Size-exclusion chromatography based on silica-diol for the analysis of the proinsulin fusion protein

被引:7
作者
Gusarova, V. [1 ]
Vorobjeva, T. [1 ]
Gusarov, D. [1 ]
Lasman, V. [1 ]
Bayramashvili, D. [1 ]
机构
[1] Russian Acad Sci, Shemyakin Ovchinnikov Inst, Expt Biotechnol Plant, Moscow 117997, Russia
关键词
size-exclusion chromatography; validation; qualification; proinsulin fusion protein;
D O I
10.1016/j.chroma.2007.10.090
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Size-exclusion chromatography based on silica-diol sorbent was employed to analyze the recombinant proinsulin fusion protein obtained during the process of refolding and the following ion-exchange purification. The assay was qualified as a control method estimating its accuracy, precision, linearity, limit of detection, limits of quantitation, specificity, and robustness. The results show the reliability for the intended use. (c) 2007 Elsevier B.V. All rights reserved.
引用
收藏
页码:157 / 162
页数:6
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