生物类似物BAT1806/BIIB800的比较结构与活动关系的表征,以 Tocilizumab 为参考
Yujie Liu1, Jianhua Xie1, Zhuxiang Li1
1Bio-Thera Solutions, Ltd, Guangzhou, China.
概括
根据BAT1806/BIIB800 (TofidenceTM/tocilizumab-bavi),这是托西利祖马布的生物类似剂,与参考托西利祖马布 (TCZ) 相比,质量属性的微小差异没有显示任何功能影响. 这支持其与TCZ的相似性.
科学领域:
- 生物制药特征的表征
- 对生物相似性进行评估.
- 结构与活动之间的关系.
背景情况:
- BAT1806/BIIB800 (TofidenceTM/tocilizumab-bavi) 是一种与托西利祖马布 (TCZ) 生物相似的药物.
- 最初的评估显示了高度的分析和功能相似性.
- 细微的属性差异需要进一步调查.
研究的目的:
- 评估BAT1806/BIIB800和TCZ之间的质量属性差异的潜在影响.
- 描述结构-活性关系以确认生物相似性.
主要方法:
- 进行的结构-活动关系 (SAR) 研究.
- 研究了糖化,糖化,电荷变异,疏水性,氧化和脱化.
- 在多个场合使用了各种各样的调查技术.
主要成果:
- 在BAT1806/BIIB800中含有更高的平均糖化蛋白质含量并没有影响生物活性.
- 其他属性的微小差异没有影响介素-6受体结合或效应器功能.
- 强制降解研究显示了可比的氧化和脱化趋势.
结论:
- 在BAT1806/BIIB800和TCZ之间没有发现影响功能的质量属性的相关差异.
- 在生物类似药和参考药之间观察到的差异没有功能上的影响.
- 结果支持得出的结论是,BAT1806/BIIB800与TCZ非常相似.
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