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.
We propose to develop a consistent, comprehensive approach to identify and clear problematic host-cell proteins (HCPs) in monoclonal antibody (mAb) biomanufacturing.
Database will include characterization of HCP interactions with mAb products and typical resins.
Improved PepMix(es) for capturing a broad spectrum of HCPs from CHO cell lines, including the clearance of problematic HCPs.
Database of CHO host cell proteins (HCPs) and their biophysical properties, particularly those that are difficult to remove during manufacturing.
Oh, Y. H., Becker, M. L., Mendola, K. M., Choe, L. H., Min, L., Lee, K. H., Yigzaw, Y., Seay, A., Bill, J., Li, X., Roush, D. J., Cramer, S. M., Menegatti, S., & Lenhoff, A. M. (2024). Factors affecting product association as a mechanism of host-cell protein persistence in bioprocessing. Biotechnology and Bioengineering, 121(4), 1284–1297. https://doi.org/10.1002/bit.28658
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University of Delaware
Genentech, Inc.
Merck Sharp & Dohme LLC
North Carolina State University
Rensselaer Polytechnic Institute
Repligen Corporation
