在单克隆抗体配方中对基贝塔-环氧德 (HPβCD) 和多酸盐的联合作用的调查
Jiayi Huang1, Shiqi Hong1, Lucas Yuan Hao Goh1
1Pharma Applied Sciences, Roquette Asia Pacific Pte Ltd., Singapore 138588, Singapore.
Pharmaceuticals (Basel, Switzerland)
|April 27, 2024
概括
与多酸盐相结合的基贝塔-环氧德克斯特林 (HPβCD) 显著减少单克隆抗体 (mAb) 配方中的聚合和可分辨粒子,改善蛋白质的稳定性.
科学领域:
- 生物制药配方 生物制药配方
- 蛋白质的稳定性 蛋白质的稳定性
- 助剂科学 助剂科学
背景情况:
- 由于固有的局限性,单克隆抗体 (mAbs) 需要稳定的配方.
- 聚酸盐是常见的稳定剂,可以降解并形成杂质.
- 作为一个独立的蛋白质稳定剂,HPβCD已经显示出有前途.
研究的目的:
- 为了研究聚酸盐和HPβCD在mAb配方中的联合作用.
- 评估这种组合对蛋白质聚合和颗粒形成的影响.
- 了解HPβCD与多酸盐之间的相互作用.
主要方法:
- 贝瓦西祖马布和伊皮利穆马布的配方与HPβCD和多酸盐.
- 配方的压力测试 (激发,光,热).
- 测量可见微粒数量. 可见微粒数量的测量.
- 扩散相互作用参数分析.
- 异热定位热度计 (ITC) 和表面张力测量.
主要成果:
- 在压力下,HPβCD显著降低了模型蛋白中的聚合.
- 与商业配方相比,组合的辅助剂显著降低了可见颗粒数量.
- HPβCD减少了蛋白质与蛋白质之间的相互作用.
- ITC发现了80多酸盐和HPβCD之间的弱相互作用.
- HPβCD增强了聚酸盐的表面活性.
结论:
- 结合HPβCD和聚酸盐提供了一种协同方法来增强mAb的稳定性.
- 这种组合为生物制药行业中改善蛋白质配方提供了可行的替代方案.
- 这些发现支持使用HPβCD作为聚酸盐的补充辅助剂.
关键词:
克莱普托斯 (KLEPTOSE) 是一种HPβCD的药物.这是bevacizumab的治疗方法.辅助剂是一种辅助剂.基烯基β-循环环德克斯特林.这里是 ipilimumab 的所在地.这是一种单克隆抗体.聚酸盐是一种聚酸盐.这是一种蛋白质配方.蛋白质的稳定性 蛋白质的稳定性更多相关视频
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