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纳米材料内毒素污染评估的实验室间比较

Gary Hannon^1,2, Bethany J Heaton^3,4, Alexander Plant-Hately^3,4

¹Nanomedicine and Molecular Imaging Group, Department of Clinical Medicine, Trinity Translational Medicine Institute, Trinity College Dublin, Dublin, Ireland. prinamea@tcd.ie.

|October 24, 2024

概括

纳米材料中的内毒素污染是生物医学使用的一个主要挑战. 实验室间测试显示了检测的显著变异性,影响了监管合规性和研究有效性.

科学领域:

生物医学工程生物医学工程
纳米技术纳米技术
分析化学分析化学

背景情况:

内毒素污染对纳米材料的临床转化构成了重大障碍.
超过三分之一的纳米材料由于无法接受的内毒素水平而未能通过临床前评估.
许多现有的免疫学和体内研究遗漏了内毒素评估,可能导致不准确的结果.

研究的目的:

对各种纳米材料进行内毒素污染评估方法的实验室间比较.
评估当前国际标准 (ISO和药典) 对存在纳米材料的内毒素测试的可靠性.

主要方法:

设计了一项涉及多个评估组的实验室间比较研究.
通过使用标准方法,对一系列纳米材料进行了内毒素污染测试.
应用了医疗器械的质量标准和监管限制.

主要成果:

检测到的内毒素水平在参与实验室之间有很大差异.
一些纳米材料通过和失败了监管限制,这取决于评估组.
尽管纳米材料符合所有质量标准标准,但仍存在变化.

结论:

目前的内毒素评估方法不足以进行可靠的纳米材料表征.
为了准确确定纳米材料中的内毒素水平,需要进行多次测定.
开发新的,耐干扰的内毒素检测试验对生物医学应用至关重要.

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