在疫苗中使用SEAP报告者细胞系检测细胞杂质和NF-κB激活
Sarah K Mercier1, Georgia Gilmayer1, Jackson Williams2
1Health Products Regulation Group, Therapeutic Goods Administration, 1 Tindal Lane Fairbairn, Australian Capital Territory, Australia 2609.
Journal of virological methods
|February 20, 2026
概括
一种新的测定方法可靠地检测到疫苗中的核因子卡巴-β (NF-κB) 激活,解决了安全问题. 该方法支持疫苗质量控制和监管审查,以改善公共卫生.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 分析化学 分析化学
背景情况:
- 儿童发烧的不良事件信号与季节性三价疫苗激活NF-κB有关.
- 澳大利亚治疗用品管理局 (TGA) 要求在疫苗样本中检测NF-κB激活的方法.
研究的目的:
- 建立和验证一种可靠的分析方法,用于检测疫苗成分对NF-κB的激活.
- 支持疫苗制造商和监管机构对杂质进行查和表征.
主要方法:
- 使用了表达托尔类受体 (TLR) 的记者细胞系 (THP1-Blue,Ramos-Blue) 和QUANTI-BlueTM系统.
- 使用TLR激动剂,瘤缩因子-α (TNF-α) 和疫苗样本检测到TLR1-9的激活.
主要成果:
- 已证实细胞系对细胞外 (THP1-Blue) 和内体 (Ramos-Blue) TLR激活的特异性.
- 在各种疫苗类型 (病毒,mRNA,细菌) 中证明了测试线性,精度和准确性 (恢复80-120%).
结论:
- 建立了一种经过验证,敏感和可靠的测定方法,用于检测生物活性疫苗成分对NF-κB的激活.
- 该试验有助于对激活NF-κB通路的疫苗进行杂质查,未来需要进行研究以进行更广泛的表征.
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相关概念视频
NF-κB-dependent Signaling Pathway
The transcription factor NF-κB was discovered in 1986 in the lab of Nobel laureate Professor David Baltimore, for its interaction with the immunoglobulin light chain enhancer in B-cells. After more than three decades of study, it is now evident that NF-κB regulates the expression of over 100 genes. Most of these genes play an essential role in the innate and adaptive immune responses as well as the inflammatory responses of animals.
NF-κB-dependent Signaling Mechanism
The heterodimer of NF-κB...
NF-κB-dependent Signaling Mechanism
The heterodimer of NF-κB...
Reporter Genes
Reporter genes are a type of protein-coding gene that are often tagged to a gene of interest. Once inside a target cell, reporter genes usually produce visually identifiable characteristics like fluorescence and luminescence when expressed along with the gene of interest. Thus, reporter genes “report” the presence or absence of genes of interest in an organism, determine the gene expression pattern, or track the physical location of a DNA segment or protein in the cell.
Commonly used reporter...
Commonly used reporter...
