Identification, Characterization and Removal of Host-Cell Proteins (HCP) in Chinese Hamster Ovary (CHO) Monoclonal Antibody Biomanufacturing Processes

The team will develop a consistent, comprehensive approach to identify and clear problematic HCPs in mAb biomanufacturing. Our starting point will be to determine the identities and levels of HCPs in representative mAb bioprocesses based on CHO cells.
Categories
Drug substance
Data
Project status
100% Completed

Industry Need

MAb manufacturing platform processes have evolved that are capable of achieving target levels of key impurities, including HCPs, DNA and product-related impurities such as HMW aggregates. The HCP assays used – typically ELISA methods – leave open the possibility that although overall HCP levels may meet target specifications, the residual concentrations of individual HCPs may be undesirably high.

Solution

We propose to develop a consistent, comprehensive approach to identify and clear problematic host-cell proteins (HCPs) in monoclonal antibody (mAb) biomanufacturing.

Outputs/Deliverables


  • Database of CHO HCPs, including patterns of removal in typical mAb platform process steps.
  • Knowledge base of HCP interactions with mAb products and significance for HCP tracking in existing commercial processes.
  • Resins based on peptide ligands for capturing broad spectrum of HCPs from CHO cell lines.

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