Faculty of Pharmacy, Kinki University, Kowakae 3-4-1, Higashi, Osaka 577-8502, Japan.
J Chromatogr A. 2013 Sep 27;1309:76-83. doi: 10.1016/j.chroma.2013.08.021. Epub 2013 Aug 13.
Monoclonal antibody (mAb) pharmaceuticals are much more complex than small-molecule drugs. Such complex characteristics raise challenging questions for regulatory evaluation. Although heterogeneity in mAbs based on their charge variants has been mainly evaluated using gel-based isoelectric focusing (IEF) method, recent development in capillary electrophoresis and microchip electrophoresis has made it possible to assure their heterogeneities in more easy and rapid manner. In the present paper, we customized the imaged microchip isoelectric focusing (mIEF) for the analysis of mAbs, and compared the customized version with the conventional capillary isoelectric focusing (cIEF) method, and found that mIEF has much higher performance in operations, and its resolving powers are comparable with those obtained by cIEF.
单克隆抗体 (mAb) 药物比小分子药物复杂得多。这种复杂的特性给监管评估带来了具有挑战性的问题。尽管基于电荷变体的 mAbs 的异质性主要使用基于凝胶的等电聚焦 (IEF) 方法进行评估，但毛细管电泳和微芯片电泳的最新发展使得可以更轻松、更快速地保证它们的异质性。在本文中，我们为 mAb 的分析定制了成像微芯片等电聚焦 (mIEF)，并将定制版本与传统的毛细管等电聚焦 (cIEF) 方法进行了比较，发现 mIEF 在操作上具有更高的性能，其分辨率与 cIEF 获得的分辨率相当。
