Gantt chart of host cell protein (HCP) time planning toolThe presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. 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 is essential in determining the safety of a product. Once a biopharmaceutical is used in Phase III clinical studies, a validated, product-specific HCP assay is usually required. Use the timeline generator below to find out how long it will take for the development and validation of a custom host cell protein bioassay for your product.

Map out your assay development