 mRNA 疫苗的输送载体。LNP 由四种类型的脂质组成:阳离子脂质、PEG-脂质共轭物、齐聚辅助磷脂和胆固醇。LNP 的分布效率受脂质成分的影响很大,脂质成分还控制着 LNP 的稳定性和双分子层的流动性。制剂系统中使用的各种脂质具有不同的特性和含量。为了帮助新药和疫苗的开发,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科技有限公司的 LNP 封装 COVID-19 mRNA 疫苗(OmicronXBB.1.5)中四种脂质的含量。
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来源期刊
CiteScore
5.80
自引率
0.00%
发文量
209
审稿时长
41 days
期刊介绍: The Journal of Virological Methods focuses on original, high quality research papers that describe novel and comprehensively tested methods which enhance human, animal, plant, bacterial or environmental virology and prions research and discovery. The methods may include, but not limited to, the study of: Viral components and morphology- Virus isolation, propagation and development of viral vectors- Viral pathogenesis, oncogenesis, vaccines and antivirals- Virus replication, host-pathogen interactions and responses- Virus transmission, prevention, control and treatment- Viral metagenomics and virome- Virus ecology, adaption and evolution- Applied virology such as nanotechnology- Viral diagnosis with novelty and comprehensive evaluation. We seek articles, systematic reviews, meta-analyses and laboratory protocols that include comprehensive technical details with statistical confirmations that provide validations against current best practice, international standards or quality assurance programs and which advance knowledge in virology leading to improved medical, veterinary or agricultural practices and management.
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