Identification and characterization of CHO host-cell proteins in monoclonal antibody bioprocessing.

ABSTRACT: Host-cell proteins (HCPs) are the foremost class of process-related impurities to be controlled and removed in downstream processing steps in monoclonal antibody (mAb) manufacturing. However, some HCPs may evade clearance in multiple purification steps and reach the final drug product, potentially threatening drug stability and patient safety. This study extends prior work on HCP characterization and persistence in mAb process streams by using mass spectrometry (MS)-based methods to track HCPs through downstream processing steps for seven mAbs that were generated by five different cell lines. The results show considerable variability in HCP identities in the processing steps but extensive commonality in the identities and quantities of the most abundant HCPs in the harvests for different p

SUBMITTER: Oh YH 

PROVIDER: S-EPMC10842603 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature