Practical method development for the separation of monoclonal antibodies and antibody-drug-conjugate species in hydrophobic interaction chromatography, part 1: optimization of the mobile phase.

Journal of Pharmaceutical and Biomedical Analysis(2016)

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摘要
•Numerous variables impacting selectivity and retention in HIC were studied.•Generic experimental design was suggested for method development.•Accurate retention time prediction was feasible.•Applications were developed for mAbs and ADC DARs.
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关键词
Hydrophobic interaction chromatography,Monoclonal antibody,Antibody-drug-conjugate,Method development,Brentuximab-vedotin
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