Analytical R&D, Pfizer BioTherapeutics R&D, Chesterfield, MO 63017, USA.
J Sep Sci. 2010 Feb;33(2):218-27. doi: 10.1002/jssc.200900597.
Capillary gel electrophoresis (CGE) methods with UV detection were developed for reduced and non-reduced mAb analysis. These methods can be used to evaluate mAb purity, offering more reproducible quantitation compared with that of traditional SDS-PAGE methods. These CGE methods have been utilized as platform technology for bioprocess development, formulation development, mAb characterization, drug substance/drug product release testing as well as a required methodology for stability testing. We have found these CGE methods to be applicable across a platform of mAbs in preclinical and clinical development, with the majority of mAbs requiring no modification to the method conditions. This methodology has been ICH validated and transferred to several supporting organizations. The data presented herein describes the development of CGE methodology, platform application to mAb purity analysis, ICH validation, reliability metrics, and considerations on technology enhancement for improved performance and throughput.
毛细管凝胶电泳 (CGE) 方法与紫外检测被开发用于还原和非还原 mAb 分析。这些方法可用于评估 mAb 的纯度，与传统的 SDS-PAGE 方法相比，提供更可重复的定量结果。这些 CGE 方法已被用作生物工艺开发、配方开发、mAb 表征、药物物质/产品放行测试以及稳定性测试所需方法的平台技术。我们发现这些 CGE 方法适用于临床前和临床开发的 mAb 平台，其中大多数 mAb 不需要对方法条件进行修改。该方法已通过 ICH 验证，并转移到几个支持组织。本文介绍了 CGE 方法的开发、平台在 mAb 纯度分析中的应用、ICH 验证、可靠性指标，以及考虑增强技术以提高性能和通量的相关内容。
