尺寸排除色谱作为强制降解研究的绿色支持阿达利穆马布的强制降解研究
Jelena Kovačić1, Daniela Amidžić Klarić1, Nikša Turk2
11University of Zagreb, Faculty of Pharmacy and Biochemistry Department of Pharmaceutical Analysis, 10000 Zagreb, Croatia.
Acta pharmaceutica (Zagreb, Croatia)
|December 26, 2023
概括
高级尺寸排除色谱 (SEC) 有效地分析了阿达利穆马布的降解,在酸性和性条件下识别了抗体碎片作为主要产物. 这种方法为生物药物提供了环保的分析.
科学领域:
- 生物制药学分析分析
- 染色学技术 染色学技术的使用
- 蛋白质降解研究的研究.
背景情况:
- 尺寸排除色谱 (SEC) 对于分析生物药物尺寸变异至关重要.
- 现代SEC使用3μm以下的粒子列来提高吞吐量.
- 阿达利穆马布是一种人性化的IgG1单克隆抗体,是关键的生物治疗药物.
研究的目的:
- 为了评估高级SEC与亚-3微米颗粒的阿达利穆马布降解路径阐明.
- 为了确定阿达利穆马布的主要降解产物.
- 评估强制降解程序对环境的影响.
主要方法:
- 强制降解研究的阿达利穆马布.
- 分析使用具有3微米以下颗粒的先进SEC列.
- 使用AGREE和AGREEprep计算器进行环境绩效评估.
主要成果:
- 抗体碎片被确定为阿达利穆马布的主要降解产物.
- 酸性和性条件显著影响了阿达利穆马布的降解.
- 在热和光解应激下,阿达利穆马布表现出相对稳定.
- 强制降解程序显示了环保条件,绿色分数为0.81和0.61.
结论:
- 先进的SEC是一种强大的工具,用于表征生物药物降解.
- 酸性和基本性条件是阿达利穆马布不稳定性的关键因素.
- 描述的方法是环保的,与绿色化学原则保持一致.
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