Modeling the behavior of monoclonal antibodies on hydrophobic interaction chromatography resins  

作　　者：Douglas Nolan Thomas RChin Mick Eamsureya Sheldon Oppenheim Olga Paley Christina Alves George Parks 

机构地区：[1]Takeda Pharmaceuticals America Inc,Lexington,MA 02421,USA [2]Eurofins Lancaster Laboratories Professional Scientific Services,LLC,Lancaster,PA 17601,USA

出　　处：《Bioresources and Bioprocessing》2024年第1期332-355,共24页生物资源与生物加工(英文)

摘　　要：Monoclonal antibodies(mAbs)require a high level of purity for regulatory approval and safe administration.High-molecular weight(HMW)species are a common impurity associated with mAb therapies.Hydrophobic interaction chromatography(HIC)resins are often used to remove these HMW impurities.Determination of a suitable HIC resin can be a time and resource-intensive process.In this study,we modeled the chromatographic behavior of seven mAbs across 13 HIC resins using measurements of surface hydrophobicity,surface charge,and thermal stability for mAbs,and hydrophobicity and zeta-potential for HIC resins with high fit quality(adjusted R2>0.80).We identified zeta-potential as a novel key modeling parameter.When using these models to select a HIC resin for HMW clearance of a test mAb,we were able to achieve 60%HMW clearance and 89%recovery.These models can be used to expedite the downstream process development for mAbs in an industry setting.

关 键 词：Bioprocess engineering CHROMATOGRAPHY Statistical analysis BIOENGINEERING 

分 类 号：S51[农业科学—作物学]