The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. In the development of downstream processes, the use of effective assays to determine both the concentration of the product and the quantity and concentration of host cell proteins present is imperative. The assays used should accurately monitor changes in the product concentration and the removal of host cell proteins after purification.
This webinar highlights HCP testing regulations, the risks of using a non-appropriate HCP method, and different assay approaches that are available.
- Olaf Stamm, PhD, MDRA, Sr. Business Development Specialist, Charles River