在全球质量控制网络中使用质谱测量进行强大的身份释放测试.
Sebastien Leibe1, Sebastien Violini1, Moritz Vollrath1
1Pharma Technical Development Analytics, F. Hoffmann-La Roche, Basel, Switzerland.
mAbs
|March 10, 2026
概括
罗氏/Genentech开发了一种基于质谱的方法,用于生物制品的产品身份测试. 这种强大,自动化的平台增强了质量控制,减少了错误,并允许对产品变体进行详细分析.
科学领域:
- 制药品质量控制 制药品质量控制
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 产品身份 (ID) 测试对于制药质量控制至关重要.
- 现有的方法可能需要广泛的验证,容易出现错误.
- 生物制剂需要严格的测试来确保安全性和有效性.
研究的目的:
- 建立基于质谱的平台ID方法,用于生物制剂的常规释放测试.
- 为质量控制环境开发一种自动化和用户友好的方法.
- 加强对产品变体的评估,并支持根本原因分析.
主要方法:
- 片映射与液体染色学质谱学 (LC-MS) 结合.
- 用于例行释放测试的自动化数据评估.
- 在全球临床和商业质量控制环境中应用.
主要成果:
- 该LC-MS基映射方法是强大的和用户友好的.
- 显著减少了新生物产品的验证工作.
- 在测试执行和数据评估中降低了错误率.
- 化学和翻译后修饰的敏感,高分辨率的评估.
结论:
- 已建立的质谱平台可以改善产品监测.
- 来自ID测试的数据可以重新评估质量影响评估.
- 这项技术简化了根本原因分析和故障缓解.
- 在所有罗氏/Genentech质量控制站点获得资格,以加强生物监测.
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