A critical task in biologics manufacturing is the control of process-related impurities such as host cell proteins (HCPs), which co-purify with the drug substance and are known for adverse effects. Although immunoassays have been the method of choice for HCP determination, there are some inevitable risk factors associated with this approach.

In this presentation, we highlight critical parameter and quality attributes along the entire HCP assay development process, including considerations for the choice of a suitable antigen; optimization of the immunization process; qualification of antigen and antisera as reagents for a GMP compliant assay development; targeted enhancement of coverage; and orthogonal tools for direct analysis of HCP impurities.


  • Olaf Stamm, PhD, MDRA, Senior Specialist, Charles River