通过HPLC与光检测使用König反应的确定阿达利穆马布
Ryu Mochizuki1, Toshihiko Toida1, Yasumitsu Ogra1
1Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo, Chiba, Chiba, 60-8675, Japan.
Talanta
|October 16, 2024
概括
一种新方法精确量化单克隆抗体 (mAb) 药物,使用体特异性方法与光检测. 这种技术为现有的mAb药品质量控制方法提供了一种可靠且具有成本效益的替代方案.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
- 蛋白质量化量化方法 蛋白质量化方法
背景情况:
- 单克隆抗体 (mAb) 药物是关键的治疗方法,需要精确的质量控制.
- 目前的量化方法 (吸收,ELISA,LC-MS/MS) 在选择性,可靠性或成本方面存在局限性.
- 精确的mAb含量确定对于最大限度地提高治疗效果和最大限度地减少不良影响至关重要.
研究的目的:
- 开发和验证一种新的,具有成本效益的方法来定量单克隆抗体药物.
- 建立一种使用König反应以提高检测灵敏度的代用方法.
- 证明该方法在生物制药产品质量控制中的适用性.
主要方法:
- 采用了代用的方法,针对单克隆抗体特定的.
- 使用氨酸T的后列衍生利用替代的替代产生的化物.
- 产生的化物通过光检测,使用传统LC系统上的König反应.
主要成果:
- 该方法实现了0.31微克/毫升的检测极限 (LOD) 和0.94微克/毫升的定量极限 (LOQ) 的阿达利姆巴.
- 观察到高的日内和日间精度 (例如,50微克的阿达利木马布的精度为101.6%和101.8%) 和精度 (例如,10.2%和6.98%).
- 在Humira®中对阿达利穆马布的量化与指定的值保持一致,验证了该方法的准确性.
结论:
- 与传统技术相比,开发的方法为mAb量化提供了选择性,可靠和成本效益的替代方案.
- 这种方法利用König反应和传统的LC系统,简化了mAb分析而不需要LC-MS/MS.
- 这项研究引入了一种有前途的新代谢策略,用于蛋白质和mAb药物的确定.
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