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埃坦塞普特的正交生物相似性测试:一种绿色和白色的分析方法

Hadeer A Elkholy¹, Mamdouh R Rezk², Samah S Abbas²

¹Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini Street, Cairo, 11562, Egypt; Egyptian Drug Authority, Egypt.

|October 1, 2025

概括

生物相似的乙坦塞普特与其参考产品的结构和功能相等性得到证明. 这项研究还评估了分析方案.

科学领域:

分析化学分析化学
生物制药科学生物制药科学
绿色化学绿色化学

背景情况:

生物类药物为慢性疾病治疗提供了具有成本效益的替代品,需要严格的分析表征以获得等价性.
生物制品是复杂的分子,需要全面评估,以确保与参考产品的生物相似性和可互换性.
埃坦尼塞特生物类似药的开发需要与其创新产品进行详细的比较.

研究的目的:

为了评估使用头对头直角协议的etanercept的分析生物相似性.
评估分析协议的环境可持续性和白度特征.
确保生物相似性评估符合监管和环境标准.

主要方法:

使用了包括基映射-RP-HPLC,SEC-HPLC,DLS,SDS-PAGE,RP-HPLC,UV光谱和ELISA在内的正对角分析方法.
在etanercept生物类似药和创新产品之间进行了关键质量属性 (CQAs) 的比较.
使用绿色证书修改的生态规模,GAPI和AGREE指标,以及红色,绿色和蓝色的12模式分析,评估了环境可持续性.

主要成果:

埃坦塞普特生物类似剂在峰值区域,保留时间,分子量和结合亲和度方面表现出与创新产品相似的特征.
分析方案证明了生物类似药和参考乙坦塞普特之间的结构和功能等价性.
环境评估表明,该协议的可持续性和白色特性符合国际标准.

结论:

开发的直角分析协议有效地证实了etanercept的生物相似性.
综合绿色和白色分析化学评估支持该协议的环境可持续性.
这种全面的方法确保生物相似性评估符合质量和生态要求.

关键词:

对生物相似性进行评估.聚变蛋白是指聚变蛋白中的一种蛋白.绿色化学是一种绿色化学.正角协议是指一个正角协议.类映射映射类映射白色的分析指数.

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