The host cells used for recombinant expression contain hundreds to thousands of host cell proteins (HCPs) that can contaminate biopharmaceutical products. Failure to sufficiently reduce impurities early in drug development can reduce drug efficacy or lead to adverse patient reactions. Regulatory guidelines require reduction of HCPs to the lowest levels possible.
Use our generic kits for host cell protein analysis:
ELISA kits for the detection of <1 ppm host cell proteins from a variety of cell lines commonly used in the production of complex therapeutic proteins.
ELISA kits for the detection of <1 ppm of host cell proteins from P. pastoris and S. cerevisiae.
Generic and custom kits for the detection of contaminating proteins from a range of host species.
ELISA kits for the detection of <1 ppm host cell proteins from E. coli, L. lactis, P. fluorescens, and S. aureus.
HCPs constitute a major group of process-related impurities of biological drugs produced using cell culture technology. HCPs co-purify with biological drug substances (DS) as a process-related impurity and pose potential risks for both patients and drug manufacturers. When present in the administered product even at low levels, HCPs can induce an undesired immune response, interfere with drug efficacy and impact drug stability. Thus, HCPs remain a critical quality attribute (CQA) for bioprocess development and must be adequately removed during the downstream purification process.
A robust and broadly reactive HCP ELISA is a critical tool for monitoring purification process consistency as well as final drug substance purity. Cygnus HCP ELISA assays provide the specificity and sensitivity to detect impurities with reproducibility that supports regulatory compliance. Its reputation for quality is recognized by the industry and global regulatory agencies with Cygnus HCP assays used as reference methods for the industry or to support manufacturing and quality control (QC) of commercialized biologics.
Various cell lines are used for manufacturing of therapeutic monoclonal antibodies and recombinant proteins, next-generation recombinant vaccines and viral vectors for cell and gene therapies. Cygnus offers HCP ELISAs for virtually all expression platforms. BHK HCP ELISA, HEK293 HCP ELISA, PER.C6® HCP ELISA, Vero Cell HCP ELISA, HeLa HCP ELISA, Sf9 HCP ELISA and other cell line HCP ELISAs are used for process development and QC during recombinant vaccine and viral vector manufacturing. CHO HCP ELISA 3G, CAP® HCP ELISA, PER.C6® HCP ELISA, NS/0 HCP ELISA, SP2/0 HCP ELISA, E. coli HCP ELISA, P. pastoris HCP ELISA, S. cerevisiae HCP ELISA, and other cell line HCP ELISAs are used during process development and final product QC during therapeutic monoclonal antibodies and recombinant protein manufacturing. Contact our technical experts at [email protected] if you do not see your production cell line in our HCP ELISA product offering.