移动亲和选择染色学治疗单克隆抗体的分析
Meena L Narsimhan1, Jinhee Kim1, Nathan A Morris1
1Novilytic, LLC, 1281 Win Hentschel Boulevard, West Lafayette, Indiana 47906, United States.
Analytical chemistry
|October 26, 2023
概括
这项研究引入了一种快速,单步方法来分析单克隆抗体 (mAb) 的质量,大大简化了样本准备,并减少了关键质量属性的分析时间.
科学领域:
- 生物技术是生物技术.
- 分析化学 分析化学
- 生物制药制造业 生物制药制造业
背景情况:
- 重组治疗单克隆抗体 (mAb) 的质量控制对于监管合规至关重要.
- 目前的方法涉及两步的过程,包括漫长的样本准备和有限的高阶结构分析.
- 局限性包括耗时的样本准备和现有LC-MS方法中缺乏更高阶结构洞察力.
研究的目的:
- 开发一种综合,快速的方法来评估mAbs.的关键质量属性.
- 为了简化mAb质量验证的分析工作流程.
- 为了在整个发现和制造过程中实现更快,更全面的mAb分析.
主要方法:
- 开发一个单步移动亲和选择染色学 (MASC) 方法.
- 整合样本准备和基于分子识别的分析.
- 使用同位素解的MASC列来规避传统的蛋白质A步骤.
主要成果:
- 在10分钟内实现了mAb标位和相对聚合物含量的同时分析.
- 启用光编码,单体聚合物分辨率,量化和检测在一个步骤.
- 通过消除蛋白质A染色学步骤来证明了一种简化样品制备过程.
结论:
- 本文介绍的MASC方法提供了一种显著更快,更综合的mAb质量评估方法.
- 这种快速分析方法在生物制药开发的所有阶段都是有价值的,从发现到制造.
- 通过这种技术,可以加强对变种形成和关键质量属性的持续监测.
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