When: Wed, Oct 7, 2020 12:00 PM - 1:00 PM EDT
Speaker: Ken Cook, Ph.D., European Team Leader for BioPharma/Pharma Expert Support, Chromatography and Mass Spectrometry Division, Thermo Fisher Scientific

Ken Cook

 Registration link: https://register.gotowebinar.com/register/2941928487859748876

The field of gene therapy is rapidly growing and introduces new challenges in the analytical characterization. Monoclonal antibodies are recognized as large molecules, but they are indeed dwarfed in comparison to the size of an intact viral particle. The full viral particle will contain an oligonucleotide payload which will also need to be characterized in addition to the protein capsid, bringing in additional analytical requirements. A further challenge to the analytical chemist is the reduced concentration of the sample in comparison to the mg/ml levels of monoclonal antibody in a therapeutic drug formulation. These problems and more will be addressed, showing the advances that have already been made and the future possibilities in a range of analytical characterization techniques used in gene therapy product analysis. Full and Empty ratio analysis, titer, component characterization, peptide mapping for PTM analysis with capsid ID and oligonucleotide analysis will be addressed, including UHPLC and LCMS possibilities.

Key Learning Objectives:
• UHPLC and HRMS based characterization techniques for adeno associated viruses
• Oligonucleotide separations

Who Should Attend:
• Method developers for UHPLC and HPLC methods supporting gene therapy characterization
• Method developers analyzing viruses and oligonucleotides