The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. With over 30 years of combined experience, our team of host cell protein experts assists clients in the development of a downstream process with the use of effective assays to determine both the concentration of the product and the quantity and concentration of host cell proteins present. The assays used accurately monitor changes in the product concentration and the removal of host cell proteins after purification.
Charles River's HCP-GAPex℠ service is the first holistic approach to host cell protein assay development. Combining tools from proteomics, bioinformatics, protein synthesis and immunology, the service minimizes black box elements, provides targeted enhancement of coverage and maximizes the performance of HCP assays.