The market of biologics in Biopharma companies is in constant evolution and moved away in the last few years from classical monoclonal antibody to proteins that are more difficult to analyze, such as therapeutics proteins, antibody drug/molecule conjugates and even in the cell and gene therapy space with Adeno Associated Viruses for example. With all these new modalities, state of the art analytics must be developed to characterize them in details and mass spectrometry is a major player in this arena. Native MS applied to heterogeneous biotherapeutics like ADC and other complex format is heavily used.
More recently Charge Detection Mass Spectrometry (CD-MS) has become commercially available as Thermo Scientific™ Direct Mass Technology™ mode on the Thermo Scientific™ Q Exactive™ UHMR mass spectrometer. Methods have been developed and applied on Biotherapeutics Beasts in the half Megadalton to 3-4 MDa range to measure AAV Full:Empty genome ratio.
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Presented by Thierry Besson, Senior Scientist II, Novartis Institutes for Biomedical Research