Biologics, especially protein drugs, are often produced in cultured cells. Those cultured cells, called host cells, synthesize the target proteins along with the proteins coded by the cell genome for the cells’ own survival, function, and reproduction. Purifying the target protein from the other host cell proteins (HCPs) is the main task for downstream processing of biologics manufacturing.
HCP removal is crucial, as HCPs are often immunogenic and can affect the potency and stability of biologics. Therefore, detection and quantification of residual HCPs are categorized as obligatory critical quality attributes in the biologics manufacturing process, and HCPs are strictly monitored throughout production to ensure safety and potency of the products.
