一种新的深场扫描液体染色体质谱法方法,用于识别治疗蛋白中的宿主细胞蛋白质
Leo Wang1, Chris Barton1, Yan Wang1
1Analytical Development, Pharmaceutical Sciences, Takeda Development Center Americas, Inc., 200 Shire Way, Lexington, MA 02421, United States.
Journal of pharmaceutical and biomedical analysis
|September 30, 2025
概括
一种新的深野扫描LC-MS/MS方法改善了在生物制品中检测宿主细胞残留蛋白质 (HCPs). 这种方法可以在没有样本准备的情况下增强HCP识别,为治疗性蛋白质开发提供了一种多功能工具.
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:
- 剩余宿主细胞蛋白 (HCP) 是治疗性蛋白质中的关键杂质,由于其稀少性和广泛的动态范围,其检测具有挑战性.
- 准确的HCP检测对于确保生物药物的安全性和有效性至关重要.
研究的目的:
- 开发和验证一种增强的液体染色体双重质谱法 (LC-MS/MS) 方法,以改进HCP检测.
- 为了证明该方法对单克隆抗体 (mAbs) 和非mAb生物的适用性.
主要方法:
- 在Thermo Orbitrap AcquireX平台上开发一种"深野扫描"LC-MS/MS方法,使用自动化,累积的目标质量排除列表和代数据采集.
- 通过减少冗余样采样和提高MS/MS光谱质量来优化MS效率.
- 该方法应用于NISTmAb,并与传统的前10个数据依赖采集 (DDA) 进行比较.
主要成果:
- 深野扫描方法在HCP检测方面表现出优异的性能,与NISTmAb.Ab的传统DDA相比.
- 该方法成功地识别了医疗保健人员,无需进行样本丰富或清理.
- 从商业抗体标准建立了一个基准的HCP库,供社区使用.
结论:
- 开发的深野扫描LC-MS/MS方法为生物学中HCP表征提供了一个自动化,可适应和高效的工作流.
- 这一进步支持更全面的数据收集,并改善了治疗性蛋白质开发中的杂质分析.
- 该方法与各种治疗方式的兼容性扩大了其在生物制药行业的实用性.
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