Charge variants in IgG1
作者： Leslie A. Khawli , Sirj Goswami , Ryan Hutchinson , Zephania W. Kwong , Jihong Yang
关键词: Antibody 、 In vivo 、 In vitro 、 Chromatography 、 Biochemistry 、 Monoclonal antibody 、 Recombinant DNA 、 Pharmacokinetics 、 Displacement chromatography 、 Biological activity 、 Chemistry
摘要: Antibody charge variants have gained considerable attention in the biotechnology industry due to their potential influence on stability and biological activity. Subtle differences relative proportions of are often observed during routine biomanufacture or process changes pose a challenge demonstrating product comparability. To gain further insights into impact activity pharmacokinetics (PK) monoclonal antibody (mAb) heterogeneity, we isolated major forms recombinant humanized IgG1 compared vitro properties vivo PK. The mAb starting material had pI range 8.7-9.1 was composed about 20% acidic variants, 12% basic 68% main peak. Cation exchange displacement chromatography used isolate acidic, basic, peak fractions for animal studies. Detailed analyses were performed identify specific chemical modification contributing differe...
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