NOVEL HIGH-THROUGHPUT GLYCOANALYTICS FOR BIOPHARMACEUTICALS
More than two-thirds of biotherapeutics are glycosylated proteins, which includes the therapeutically important category of monoclonal antibodies. The development and manufacturing of these potentially life-changing treatments, however, carries a high risk of failure and is technically challenging and expensive. Glycosylation is a critical product quality attribute that impacts on the efficacy and safety of glycosylated biotherapeutics and, therefore, must be characterized and monitored throughout product development and manufacturing processes.
Key Learning Objectives:
- Review a simplified, rapid, high-throughput and cost-effective platform for characterization and monitoring of the glycosylation profile throughout development and manufacturing
- Learn about a novel approach for safety and potency assurance in biopharmaceuticals
- Use of Octet® platform for high-throughput detection of glycans in biopharmaceutical samples
Who Should Attend:
- Scientists, senior scientists, lab managers, lab directors, or principal scientists working in analytical development, cell line development, process development, bioprocessing, biologics manufacturing, biopharmaceutical quality control, biophysical characterization, protein characterization, titre/titer, potency, stability, or lot release
Victoria Smith PhD
Victoria Smith obtained a bachelor’s degree in microbiology at the University of Edinburgh and went on to complete the Wellcome Trust doctorate program at the University of Leeds. Her doctorate in structural biology and biophysics looked at the roles of protein misfolding in disease. As a post-doctoral researcher at the University of Leeds, she then specialized in the characterization of a virus assembly pathway by mass spectrometry. Vicky joined CPI in 2016 and she currently works as a principal scientist in analytical development. Her work involves the analytical characterization of a range of product types including recombinant proteins, monoclonal antibodies, viral vectors, and nucleic acids. Vicky specializes in mass spectrometry applications for protein characterization, including hydrogen deuterium exchange-mass spectrometry, peptide mapping, and glycan analysis.
Lewis is an experienced analytical scientist at CPI Biologics. He is focused on the development of analytical methods for the characterization of biologics, specializing in biophysical characterization, protein titre, purity, and stability. Lewis joined CPI in 2018 and has worked with a variety of biotherapeutics including nucleic acids, proteins, and viral vectors. He also has previous experience of working under GCP and GLP in the analysis of samples from clinical trials at Covance.