Host cell proteins (HCPs) are one of the main impurities in bio-therapeutics coming from the host expression system. Although HCPs are at low levels, they can trigger immunogenic reactions in the human system when administered along with bio-therapeutics. The similarity of physicochemical properties of HCPs and therapeutic proteins result in co-purification. Detection and elimination of these HCPs during bio-therapeutics purification are required.
In addition, regulatory agencies require pharmaceutical companies to monitor HCPs levels during the drug development stages and decrease them to an acceptable level in the final product.
AMSbiopharma has developed a mass spectrometry strategy for the detection and quantitation of the HCPs from your biopharmaceutical. This novel strategy is based in four different stages: