使用NMR进行高度蛋白质配方的现场生物物理表征
Jing Song1, Marc Taraban2, Y Bruce Yu2
1Analytical Research and Development, Merck & Co., Inc, Rahway, NJ, USA.
mAbs
|February 1, 2024
概括
水质子核磁共振 (wNMR) 提供了一种分析高度蛋白质药物 (如dupilumab) 的新方法. 这种方法在未经稀释的情况下评估预填注射器中的聚合,与传统技术相对应得很好.
科学领域:
- 生物物理化学 生物物理化学
- 制药科学 制药科学
- 分析化学是一种分析化学.
背景情况:
- 高度蛋白质配方对于以患者为中心的药物开发至关重要,但面临着聚合和粘度等挑战.
- 当前的分析方法往往需要样品转移和稀释,这阻碍了在初级容器中进行直接评估.
- 需要使用非侵入性的现场方法,直接在无菌容器中分析蛋白质药物产品,例如预填注射器.
研究的目的:
- 引入和验证水质子核磁共振 (wNMR) 的新型应用,用于评估蛋白质聚合.
- 在各种压力条件下评估高度蛋白质药物 (Dupixent®,dupilumab) 的聚合倾向.
- 为了证明wNMR的实用性,在初级无菌容器中对蛋白质药物产品进行现场的非侵入性分析.
主要方法:
- 使用水质子核磁共振 (wNMR) 光谱.
- 在压力条件下 (热,结-解) 分析了高度的杜比卢马布配方 (Dupixent®).
- 将wNMR结果与已建立的生物物理分析技术进行比较.
主要成果:
- wNMR揭示了dupilumab在其商业配方中的度依赖的可逆协会.
- 在加快的热应力下观察到不可逆转的聚合,而冷解周期会诱导逐渐可逆的聚合.
- wNMR发现与传统生物物理分析工具的数据有很强的相关性.
结论:
- 水质子核磁共振 (wNMR) 是一种有前途的技术,用于高度蛋白质配方的现场,非侵入性分析.
- 这种方法允许在未经稀释的情况下直接评估初级无菌容器 (如预填注射器) 中的蛋白质聚合.
- wNMR为药物开发和基于蛋白质的治疗方法的质量评估提供了宝贵的见解.
关键词:
加快的压力加速压力.这就是NMR的NMR.生物学的生物学.药物产品的稳定性 药品的稳定性高度的毒品产品是一种药物产品.的 mABs 进行了调试.蛋白质聚合蛋白质的聚合物wNMR是指在一个国家或地区.更多相关视频
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