Separation of recombinant erythropoietin and human serum albumin without the use of sophisticated equipment

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS

ACS Applied Bio Materials Pub Date : 2024-09-13 DOI:10.1016/j.ab.2024.115673

Dmitry I. Zybin , Anatoly A. Klishin , Natalia V. Orlova , Dmitry А. Zyryanov , Anna I. Prostyakova , Dmitry V. Kapustin

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Abstract

A number of drugs based on recombinant erythropoietin contain human serum albumin as an auxiliary component. The presence of this protein hinders the proper control of the drug quality in accordance with the requirements of regulating agencies. We propose the novel method for separation of recombinant erythropoietin (epoetin beta) and human serum albumin. It is based on the subsequent use of hydrophobic sorbent and anion exchange resin placed in gravity flow columns (without the use of spin-columns). The proposed approach makes it possible to concentrate and purify the preparations containing the epoetin beta both at high and at minimal concentrations (the ratio of the amount of albumin and erythropoietin in the used preparations can reach 125:1). The average yield of epoetin beta after the use of hydrophobic sorbent and anion exchange resin was 75 % and 97 %, respectively. It was shown that the determined conditions of sample preparation had no affect on the content of the epoetin beta in the product.

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无需复杂设备即可分离重组促红细胞生成素和人血清白蛋白

一些以重组促红细胞生成素为基础的药物含有人血清白蛋白作为辅助成分。这种蛋白质的存在妨碍了按照监管机构的要求对药物质量进行适当控制。我们提出了一种分离重组促红细胞生成素（epoetin beta）和人血清白蛋白的新方法。该方法是在重力流柱（不使用旋流柱）中使用疏水吸附剂和阴离子交换树脂。这种方法可以浓缩和纯化含有高浓度和低浓度环氧乙烷的制剂（所用制剂中白蛋白和促红细胞生成素的比例可达 125:1）。在使用疏水性吸附剂和阴离子交换树脂后，epoetin beta 的平均产量分别为 75% 和 97%。结果表明，所确定的样品制备条件对产品中 beta 环氧乙烷的含量没有影响。

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来源期刊

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464