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阿弗利伯塞特生物类似ABP 938与阿弗利伯塞特参考产品的分析和功能相似性

Neungseon Seo¹, Xiaoyan Guan², Tian Wang²

¹Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA. neungseon.seo@amgen.com.

Ophthalmology and therapy

|March 20, 2024

概括

作为阿弗利塞普特的生物类似物候选物ABP 938,与参考产品具有结构和功能上的相似性. 这种分析性可比性支持其用于治疗血管性眼部疾病的发展.

科学领域:

生物制药科学生物制药科学
眼科医生眼科眼科
分析化学分析化学

背景情况:

ABP 938是aflibercept的生物类似候选者,aflibercept是治疗血管性眼睛疾病的生物疗法.
阿弗利塞普特参考产品 (RP) 广泛用于治疗各种眼睛疾病.

研究的目的:

进行ABP 938和aflibercept RP.P.的比较分析评估.
评估ABP 938的结构和功能属性与美国和欧盟的aflibercept RP相比.

主要方法:

利用最先进的分析技术进行全面的表征.
评估了初级和更高阶结构,生物物理性质和生物活动.
分析的与产品相关的物质和杂质.

主要成果:

ABP 938表现出与aflibercept RP相同的氨基酸序列和可比的二级/三级结构和生物活性.
观察到微小的生化差异,预计不会影响临床性能.
美国和欧盟来源的Aflibercept RP被发现在分析上是相似的.

结论:

在结构和功能上,ABP 938与aflibercept RP相似.
美国和欧盟之间的分析相似性使得RP能够建立科学桥梁.
一个单一来源的参考产品可以用于非临床和临床研究.

关键词:

ABP 93838 ABP 93838 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 ABP 938 一个自由的概念.分析上的相似性.生物类似药物制品生物类似药物制品眼部疾病眼部疾病结构和功能上的相似性.在VEGF中,VEGF是VEGF.

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