The Essential Role Of High-Quality Anti-Host Cell Protein (HCP) Antibody Reagents

Therapeutic proteins are typically manufactured using host cell expression systems such as mammalian (CHO or HEK), bacterial (E. coli), or yeast cells. Alongside the desired therapeutic protein, these host cells naturally produce their own proteins to sustain cellular function. During bioprocessing, residual host cell proteins (HCPs) can co-purify with the product, making their detection and removal a critical requirement at every stage of the pipeline. Careful monitoring of HCP content is essential to ensure product efficacy, safeguard patient safety, and minimize adverse immune responses (immunogenicity).

A key component of this process is the generation of high-quality HCP antibody reagents, which enable reliable detection and quantification of impurities to maintain product purity and regulatory compliance. Yet, the accurate measurement of HCPs remains a significant analytical challenge for the biopharmaceutical industry, requiring robust strategies and advanced methodologies to achieve the necessary sensitivity and specificity.