Host cell protein (HCP) profiling is a core component of large molecule biopharmaceutical protein characterization. To ensure the safety of protein drug products, these residual impurities must be measured, monitored, and controlled to set specifications during biotherapeutic manufacturing.
Greg Kilby, Vice President of Technology and Bioanalysis at Alliance Pharma, discusses the emerging role that LC-MS/MS is playing as an orthogonal tool to help identify and quantify these impurities with exquisite sensitivity.
