Host Cell Protein Analysis

Host cell proteins (HCPs) pose a potential safety risk for biologic or proteinaceous drug compounds. As therapeutically relevant biomolecules are often produced in a biological expression system, remnants from the host cell can be co-purified during the manufacturing process. These host-cell proteins (HCPs) can, even at low levels, negatively impact the stability and functionality of the product. Therefore, regulatory agencies demand identification and risk analysis of all residual host cell derived contaminations during the drug approval process. Even for approved drugs, HCPs need to be routinely monitored and exactly quantified in every production batch of a drug. To address the regulatory requirements, manufacturers need to optimize the production process to reduce the amount of host cell derived contaminations as much as possible and to establish a surveillance process to monitor the removal of HCPs during production. The most commonly used method to determine the amounts of HCPs in pharmaceutical industry currently is ELISA. However, this method often relies on polyclonal antibodies, providing limited specificity. Furthermore, setting up ELISA for new expression systems is often a bottleneck, as it depends on antibody availability.