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lysophosphatidylcholine作为亲肠道单克隆抗体配方的界面稳定剂

Eleni Papadopoulos¹, Betharie Cendera Arrahmani², Katharina Beck³

¹Ludwig-Maximilians-Universität München, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Butenandtstraße 5-13 B, 81377 Munich, Germany.

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

|September 27, 2024

概括

lysophosphatidylcholines (LPCs) 显示出作为治疗性蛋白质配方的替代表面活性剂的希望. 它们有效地防止在机械应力下单克隆抗体颗粒的形成,类似于聚酸盐.

科学领域:

制药科学制药科学
生物化学生物化学
材料科学材料科学材料科学

背景情况:

治疗性蛋白质需要在水溶液中稳定,以防止聚合和颗粒形成.
聚酸盐和酸盐是常见的表面活性剂,但聚酸盐可以降解,导致不稳定性和蛋白质氧化.
与聚酸盐相比,波洛克萨默在防止蛋白质聚合方面效果较差.

研究的目的:

研究 lysophosphatidylcholines (LPCs) 作为蛋白质配方的替代表面活性剂.
评估LPCs对单克隆抗体 (mAb) 粒子形成的物理化学行为和保护能力.
评估LPCs在血液溶解活性方面的安全概况.

主要方法:

经过测试的mAb配方中的LPC受到机械应力 (震动,周围静止) 的影响.
在血缓冲混合物中评估LPCs的溶血活性.
使用的分析方式包括张力测量,扩展性脊髓学,多角度光散射和异热定位热量测量.
通过子相交换实验,评估表面活性剂的脱落和再吸收动态.

主要成果:

在机械应力过程中,LPCs有效地稳定了mAb配方,防止粒子形成,可与聚酸盐80和波洛克萨默188.8相比.
稳定所需的LPC度明显低于导致血液溶解的水平,这表明安全性概况有利.
稳定性归因于在临界微粒度 (CMC) 时形成粘弹性膜.
LPCs被证明迅速重新吸收到散装溶液中,防止蛋白质吸附到接口.

结论:

lysophosphatidylcholines (LPCs) 是治疗性蛋白质配方的有效稳定剂,可以防止在机械应力下形成颗粒.
在有效度下,LPCs表现出良好的安全性,具有最小的溶血活性.
由于它们的界面稳定性,LPCs在亲肠道蛋白质配方中显示出作为聚酸盐可行的替代品的潜力.

关键词:

辅助物质辅助物质辅助物质液体-空气接口液体空气接口莱索-酸胆是一种酸.亲肠道配方可以使用.粒子形成的过程聚酸盐的降解降解蛋白质聚合蛋白质的聚合.蛋白质稳定蛋白质稳定治疗性蛋白质治疗性蛋白质

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