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一种简单的快速HPLC-UV方法,用于评估Darbepoetin Alfa中的C端氨酸含量

Dmitry I Zybin¹, Anatoly A Klishin¹, Natalia V Orlova¹

¹PHARMAPARK LLC, Moscow, Russia.

Biomedical chromatography : BMC

|February 7, 2025

概括

一种新的HPLC-UV方法快速评估了 darbepoetin alfa生物类似剂中的C端Arg166含量. 这种质量控制工具有助于开发和优化重组药物生产.

科学领域:

生物制药学分析分析
蛋白质化学蛋白质化学
分析化学是一种分析化学.

背景情况:

确保结构,物理化学和功能相似性对于生物类似药物开发至关重要.
达尔贝丁阿尔法是一种治疗性蛋白质,需要严格的质量评估.

研究的目的:

开发一种简单,快速的HPLC-UV方法,用于定量C端Arg166在达伯素α中的数量.
为了提供一种工具,用于在复合达伯丁α生产过程中进行质量评估.

主要方法:

具有紫外线检测 (HPLC-UV) 的高性能液体染色学.
样品提取和染色学分析.
对C端素166 (Arg166) 含量的分析.

主要成果:

建立了一种方法来评估C端Arg166含量.
整个过程,从提取到染色学概况,大约需要5个小时.
该方法适用于从培养液中分离的达比波丁α样本.

结论:

拟议的HPLC-UV方法对达伯丁α的质量控制有效.
这种方法支持开发和优化重组达尔比丁α生产技术.
该方法有助于生物制药实验室评估产品质量.

关键词:

在C端的阿尔金因中.在HPLC中使用HPLC.达尔贝波埃丁阿尔法 (Darbepoetin alfa) 是一种

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