کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1220274 1494622 2015 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Ion-exchange chromatography for the characterization of biopharmaceuticals
ترجمه فارسی عنوان
کروماتوگرافی مبادله ایون برای مشخص کردن مواد بیولوژیک
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی


• The theoretical aspects of IEX are overviewed.
• The analytical conditions for performing modern IEX are reviewed.
• The recent advances in IEX are discussed.
• Several examples of IEX for biopharmaceutical applications are provided.

Ion-exchange chromatography (IEX) is a historical technique widely used for the detailed characterization of therapeutic proteins and can be considered as a reference and powerful technique for the qualitative and quantitative evaluation of charge heterogeneity. The goal of this review is to provide an overview of theoretical and practical aspects of modern IEX applied for the characterization of therapeutic proteins including monoclonal antibodies (Mabs) and antibody drug conjugates (ADCs). The section on method development describes how to select a suitable stationary phase chemistry and dimensions, the mobile phase conditions (pH, nature and concentration of salt), as well as the temperature and flow rate, considering proteins isoelectric point (pI). In addition, both salt-gradient and pH-gradient approaches were critically reviewed and benefits as well as limitations of these two strategies were provided. Finally, several applications, mostly from pharmaceutical industries, illustrate the potential of IEX for the characterization of charge variants of various types of biopharmaceutical products.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 113, 10 September 2015, Pages 43–55
نویسندگان
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