AMS Bio has launched a range of ELISA host cell protein (HCP) detection kits that allow users to detect the presence of host cell protein impurities in their therapeutic at any phase of their product development
Host cells used as expression systems in biopharmaceutical products contain hundreds to thousands of HCPs. It is crucial to sufficiently remove HCPs from a biologic early, as high concentrations can affect the safety and efficacy of the drug. The FDA has regulated that HCPs should be reduced to low levels.
The new HCP detection kits are based on a sandwich ELISA test in a convenient 96-well plate format. The assay uses a standard for quantification which enables highly sensitive and accurate determination of HCP concentrations. These kits can be used during the protein purification process in order to monitor and optimise that step of the bioproduction workflow.
Based upon quick and widely familiar ELISA technology, specific HCP detection kits are available for popular expression systems including CHO, E. coli, Pichia, HEK293, and Protein A. Each kit allows quantification of up to 24 samples. Compared to alternative HCP detection kits, those from AMS Bio offer 5-10x more sensitivity, greater antibody coverage and lower lot-to-lot variations resulting in a more consistent reliable antibody supply and a reduction in the cost of the biomanufacturing process.
