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 c...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.展开更多
文摘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.
