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基于受控降解研究的布罗利祖马布的综合物理化学和功能分析:对抗原-抗体结合的影响

Anabel Torrente-López¹, Jesús Hermosilla¹, Antonio Salmerón-García²

¹Department of Analytical Chemistry, Science Faculty, Biohealth Research Institute (ibs.GRANADA), University of Granada, E-18071 Granada, Spain.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|December 15, 2023

概括

佩布罗利祖马布 (Keytruda) 的稳定性受到热量和光线暴露的影响,影响其与PD-1结合的能力. 谨慎处理对于维持这种单克隆抗体疗法的疗效至关重要.

科学领域:

生物化学生化学
生物物理学的生物物理.
制药科学制药科学

背景情况:

单克隆抗体疗法,如布罗利祖马布,对环境条件敏感.
正确的处理对于确保这些敏感药物的安全性和有效性在临床环境中至关重要.

研究的目的:

为了研究pembrolizumab在各种压力条件下的物理化学和功能稳定性.
了解pembrolizumab在日常处理和医院潜在的错误处理中的风险行为.

主要方法:

进行了受控的降解研究,包括热,结/解,振动,加速光照和高压溶液.
使用远紫外CD,IT-FS,DLS,RP/UHPLC(UV) -MS,SE/UHPLC(UV),RP/UHPLC(UV) -MS/MS和ELISA等分析技术来评估关键质量属性.

主要成果:

加快光线暴露和60°C的热量显著影响了pembrolizumab,导致非自然的二分体和高分子量物种 (HMWS).
暴露于光线也改变了异形状的形状,并增加了氧化水平.
所有压力因素都降低了pembrolizumab对PD-1受体的结合能力,其中60°C和光线暴露具有最显著的影响,尽管生物活性仍然很高.

结论:

布罗利祖马布对光线和高温敏感,影响其结构完整性和抗原结合功能.
这些发现强调了特殊的储存和处理条件的重要性,以保持pembrolizumab的质量.
对单克隆抗体稳定性的进一步研究对于优化治疗结果至关重要.

关键词:

综合的分析性质表征.强制降解研究强制降解研究在使用中的稳定性.这就是Pembrolizumab.在 UHPLC-MS/MS 中,的映射.

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