开发,资格和应用一个高效和强大的新的峰值检测工作流程,用于LC-MS片映射多属性方法的开发,资格和应用.
Thomas Pohl1, Patrick Sascha Merkle1, Sonja Hudelmaier1
1Biologics Analytical Development, Technical Research & Development, Novartis Pharma AG, Basel, Switzerland.
mAbs
|October 14, 2025
概括
本研究引入了一种新的峰值检测 (NPD) 工作流程,用于多属性方法 (MAM) 映射. 这种强大的方法可靠地识别生物制药中的关键变化,增强药品质量控制.
科学领域:
- 生物制药学分析
- 分析化学 分析化学
- 质量控制 质量控制 质量控制
背景情况:
- 使用液体染色学-质谱学图的多属性方法 (MAM) 为蛋白质生物制药的传统纯度/不纯度测定提供了一个有希望的替代方案.
- 可靠检测新的,缺席的或改变的物种对于确保药物的质量,安全性和疗效至关重要,需要先进的新峰检测 (NPD) 能力.
研究的目的:
- 开发,合格和应用一个高效和强大的NPD工作流程用于MAM片映射.
- 根据ICH Q2指南验证NPD工作流程,以可靠地检测生物制药中的杂质.
主要方法:
- 在Genedata Expressionist®软件中开发和实施新峰值检测 (NPD) 工作流.
- 根据ICH Q2指南,合理设计检测值和验证NPD工作流程.
- 将工作流应用于药物产品的稳定性测试和药物物质中未知杂质的检测.
主要成果:
- 开发的NPD工作流可靠地检测出相对丰度低于1%的相关类.
- 该工作流显示出高效率和稳定性,成功识别了关键变化,而没有报告错误的阳性峰值.
- 案例研究证实了工作流在稳定性测试和药物物质中识别未知杂质方面的能力.
结论:
- 经过验证的NPD工作流程代表了MAM用于蛋白质生物制药品质量控制的重大进步.
- 这种方法能够灵敏且可靠地识别真正的阳性峰值,改善药物质量,安全性和疗效的评估.
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