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Front Cover: Interlaboratory method validation of icIEF methodology for analysis of monoclonal antibodies
Author(s) -
Wu Gang,
Yu Chuanfei,
Wang Wenbo,
Wang Lan
Publication year - 2018
Publication title -
electrophoresis
Language(s) - English
Resource type - Reports
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.201870131
Subject(s) - isoelectric focusing , monoclonal antibody , harmonization , robustness (evolution) , front cover , chromatography , computer science , cover (algebra) , chemistry , antibody , biology , engineering , immunology , biochemistry , physics , mechanical engineering , gene , acoustics , enzyme
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.