HCP ELISA And HCP Antibody Coverage Analysis Methods

By Alla Zilberman, Biopharma Insights Contributor, Vice President, Technical Marketing at Cygnus Technologies

Host cell proteins (HCPs) constitute a major group of process-related impurities in biological drugs produced using cell culture technology. HCPs are produced inadvertently during the expression of recombinant biopharmaceuticals as secreted from host cells from aberrant cellular trafficking due to cell stress and cell lysis over the course of bioprocess manufacturing. Many HCPs are benign, but some are immunogenic; some may interact with the drug substance, and others, like proteases and lipases, can reduce effective product dosage through direct action on the drug or its stability by interfering with formulation buffer. Since HCPs can pose a risk to patients and affect the efficacy and stability of the drug, read how they constitute a significant component of a biopharmaceutical drug developer’s overall risk-management strategy (1, 2).