A New Generation of Generic HCP AssaysThe CHO 360-HCP Assay

摘要

Host-cell protein (HCP) analysis is a big issue when it comes to early clinical testing, design of downstream processes, and quality control of biopharmaceuticals. The decision to use an off-the-shelf generic HCP assay or spend a considerable amount of money for development of a specific HCP assay is often not an easy one. In theory, generic HCP assays should be suitable for all HCP determinations of a specific cell line — independent of cell line modifications, fermentation conditions, and the design of the purification process. But in most cases, generic HCP assays do not show the desired specificity and sensitivity.