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用质谱测量对过敏原产品的质量控制第一部分:在欧盟监管框架内定位

Jelena Spiric¹, Thomas Schulenborg¹, Thomas Holzhauser¹

¹Allergology Division, Central Method Development Section, Paul-Ehrlich-Institut, Langen, Germany.

|March 1, 2024

概括

质谱 (MS) 为过敏原产品标准化和监管使用提供了先进的应用. 这项技术可以补充或取代现有的过敏原检测和量化方法.

科学领域:

分析化学分析化学
生物技术是生物技术.
监管科学监管科学

背景情况:

质谱学 (MS) 已取得重大进展,在过敏原产品的监管程序中具有潜在的应用.
对过敏原产品的标准化带来了一些挑战,MS可能有助于克服这些挑战.
目前的监管指南提到MS作为一种可能的测量方法,但缺乏具体的协议.

研究的目的:

在欧盟对过敏原产品的监管框架内讨论质谱学 (MS) 的应用.
评估MS的优点和缺点与既定方法相比.
探索MS在研究,表征,制造商发布分析和官方批量测试中的作用.

主要方法:

在欧盟监管框架内讨论MS应用程序.
分析MS用于单个和多个过敏原的定性检测 (身份证明).
对成员国进行质量或半量蛋白质分析 (批量一致性) 和量化 (质量单位) 的评估.

主要成果:

对于纯化蛋白质,MS应用已经很成熟,但对于复杂的过敏原产品,应用仍在发展.
MS可用于过敏原识别,一致性测试和量化.
国家有潜力促进过敏原产品,参考产品和参考标准的标准化.

结论:

质谱 (MS) 对提高过敏原产品的标准化和监管合规性具有显著的前景.
需要进一步开发并将特定的MS方法纳入监管指南中.
MS可以作为一个有价值的工具跨越各种阶段,从研究到官方批量测试,提高过敏原产品的质量和一致性.

关键词:

过敏原质量单位的质量单位.过敏原标准化标准化批量测试批量测试批量测试一致性测试是一致性测试.质谱测量质谱测量质谱测量质谱测量质量测量质谱测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量质量测量

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