对物理化学和结构特性进行比较的研究表明,BGL-ASP与参考胰岛素阿斯巴尔特之间存在很高的生物相似性
Nikhil S Ghade1, Damodar K Thappa2, Jeseena Lona2
1BioGenomics Limited, Thane, Maharashtra, 400610, India. nikhil.ghade@biogenomics.co.in.
Scientific reports
|February 20, 2024
概括
生物类似胰岛素阿斯巴特 (BGL-ASP) 在结构,纯度和功能方面与参考产品具有很高的相似性. 临床试验证实了其可比的安全性和有效性,为糖尿病治疗提供了经济的替代方案.
科学领域:
- 生物化学 生物化学
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
背景情况:
- 生物类似胰岛素类似物正在扩大糖尿病患者的全球获取.
- 确定生物相似性对于监管批准和市场整合至关重要.
- BGL-ASP是一种由BioGenomics Limited开发的生物类似胰岛素阿斯巴特.
研究的目的:
- 建立BGL-ASP与参考胰岛素aspart.com生物相似性的科学基础.
- 评估BGL-ASP的关键质量属性 (CQAs),安全性,疗效和免疫性.
- 为了证明BGL-ASP作为糖尿病治疗的可比且经济的替代方案.
主要方法:
- 使用直角分析工具对CQA进行表征,重点关注结构,纯度和功能.
- 高性能液体色谱 (HPLC) 用于测试和杂质分析.
- 根据ICH和EMA指导方针进行的临床试验,以评估安全性,疗效和免疫性.
主要成果:
- 与参考产品相比,BGL-ASP在初级,二级,三级和四级蛋白质结构上具有很高的相似性.
- 在HPLC分析中,检测含量和产品相关杂质的含量相似.
- 临床试验证实了可比的安全性,疗效和免疫性,符合监管标准.
结论:
- 在结构,物理化学和生物特性方面,BGL-ASP与参考胰岛素aspart非常相似.
- 这项研究证实了BGL-ASP在治疗糖尿病的安全性和有效性.
- BGL-ASP为糖尿病患者提供了潜在的经济替代药物治疗.
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