从生物基因组学和原始人胰岛素阿斯帕特的复合胰岛素阿斯帕特的体内生物特征鉴定
Akshay G Mishra1, Rutuja B Deshmane2, Damodar K Thappa2
1BioGenomics Ltd., Thane, Maharashtra, 400610, India. akshay.mishra@biogenomics.co.in.
概括
通过全面的体外生物试验,BioGenomics重组胰岛素阿斯巴特 (BGL-ASP) 通过全面的体外生物试验证明了与NovoRapid®的高度结合性和功能相似性. 这些发现支持BGL-ASP.
科学领域:
- 生物制药特征的表征
- 再组合蛋白质分析
- 在体外生物测试.
背景情况:
- 生物测试对于确定化合物的药理活性和毒性至关重要.
- 生物测试确保了重组生物制剂的质量,安全性和有效性,证实了生物相似性.
- 这项研究使用体外生物试验确定了生物类似物及其创新者之间的分析相似性.
研究的目的:
- 为了比较地描述BioGenomics复合胰岛素阿斯巴特 (BGL-ASP) 在体外.
- 评估BGL-ASP与其原始物NovoRapid®的生物活性.
- 用相关的生物测定来证明BGL-ASP的分析相似性.
主要方法:
- 在体外测试包括受体结合 (表面等离子体共振),受体自酸化,葡萄糖吸收,脂质生成和线粒生成潜力.
- BGL-ASP和NovoRapid® (参考药物) 的生物特征.
- 在子体内生物识别试验,以评估血糖降低.
主要成果:
- BGL-ASP表现出与NovoRapid®非常相似的结合亲和力.
- 胰岛素受体自酸化,葡萄糖吸收和脂质生成试验显示BGL-ASP和NovoRapid®之间存在很高的相似性.
- 线粒体发生测定和体内生物识别测试证实了BGL-ASP与NovoRapid®的相似性.
结论:
- 在体外生物测试表明,BGL-ASP与NovoRapid®具有很高的结合性和功能相似性.
- 综合性表征支持了BGL-ASP.的分析相似性.
- 这些发现对于确定生物相似性至关重要.
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