CHO Host Cell Protein ELISA Kit, 3G

Cygnus Technologies 3rd Generation CHO HCP ELISA Kit provides the specificity and sensitivity to detect CHO host cell protein (HCP) impurities with reproducibility that supports regulatory compliance. The kit has been extensively qualified with many drug substances and in-process samples. The antibody has been evaluated for reactivity to individual HCPs using conventional 2D Western Blot and Antibody Affinity Extraction (AAE). AAE demonstrated the antibody is reactive to more than 1000 individual HCPs from conditioned media and cell lysates in both currently used CHO strains. These 1000+ HCPs represent more than 98% of the total mass of protein as indicated by orthogonal to ELISA protein detection methods. This ELISA is also more robust than the earlier kits showing less sample matrix interference and improved dilution linearity. The kit contains all components to evaluate the presence of HCP impurities in 96 samples, including a set of calibrated CHO HCP standards.