生物药物产品开发中的两个压力因素的故事:震动模式和初级包装
Siddhanth Hejmady1, Elham Taherian1, Reza Nejadnik2
1Department of Pharmaceutical Sciences and Experimental Therapeutics, 446, College of Pharmacy Building (CPB), University of Iowa, 180 S. Grand Ave, Iowa City, 52242, IA, USA.
Pharmaceutical research
|November 18, 2025
概括
水平振动比轨道振动更好地检测单克隆抗体 (mAb) 聚合. 玻璃瓶表面的化学成分对mAb的稳定性有很大的影响,尤其是在没有聚酸盐80 (PS80) 的情况下,这凸显了改进应力测试模型的必要性.
科学领域:
- 生物制药开发 生物制药开发
- 蛋白质的稳定性 蛋白质的稳定性
- 配方科学科学 配方科学
背景情况:
- 在生物处理过程中,机械,接口和剪切应力会降低单克隆抗体 (mAb) 的稳定性.
- 当前的缩放式振动模型往往忽视了固体-液体接口,限制了它们在预测现实世界的压力条件方面的有效性.
- 了解这些压力对于强大的药物产品开发和确保治疗疗效至关重要.
研究的目的:
- 为了研究不同摇动方法 (水平与轨道) 对mAb聚合的影响.
- 评估瓶表面化学在机械应力下蛋白质聚合中的作用.
- 为早期产品开发和运输模拟确定更有效的压力测试模型.
主要方法:
- 在水平和轨道震动下,对 Cetuximab 和 Tocilizumab 配方 (含/不含 80 聚酸盐) 的聚合概况进行比较.
- 使用直角技术评估蛋白质聚合:尺寸排除色谱,动态光散射,流影像显微镜,UV-Vis光谱和视觉检查.
- 研究了未经处理的玻璃瓶与化玻璃瓶在水平动下对Cetuximab聚合的影响.
主要成果:
- 在识别Cetuximab对聚合的易感性方面,水平震动比轨道震动更有效.
- 与未经处理的瓶子相比,疏水性化瓶子增加了没有聚酸盐80的Cetuximab聚合.
- 与玻璃瓶相比,聚酸盐80的塞图西马布在化瓶中显示出较低的聚合.
结论:
- 调动模型的选择对于在mAb开发中精确的压力选至关重要.
- 玻璃瓶表面与液体的接口在压力下蛋白质聚合中起着重要作用.
- 探索"三重接口" (蛋白质,液体,瓶表面) 对于提高压力测试方法至关重要.
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