Advanced Technologies and Methods to Monitor, Control, and Quantify Host Cell Proteins

Host cell protein (HCP) analytics have evolved dramatically over the past 25 years from early “black box” approaches with only semiquantitative outputs to advanced mass spectrometry (MS) methods capable of identifying every HCP in a drug substance. Although HCP ELISAs remain semiquantitative, they are no longer opaque. This paper demonstrates how leveraging advanced technologies ensures that both generic and process-specific ELISAs are fit for purpose and support data-driven risk assessments for product safety. It also highlights case studies on HCP antibody coverage analysis using 2D-PAGE and MS-based approaches, along with new data from the Cygnus CHO Lipase Assay using stable isotope–labeled peptides and PRM-MS absolute quantification.