In this webinar organized by Thermo Fisher Scientific as part of their “Leaders in BioPharma: Characterization and Control” series, Laurie Sansbury introduces the focus on Data Visualizations in Routine Host Cell Protein (HCP) Analysis by LC-MS. Andrew Williamson, a BioPharma sales expert at Thermo Scientific, draws on his experience with proteomics at the University of Manchester and his role in advancing LC-MS for biomarker discovery in oncology. He outlines the presentation’s focus on the technical challenges and solutions in identifying and quantifying HCPs, potential contaminants in biotherapeutics produced in non-human systems. Despite rigorous purification processes, residual HCPs can compromise the safety and efficacy of biotherapeutics, traditionally analyzed by ELISA, with LC-MS offering more detailed identification and quantification.

Andrew discusses the LC-MS analysis process, including the challenges such as the wide dynamic range of protein concentrations in samples and the necessity for robust sample preparation techniques. He highlights the use of Thermo Scientific’s Smart Digest kits for reliable and reproducible sample processing, crucial for overcoming these challenges. The presentation covers the setup of high-resolution accurate mass spectrometry and innovative software tools from Protein Metrics for efficient data processing and comprehensive report generation. These advances streamline the workflow, enhancing the accuracy of protein identification and quantification while supporting regulatory compliance and quality control in biotherapeutic development.