A new range of detection kits, based on a sandwich ELISA test, could enable detection of host cell protein (HCP) impurities which could affect therapeutic safety and efficacy. The kits, from AMSBIO (UK), enable the sensitive and accurate determination of HCP concentrations.
FDA has regulated that HCPs should be reduced to low levels. However, host cells used as expression systems in biopharmaceutical products could contain hundreds to thousands of HCPs. Compared to alternative HCP detection kits, AMSBIO 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.