HCP Residual Detection

Host cell protein (HCP) residual-detection molecules are a set and supporting reagents used to detect, quantify, and characterize residual host-cell proteins in purified products during biologic manufacturing—holding a regulatory mandatory position in the quality control and release safety-evaluation systems of recombinant proteins, antibodies, and vaccines. These molecules include: the host-cell proteins themselves (full host-cell protein components and specific sub-class proteins from CHO, HEK293, NS0, Sp2/0, E. coli expression systems, including fast-changing low-abundance HCP, high-abundance HCP, upstream-processing residues, and residual host-cell DNA); anti-HCP antibodies (anti-HCP polyclonal, anti-HCP monoclonal, antibodies against high- and low-abundance HCP, and HCP polyclonal antibodies specifically recognizing different hosts such as CHO, HEK, NS0); and supporting detection molecules and standards (recombinant HCP standards and internal controls, HRP- and AP-labeled anti-human IgG secondary antibodies, colorimetric substrates TMB and BCIP/NBT and ECL chemiluminescent substrates, ELISA kits, Western-blot transfer and staining systems, LC-MS/MS HCP identification and database analysis, and HCP residual-detection kits and immunogenicity-assessment tools). HCP residual-detection molecules play an irreplaceable key supporting role in biologic purification-process development and validation, residual-level control, immunogenicity and safety-risk assessment, and biologic quality-standard establishment and CMC compliance.