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Protein A chromatography is commonly used as the initial step for purifying monoclonal antibody biotherapeutics expressed in mammalian tissue culture cells. The purpose of this step, as well as later chromatography steps, is, in part, to remove host cell proteins (HCPs) and other related impurities. Understanding the retention mechanism for the subset of HCPs retained during this step is of great...
Residual host cell proteins (HCPs) in biotherapeutics can present potential safety risks to patients or compromise product stability. As such, their levels are typically monitored using a multicomponent HCP enzyme-linked immunosorbent assay (ELISA) to ensure adequate removal. However, it is not possible to guarantee ELISA coverage of every possible HCP impurity, and the specific HCPs remaining following...
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