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Host Cell Protein Impurities

Meaning

Host Cell Protein (HCP) impurities are residual, unwanted proteins derived from the specific expression system, typically a bacterial, yeast, or mammalian cell line, used to manufacture recombinant biopharmaceuticals, such as certain peptide hormones or therapeutic antibodies. These process-related impurities must be rigorously monitored and removed to extremely low levels during the final purification process. Their persistent presence can potentially induce an unwanted immune response in patients, which may neutralize the therapeutic agent or cause severe allergic reactions. This is a critical quality control parameter in the highly regulated biomanufacturing industry.