Host cell protein (HCP) levels in biologics are on the critical path for assessing product quality, and they pose a serious risk to drug safety. The challenge is to accurately quantify a complex mixture of HCP impurities, which vary in properties and abundance depending on cell line, media, and process parameters. HCP immunoassay analysis is based on polyclonal antibodies raised against HCPs from nontransfected cell lines.
Automated immunoassays with high-throughput (Gyrolab xP workstation, left) or single-CD configuration (Gyrolab xPlore, right)
How well a particular HCP assay recognizes all proteins depends on how well the antibodies match the HCP composition, their abundance, and their affinities. To cover the diversity of HCP mixtures from different bioprocesses, Gyros has developed a panel of five Gyrolab CHO-HCP kits to increase the possibility of finding the assay that best matches a specific CHO-K1 process. A scouting kit simplifies selection of the optimal generic kit with broader dynamic ranges, high sensitivity, and time to results in about an hour.