Evaluation of capillary zone electrophoresis for the determination of protein composition in therapeutic immunoglobulins and human albumins

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• 作者：Stefan Christians^&dagger ; ; Nadine Denise van Treel ; ^{nadine.vantreel@pei.de" class="auth_mail" title="E-mail the corresponding author} ; Gabriele Bieniara ^{gabriele.bieniara@pei.de" class="auth_mail" title="E-mail the corresponding author} ; Annika Eulig-Wien ^{annika.eulig-wien@pei.de" class="auth_mail" title="E-mail the corresponding author} ; Kay-Martin Hanschmann ^{kay-martin.hanschmann@pei.de" class="auth_mail" title="E-mail the corresponding author} ; Siegfried Giess ^{siegfried.giess@pei.de" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Capillary zone electrophoresis ; Protein composition ; Immunoglobulins ; Albumin ; Human serum ; European pharmacopoeia
• 刊名：Biologicals
• 出版年：2016
• 出版时间：July 2016
• 年：2016
• 卷：44
• 期：4
• 页码：234-241
• 全文大小：726 K

文摘

Capillary zone electrophoresis (CZE) provides an alternative means of separating native proteins on the basis of their inherent electrophoretic mobilities. The major advantage of CZE is the quantification by UV detection, circumventing the drawbacks of staining and densitometry in the case of gel electrophoresis methods. The data of this validation study showed that CZE is a reliable assay for the determination of protein composition in therapeutic preparations of human albumin and human polyclonal immunoglobulins. Data obtained by CZE are in line with “historical” data obtained by the compendial method, provided that peak integration is performed without time correction. The focus here was to establish a rapid and reliable test to substitute the current gel based zone electrophoresis techniques for the control of protein composition of human immunoglobulins or albumins in the European Pharmacopoeia. We believe that the more advanced and modern CZE method described here is a very good alternative to the procedures currently described in the relevant monographs.