Platform CHO HCP ELISA with Superior Performance Characteristics
Our CHO HCP ELISA method can be used to support robust monitoring of HCP clearance through the purification process and quantify CHO host cell proteins (HCP) in purified bulk drug substance samples representing both monoclonal antibodies (mAb) and non-mAb products purified via downstream processes that may or may not include an affinity chromatography step.
Demonstrating process clearance of HCPs is oftentimes challenging for recombinant non-mAb products owing to issues of dilutional non-linearity limitations encountered with HCP ELISA methods. KBI’s unique strategy for pAb generation and detection reagent optimization can alleviate these technical challenges.