使用离子液体的超高度低粘度皮下抗体配方使用离子液体
Anujan Ramesh1, Metecan Erdi1, Shuyang Zhang1
1Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Allston, MA 02134, USA.
概括
离子液体使得超高度单克隆抗体 (mAb) 配方能够超过200mg/ml. 这些新的皮下配方提供了更好的稳定性和生物可用性,解决了治疗交付的未满足需求.
科学领域:
- 生物技术是生物技术.
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 单克隆抗体 (mAbs) 是瘤学,免疫学和神经学治疗的主要类别.
- 目前的皮下mAb配方由于蛋白质与蛋白质相互作用而面临限制,将度限制在150mg/ml左右.
- 开发高度,低粘度和稳定的皮下mAb配方是一个至关重要的未满足需求.
研究的目的:
- 研究使用离子液体 (ILs) 制备超高度单克隆抗体.
- 评估ILs对抗体稳定性,粘度和皮下施用生物可用性的影响.
主要方法:
- 使用特定的离子液体 (ILs) 制备单克隆抗体 (IgG).
- 对IgG-IL配方的度,粘度和在不同温度下的稳定性进行表征.
- 与盐水相比,IgG-IL配方的皮下生物利用率的评估.
主要成果:
- 离子液使抗体在超过200毫克/毫升的度下形成.
- IgG-IL配方的粘度保持在可注射值以下 (<20cP).
- 配方在室温和37°C时表现出稳定性,皮下生物可用性得到改善.
结论:
- 离子液是有效的减轻蛋白质-蛋白质相互作用的超高度的mAb配方.
- 基于IL的配方为治疗性抗体的稳定,低粘度的皮下输送提供了有希望的方法.
- 这项技术解决了mAb配方的关键挑战,有可能提高治疗疗效和患者的便利性.
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