In May 2025, the U.S. Pharmacopeia (USP) officially published General Chapter <1132.1> titled "Residual Host Cell Protein Measurement in Biopharmaceuticals by LC-MS/MS." This marks a significant milestone for the biopharmaceutical industry, acknowledging the evolving role of Liquid Chromatography-Mass Spectrometry (LC-MS/MS) as a complementary technique to traditional Enzyme-Linked Immunosorbent Assays (ELISA) in Host Cell Protein (HCP) monitoring.
Why HCP Monitoring Matters?
Residual HCPs can compromise the safety, efficacy, and regulatory compliance of biopharmaceuticals. For decades, ELISA has been the gold standard for HCP detection due to its high sensitivity, selectivity, and ease of use in routine Quality Control (QC) settings. However, with increasing complexity in bioproduction processes, LC-MS/MS offers unmatched capabilities in identifying and quantifying individual HCPs, including those undetectable by antibody-based methods.