Front Cover: Interlaboratory method validation of icIEF methodology for analysis of monoclonal antibodies. Issue 16 (21st August 2018)

• Record Type: Journal Article
• Authors: Wu, Gang; Yu, Chuanfei; Wang, Wenbo; Wang, Lan
• Is Part Of: Electrophoresis. Volume 39:Issue 16(2018)
• Page Start: NA
• Page End: NA
• Publication Date: 2018-08-21
• Subjects: Electrophoresis -- Periodicals; Electrophoresis -- Periodicals; 541.372
• DOI: 10.1002/elps.201870131
• Languages: English
• ISSNs: 0173-0835

Abstract

Abstract : DOI:10.1002/elps.201800118 The cover picture shows the method validation of icIEF for analyzing monoclonal antibodies by depicting antibodies as arrows hitting targets, which is meant to signify the method's specificity, precision, accuracy and robustness. The concentric rings of the targets represent a pI gradient which symbolizes the antibody reaching an apparent pI during capillary isoelectric focusing. The present study validates icIEF technology by 10 laboratories across 8 independent companies using a therapeutic mAb. The parameters of this method validation strictly follow the guideline of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.