Design and optimization of membrane chromatography for monoclonal antibody charge variant separation.

ABSTRACT: The manufacturing scale implementation of membrane chromatography to purify monoclonal antibodies has gradually increased with the shift in industry focus toward flexible manufacturing and disposable technologies. Membrane chromatography are used to remove process-related impurities such as host cell proteins (HCPs) and DNA, leachates, and endotoxins, with improved productivity and process flexibility. However, application of membrane chromatography to separate product-related variants such as charge variants has not gained major traction due to low-binding capacity. The work reported here demonstrates that a holistic process development strategy to optimize static binding (pH and salt concentration) and dynamic process (membrane loading, flowrate, and gradient length) parameters can allev

SUBMITTER: Nadar S 

PROVIDER: S-EPMC10078440 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature