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CHO HCP ELISA kit, 3G

This CHO HCP 3rd Generation ELISA kit uses a new and even more broadly reactive antibody than our earlier kits. The kit incorporates a number of other improvements in the detection of CHO HCPs. This new ELISA is more sensitive than the previous kits, able to detect HCPs in the range of 100 parts per billion for a variety of antibodies and other therapeutic proteins expressed in CHO. It has been extensively qualified with a large number of drug substances and inprocess samples. This data indicates the kit is truly a generic method that can likely be validated as not only a process development tool, but in most cases as a lot release test, eliminating the need to develop a custom or process specific assay. The antibody has been evaluated for reactivity to individual HCPs using the conventional 2D Western Blot as well as a method we have shown to be superior to 2D WB, which we call 2D HPLCELISA. This 2D HPLCELISA method demonstrated the antibody is reactive to more than 750 individual HCPs from conditioned media and cell lysates in both a CHOS strain as well as a K1 strain. These 750+ HCPs represent more than 98% of the total mass of protein as indicated by protein detection methods orthogonal to ELISA. As such, this antibody may overcome concerns about missing any significant individual HCPs.