Advanced Analytical Methods for Host Cell Impurities

This eBook explores the growing analytical challenges of managing host cell protein (HCP) impurities in biopharmaceutical manufacturing, with particular focus on complex biologics such as gene therapies and CHO-derived products. It examines the evolution of HCP analytics from early ELISA and Western blot methods to advanced orthogonal approaches combining Antibody Affinity Extraction (AAE™) with mass spectrometry, which enable more precise identification, coverage analysis, and absolute quantification of high-risk HCPs. A featured study demonstrates the utility of a parallel reaction monitoring (PRM) assay using stable isotope-labeled peptides to quantify six CHO HCP lipases at sub-ppm detection levels.