Host cell protein (HCP) in biomanufacturing
Host cell proteins (HCPs) are impurities in therapeutic proteins that can pose risks to patients, and mass spectrometry is becoming a crucial tool for detecting and identifying specific HCPs. Regulatory agencies now promote a knowledge-driven, risk-based approach to HCP analysis, relying on mass spectrometry support data in biologics filings.
Mass spectrometry is increasingly important in biomanufacturing for detecting host cell proteins (HCPs), impurities in therapeutic proteins produced in recombinant hosts like E. coli and Chinese hamster ovary cells. HCPs can cause immunogenicity, unfavorable reactions, and reduced efficacy. Regulatory authorities require a control strategy for impurities, and sponsors must demonstrate HCPs have been measured and reduced to safe levels. Conventionally, HCP monitoring used Enzyme-Linked Immunosorbent Assay (ELISA), but this method cannot identify individual HCPs. Mass spectrometry offers unparalleled specificity, allowing users to identify individual components even at trace levels. Regulators now rely on mass spectrometry support data in biologics filings, and new guidance has been released to define mass spectrometry for improved process understanding and HCP risk assessment.
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