多层―完整,子单元和―通过单列LC-MS设置对抗体基治疗药物的表征
Kia-Ngee Low1, Yee-Jiun Kok1, Stephen Tate2
1Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR), 20 Biopolis Way, #06-01 Centros, Singapore 138668, Singapore.
Analytical chemistry
|February 25, 2025
概括
本研究引入了一种精简的单列液体染色体质谱法 (LC-MS) 方法,用于全面的生物治疗蛋白质表征. 该方法使得可靠的中间分析和有效评估产品质量属性 (PQA) 成为可能.
科学领域:
- 分析化学 分析化学
- 生物化学 生物化学
- 生物技术是生物技术.
背景情况:
- 监管任务要求对生物治疗药物进行全面的多层次表征.
- 传统的质谱法 (MS) 分析包括完整的蛋白质,中向上和自下而上的分析,通常需要多个列.
- 中下MS和逆相液态染色学 (LC) 的进步为简化工作流提供了机会.
研究的目的:
- 开发和评估一个强大的中向下LC-MS方法用于生物治疗蛋白质的表征.
- 评估单列C4LC-MS设置用于治疗蛋白质的多层次分析.
- 为了证明产品质量属性 (PQA) 评估的简化方法的效率和全面性.
主要方法:
- 使用ZenoTOF 7600仪器开发一个中向下的LC-MS方法.
- 对LC-MS分析的C4列的评估.
- 该方法用于完整的蛋白质,NISTmAb,双特异抗体 (bsAb) 和etanercept的中上/下,和自下而上的分析.
主要成果:
- 使用C4LC-MS设置成功对治疗性蛋白质进行了多层次的表征.
- 通过自下而上的C4 LC-MS实现了高序列覆盖率和全面的翻译后修改概况.
- 乙太子单元中下分析的第一份报告和糖化位点的详细地图.
结论:
- 一个精简的单列LC-MS设置使生物治疗药物的强大和高效的多层次表征成为可能.
- 开发的方法有助于进行全面的PQA评估,包括复杂的糖化化分析.
- 这种方法简化了LC-MS作为生物制药应用程序的过程分析技术的集成.
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