Host Cell Proteins During Biomanufacturing

초록

Host cell protein (HCP) impurities, endogenous proteins expressed from host cells, can challenge biopharmaceutical manufacturing. Certain HCPs can persist even after downstream purification, leading to adverse impacts on drug stability and potentially, patient safety. Thus, the quantification and control of HCPs is critical. Although many improvements have been made in HCP quantification and control methods, HCP-associated risks cannot be completely eliminated. A better biophysical understanding of Chinese hamster ovary (CHO) HCPs and advancement of monitoring assays will lead to better controlled biopharmaceutical manufacturing. This chapter will discuss (i) current HCP removal processes for various product types, (ii) the impact of residual HCPs on drug efficacy and safety, (iii) HCP quantification and monitoring methods such as proteomics approaches and enzyme-linked immunosorbent assays (ELISA) using anti-HCP antiserum, (iv) HCP control approaches in both upstream and downstream processes, and (v) future directions for effective HCP risk management strategies. © 2020 Wiley-VCH Verlag GmbH & Co.

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