一个多实验室,多平台分析多属性方法的分析
Joshua Shipman1, Mercy Oyugi1,2, Tim Andres Marzan1
1Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA.
Pharmaceuticals (Basel, Switzerland)
|November 27, 2025
概括
多属性方法 (MAM) 显示出在生物制药分析中取代传统质量控制 (QC) 方法的潜力. 跨实验室和仪器的验证证实了它对量化治疗蛋白质属性的能力.
科学领域:
- 生物制药学分析
- 分析化学 分析化学
- 蛋白质的表征 蛋白质的表征
背景情况:
- 多属性方法 (MAM) 越来越多地用于描述治疗性蛋白质.
- 过渡MAM到质量控制 (QC) 需要方法能力评估和风险分析.
研究的目的:
- 评估经过验证的MAM对量化产品质量属性 (PQA) 的能力.
- 为了比较MAM性能与传统色谱法 (HILIC-FLD,CEX-UV) 的性能.
- 评估MAM可转移性的仪器间和实验室间变异性.
主要方法:
- 采用了经过验证的MAM方法.
- PQA的量化包括糖化,脱化,氧化和N-/C-termini.
- 与水友交互色谱-光检测 (HILIC-FLD) 和阳离子交换色谱-紫外线 (CEX-UV) 的比较.
主要成果:
- 在各种稳定性条件下 (压力,长期,加速) MAM成功量化了PQA.
- 仪器间和实验室间的数据证明了MAM的一致性.
- 确定了MAM和传统方法之间的相关性.
结论:
- 该研究为将MAM转移到QC环境提供了必要的数据.
- MAM显示有可能取代正交的QC方法,提高效率.
- 方法的可转移性和相关性是QC采用的关键.
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