کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1166401 1491119 2012 16 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
High resolution separation methods for the determination of intact human erythropoiesis stimulating agents. A review
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
High resolution separation methods for the determination of intact human erythropoiesis stimulating agents. A review
چکیده انگلیسی

Human erythropoietin (hEPO), a hormone involved in the formation of red blood cells, is a 30 kDa glycoprotein with a high carbohydrate content. The production of recombinant hEPO has made possible its widespread therapeutic use and its banned use in competition sports. Methods to analyze EPO and other erythropoiesis stimulating agents (ESAs) are necessary for the characterization and quality control of these biopharmaceuticals and also for doping control. In this paper, high resolution separation methods, namely high performance liquid chromatography (HPLC) and capillary electrophoresis (CE), with special attention to CE-coupled mass spectrometry, are reviewed. The usefulness of these techniques when applied in different modes to separate the glycoprotein isoforms, aggregates or excipients are detailed. In addition, sample preparation methods that have been applied to ESA samples for subsequent determination by HPLC or CE, as well as the potential compatibility of other preparation methods, are discussed. Applications of the HPLC and CE methods regarding regulatory considerations for biopharmaceuticals analysis, with emphasis on biosimilars, and doping control are also included. Finally, limitations of the present methods and their possible solutions are considered.

.Figure optionsDownload as PowerPoint slideHighlights
► Methods to analyze EPO and other erythropoiesis stimulating agents (ESAs) are needed.
► Characterization of biopharmaceuticals and doping control are required.
► HPLC and CE enable to perform analysis of EPO and other ESAs.
► These techniques allow separating glycoprotein isoforms, aggregates or excipients.
► Sample preparation and detection methods could help to overcome present limitations.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Analytica Chimica Acta - Volume 713, 3 February 2012, Pages 7–22
نویسندگان
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