Imaged capillary isoelectric focusing method development for charge variants of high DAR ADCs

Charge heterogeneity is a critical quality attribute for therapeutic biologics including antibody-drug conjugates (ADCs). Developing an ion exchange chromatography (IEX) or an imaged capillary isoelectric focusing (icIEF) method for ADCs with high drug-to-antibody ratio (DAR) is challenging because...

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Veröffentlicht in:	Analytica chimica acta 2024-11, Vol.1328, p.343176, Article 343176
Hauptverfasser:	Leng, Chuan, Sun, Shuwen, Lin, Wei, Pavon, Jorge Alexander, Gennaro, Lynn, Gunawan, Rico C., Bu, Xiaodong, Yang, Tong, Li, Senwu
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies, Monoclonal - analysis Antibodies, Monoclonal - chemistry Antibody-drug conjugate (ADC) Capillary Isoelectric Focusing Charge variant Drug-to-antibody ratio (DAR) Electrophoresis, Capillary - methods Imaged capillary isoelectric focusing (icIEF) Immunoconjugates - analysis Immunoconjugates - chemistry Isoelectric Focusing - methods Method development Monoclonal antibody (mAb)
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