Quantitative analysis of monoclonal antibodies by cation-exchange chromatofocusing

被引：33
|
作者：
Rozhkova, Anna [1 ]
机构：
[1] Solvias AG, Analyt Klybeck, CH-4002 Basel, Switzerland
来源：
JOURNAL OF CHROMATOGRAPHY A | 2009年 / 1216卷 / 32期
关键词：
Monoclonal antibody; Cation-exchange chromatofocusing; pH gradient; Acidic species quantitation; Isoform content determination; Lot release analysis; SIMPLE BUFFER MIXTURES; PERFORMANCE LIQUID-CHROMATOGRAPHY; PH GRADIENTS; MULTIDIMENSIONAL CHROMATOGRAPHY; SEPARATING PROTEINS; COLUMNS; HPLC; HETEROGENEITY; SUITABILITY; TRANSITIONS;
D O I：
10.1016/j.chroma.2009.06.045
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
A robust cation-exchange chromatofocusing method was developed for the routine analysis of a recombinant humanized monoclonal IgG antibody. We compare the chromatofocusing method to the conventional cation-exchange chromatography (CEX) employing a salt gradient and show clear advantages of chromatofocusing over CEX We demonstrate the suitability of the present chromatofocusing method for its intended purpose by testing the validation characteristics. To our knowledge, this is the first chromatofocusing method developed for the routine analysis of monoclonal antibody charge species. (C) 2009 Elsevier B.V. All rights reserved.
引用
收藏
页码：5989 / 5994
页数：6
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