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根据短期降解动力学预测长期的聚酸盐降解

Sisi Zhang¹, Caterina Riccardi², Dane Carlson²

¹Analytical Chemistry, Regeneron Pharmaceuticals, Tarrytown, NY, USA.

|July 7, 2023

概括

一个新的平台预测了抗体药物中多酸盐20 (PS20) 和多酸盐80 (PS80) 的长期降解. 该方法使用短期研究来确保配方稳定性并防止蛋白质聚合.

科学领域:

制药科学制药科学
生物化学生化学
化学工程是化学工程的重要组成部分.

背景情况:

聚酸盐 (PSs) 是蛋白质治疗配方中至关重要的辅助成分,防止变质和聚合.
PSs的降解可能导致蛋白质稳定性丧失,导致关键质量属性变化,如颗粒形成.

研究的目的:

开发一个简化,加速的平台,用于预测单克隆抗体 (mAb) 药物中多酸盐20 (PS20) 和多酸盐80 (PS80) 的长期降解.
通过短期动力学研究,在较长时间 (长达2年) 中准确预测PS降解.

主要方法:

根据现有的稳定性数据,开发了PS20和PS80降解的温度依赖的预测方程.
利用短期动力学研究 (在2周内) 来收集预测模型的数据.
验证了平台在预测PS20和PS80水解的准确性,在2年的时间范围内.

主要成果:

使用开发的平台,高达2年的PS20和PS80水解的准确预测.
证明短期动力学研究可以可靠地预测长期的多酸盐稳定性.
该平台显著减少了在mAb配方中的聚酸盐长期稳定性评估所需的时间.

结论:

简化平台提供了一种时间效率高的方法,用于预测抗体配方中的长期聚酸盐降解.
这种方法有助于指导净化过程和优化抗体药物配方,以提高稳定性.
加速稳定性预测对于确保基于蛋白质的治疗药物的质量和疗效至关重要.

关键词:

自由脂肪酸是自由的脂肪酸.脂酶活性激酶的活性长期稳定的长期稳定性聚酸盐的水解过程短期动力学短期动力学

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