Analytical R&D, Pfizer BioTherapeutics R&D, Chesterfield, MO, USA.
Electrophoresis. 2010 Jan;31(3):448-58. doi: 10.1002/elps.200900371.
A CGE method for monitoring the disulfide isomer distribution characteristic of IgG2 MAbs is presented. Disulfide heterogeneity of MAbs has been studied using various chromatographic and electrophoretic methods. Although CGE operates using a different selectivity mechanism from that of sorption chromatographic techniques, similar trends are present in the data, which allow the CGE method to be used as a complementary method for studying disulfide isomer distribution. This article focuses on the optimization of a capillary-based gel electrophoresis method that can be used to support antibody development including bioprocess optimization, antibody characterization, release, and formulation stability assessment.
本文提出了一种监测 IgG2 单抗中二硫键异构分布特征的 CGE 方法。已经使用各种色谱和电泳方法研究了单抗的二硫键异质性。尽管 CGE 的操作选择性机制与吸附色谱技术不同，但数据中存在相似的趋势，这使得 CGE 方法可以作为研究二硫键异构体分布的补充方法。本文重点介绍了一种基于毛细管的凝胶电泳方法的优化，该方法可用于支持抗体开发，包括生物工艺优化、抗体表征、放行和制剂稳定性评估。
