Host Cell Proteins (HCPs) are process-related impurities that originate from the cells used to manufacture biologic products. Monitoring HCP levels is an important part of biologics quality assessment.
Why HCP Testing Is Needed
- Evaluates product purity
- Supports process validation
- Helps meet regulatory expectations
Common Detection Methods
- HCP ELISA
- Mass spectrometry
- Western blot
For routine testing workflows, HCP ELISA is one of the most widely used methods.