Zhao Hengzhi, Li Wendong, Liu Jingjing, Li Xiao, Ji Hong, Hu Mo, Li Min
NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs, Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing 102206, China.
Changping Laboratory, Beijing 102206, China.
Vaccines (Basel). 2024 Sep 15;12(9):1055. doi: 10.3390/vaccines12091055.
A nanoliter liquid chromatography-high resolution mass spectrometry-based method was developed for quantitative proteomics analysis of COVID-19 vaccines. It can be used for simultaneous qualitative and quantitative analysis of target proteins and host cell proteins (HCPs) in vaccine samples. This approach can directly provide protein information at the molecular level. Based on this, the proteomes of 15 batches of COVID-19 inactivated vaccine samples from two companies and 12 batches of COVID-19 recombinant protein vaccine samples from one company were successfully analyzed, which provided a significant amount of valuable information. Samples produced in different batches or by different companies can be systematically contrasted in this way, offering powerful supplements for existing quality standards. This strategy paves the way for profiling proteomics in complex samples and provides a novel perspective on the quality evaluation of bio-macromolecular drugs.
开发了一种基于纳升液相色谱-高分辨率质谱的方法用于新冠疫苗的定量蛋白质组学分析。它可用于同时对疫苗样品中的目标蛋白和宿主细胞蛋白（HCPs）进行定性和定量分析。这种方法能够在分子水平直接提供蛋白质信息。基于此，成功分析了来自两家公司的15批次新冠灭活疫苗样品和来自一家公司的12批次新冠重组蛋白疫苗样品的蛋白质组，提供了大量有价值的信息。以这种方式可以系统地对比不同批次或不同公司生产的样品，为现有质量标准提供有力补充。该策略为复杂样品的蛋白质组分析铺平了道路，并为生物大分子药物的质量评估提供了新的视角。
