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集成的本地消化和分子量切断缩与DIA-MS:一种敏感和选择性的方法,用于定量分析的HCP

Yachuan Gong¹, Yanjia Zhao¹, Rui Peng¹

¹Wuya College of Innovation, Shenyang Pharmaceutical University, Shenyang, Liaoning, 110016, PR China.

|November 4, 2025

概括

持续监测宿主细胞残留蛋白质 (HCP) 对生物制药安全至关重要. 这项研究提出了一个新的工作流程,用于在净化过程中敏感的HCP检测和跟踪,提高药物安全性和流程优化.

科学领域:

生物制药制造业生物制药制造业
分析化学分析化学
蛋白质组学是指蛋白质组学.

背景情况:

生物制药中的残留宿主细胞蛋白 (HCP) 可以降低药物的疗效,并构成患者安全风险.
在净化过程中,精确的HCP监控对于质量控制至关重要.
现有的方法在治疗蛋白质和医疗人员之间的广泛动态范围中扎.

研究的目的:

开发一种创新的工作流程,用于在生物制药净化过程中敏感检测和持续监测HCP.
为了克服传统液态色谱-质谱法方法的动态范围限制.
为了能够实时跟踪关键杂质,如高风险蛋白质PLBD2.2.

主要方法:

集成的工作流程,结合了两阶段的本地消化和分子量切断过,用于HCP丰富.
数据独立采集数据采集的质谱.
频谱探测器软件用于光谱图书馆的构建和数据处理.
消除传统的治疗性蛋白质预分离步骤.

主要成果:

医疗人员的敏感检测降至每百万分之0.5 (ppm).
启用了关键杂质的持续定量跟踪,包括高风险蛋白质PLBD2.
与ELISA相比,已经证明了更高的灵敏度和特异性.
验证的方法符合生物分析要求.

结论:

开发的工作流提供了敏感和强大的HCP检测,用于实时监测抗体净化.
这种方法支持生物制药过程的优化,并提高了患者的安全.
该方法克服了由于动态范围差异导致的HCP分析的先前限制.

关键词:

时间时间时间时间医疗保健工作人员的医疗保健工作人员.在MWCOCO上,量化量化量化量化

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