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在双特异抗体生物类似物中通过组合调节器调节N-糖化
Xu Shengnan1, Wang Pan1, Wang Xiaofei1
1Nanjing Chia Tai-Tianqing Pharmaceutical Co Ltd, Fanghua Pharmaceutical Research Institute, Department of Biology, Nanjing, 210046, China.
Protein expression and purification
|September 28, 2025
概括
在生物类似双特异抗体 (BsAbs) 中优化糖化是相似性的关键. 使用银河糖和三甲氨基甲 (Tris) 有效调节N-甘氨酸,而不会影响细胞生长或纯度.
科学领域:
- 生物技术是生物技术.
- 生物制药制造业 生物制药制造业
- 葡萄糖科学 (Glycoscience) 是一种科学.
背景情况:
- 确保与参考药物的生物相似性需要精确控制糖化.
- 双特异性抗体 (BsAbs) 是复杂的生物制剂,其中糖化对有效性有显著影响.
- 优化N-甘氨酸的形状对于治疗性蛋白质的一致性至关重要.
研究的目的:
- 为了优化双特异抗体 (BsAb) 的糖化概况,生物类似物.
- 为了达到与参考药物紧密相匹配的糖基化概况.
- 评估糖系化调节器的协同效应.
主要方法:
- 对银河糖 (Gal) 和化 (MnCl2) 度进行选,以进行银河糖化.
- 评估氨基甲 (Tris) 对曼诺和富可的纳入的影响.
- 评估同步调节器对N-甘氨酸配置,细胞生长,新陈代谢和纯度的影响.
主要成果:
- 同时使用Tris和银河糖调节的N-甘氨酸有效.
- 没有观察到对细胞生长,新陈代谢,电荷变异或纯度的有害影响.
- 一个特定的组合 (0.75毫米的Tris和8毫米的银河糖) 与参考药物的糖化概况非常相匹配.
结论:
- 同时应用Tris和银河糖是一种优化BsAb糖化酶的有效策略.
- 这种方法增强了生物仿制药和参考药物之间的相似性.
- 这些发现为治疗性单克隆抗体生产的糖化调节提供了洞察力.
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