During biologic manufacturing, it’s common to use host cells to express a target biological molecule as a final drug product, or a part of the final drug product. The host cell continues to produce its own biological molecules together with the drug product. These host cell-derived biological molecules are regarded as impurities and are subject to target substances to be removed during downstream purification. One of the main impurities are host cell-derived proteins, known as Host Cell Proteins (HCPs). The level of host cell proteins in biologics must be monitored carefully during development to optimize the downstream purification, as well as at final production to ensure the quality, efficacy and safety of the biological drugs.
The most widely used and accepted method to monitor host cell protein levels in biologics is an immunological assay, Enzyme-Linked Immunosorbent Assay, also known as ELISA. However, this coverage assay comes with some known challenges. Learn more about an enhanced anti-host cell protein antibody coverage analysis method solution.