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相关概念视频

Peptide Identification Using Tandem Mass Spectrometry01:33

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Tandem mass spectrometry, also known as MS/MS or MS2, is an analytical technique that employs two mass analyzers. Essentially it is a series of mass spectrometers that helps isolate a particular biomolecule and then helps study its chemical properties.
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高灵敏度MAM用于支持生物治疗开发过程中的早期活动.

Silvia Millán-Martín1, Anna Mulligan2, Lisa Füssl1

  • 1Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, A94 X099, Ireland.

Journal of chromatography. A
|March 13, 2026
PubMed
概括

一种新的纳米流液体色谱-并联质谱 (LC-MS/MS) 多属性方法 (MAM) 提供了对生物治疗的敏感和强大的描述. 这种方法使早期生物工艺开发和质量控制应用成为可能.

关键词:
关键的质量属性是关键的质量属性.单克隆抗体是一种单克隆抗体.多属性方法多属性方法.没有一个NISTmAbAb.新峰值检测检测的新峰值检测类映射映射 类映射纳米流 LC-MS 的使用.

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科学领域:

  • 生物制药学分析
  • 分析化学 分析化学
  • 质谱测量质量谱测量

背景情况:

  • 为早期生物治疗开发开发敏感的分析方法是具有挑战性的,因为产品知识和样本可用性有限.
  • 强大的方法对于候选人选,流程开发,配方和稳定性研究至关重要.

研究的目的:

  • 提出一种高灵敏度的多属性方法 (MAM),使用纳米流LC-MS/MS来表征基于单克隆抗体 (mAb) 的分子.
  • 评估该方法在检测和量化产品质量属性 (PQAs) 和杂质方面的性能.

主要方法:

  • 采用纳米流液体色谱-并联质谱法 (LC-MS/MS) 进行高分辨率分析.
  • 在符合CFR第11部分的数据系统中使用基于Orbitrap的质量检测.
  • 评估运行到运行变化,灵敏度 (LOD/LOQ) 和新峰值检测 (NPD) 能力.

主要成果:

  • 通过使用NISTmAb作为参考来证明关键分析参数的低运行到运行变化.
  • 获得高灵敏度 (LOD/LOQ:0.6-7.0 ng) 来检测低丰度的PQAs,如除化和氧化.
  • 成功地应用了纳米流MAM用于在工艺过程中监测PQAs和杂质的仿真IgG1mAb.

结论:

  • 纳米流MAM是一种敏感且强大的方法,用于生物治疗特征.
  • 该方法适用于早期生物工艺开发,为质量控制 (QC) 应用提供了潜力.
  • 在过程中测试时,NPD能力有助于检测低级杂质.