Host Cell Proteins Detection Various Assays

Host Cell Proteins (HCP) are proteins unrelated to the intended biologics but to host organisms used for biologics production. The composition and abundance of these HCP are multifactorial.

Nevertheless, their detection and characterization is of great importance for the safety of biologics before their administration in volunteers and patients.

Various detection assays are used such as based on:

  • electrophoresis SDS-PAGE
  • classical dosages for total protein amount & residual DNA
  • Western Blot
  • ELISA (commercial or in-house kits)
  • mass spectrometry identification (using LC-MS/MS Orbitrap after enzymatic digestion and an analysis based on protein databases)