Christians Stefan, van Treel Nadine Denise, Bieniara Gabriele, Eulig-Wien Annika, Hanschmann Kay-Martin, Giess Siegfried
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.
Biologicals. 2016 Jul;44(4):234-241. doi: 10.1016/j.biologicals.2016.04.001. Epub 2016 May 4.
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.
毛细管区带电泳（CZE）提供了一种基于天然蛋白质固有电泳迁移率来分离它们的替代方法。CZE的主要优点是通过紫外检测进行定量，避免了凝胶电泳方法中染色和光密度测定的缺点。本验证研究的数据表明，CZE是测定人白蛋白和人多克隆免疫球蛋白治疗制剂中蛋白质组成的可靠方法。只要在不进行时间校正的情况下进行峰积分，CZE获得的数据就与药典方法获得的“历史”数据一致。这里的重点是建立一种快速可靠的测试方法，以替代当前基于凝胶的区带电泳技术，用于欧洲药典中人免疫球蛋白或白蛋白蛋白质组成的控制。我们认为，这里描述的更先进、更现代的CZE方法是相关专论中目前描述的程序的一个非常好的替代方法。
