Host Cell Protein Assays

Charles River is able to offer clients generic host cell protein (HCP) assays as well as assist with the development of customized assays for the detection of host cell proteins. The type of assay required to determine the HCP is dependent upon the phase of product development. In the early process development phase, as well as in the early clinical phases, generic assays are normally acceptable. However, once the biopharmaceutical is used in Phase III clinical studies, a validated, product-specific HCP assay is usually required. Charles River can help you with assay development and validation regardless of whether you are in preclinical development or embarking on Phase III studies.