Automated Online Monitoring and Quality Control of Glycan Profiles from Various Antibodies Using Ultrahigh-Resolution QTOF Mass Spectrometry
The industrial manufacturing of a monoclonal antibody is generally preceded by a process developing phase that can take several years to complete. During this work, it is crucial to achieve sufficient understanding of the design space and its impact on the drug substance specifications. Software and analytical tools that can facilitate the fast and accurate acquisition of this knowledge are required to save valuable downstream resources.
High-resolution mass spectrometry is a powerful tool for the monitoring of quality attributes related to a typical bioproduction process. This, due to its high sensitivity, specificity and exceedingly short assay time. However, for mass spectrometry to reach full compatibility with the production environment, an robust, integrated analytical platform (including easy to use, open access software) is required, which provides automated online sampling, sample handling and enrichment of the target molecule as well as instant data evaluation.
In this work, we present a standalone analytical platform developed for the direct connection to a bioreactor with subsequent high-resolution mass spectrometric detection (including the latest in Biopharma software), for real time, at-line monitoring, of monoclonal antibody quality. The platform performance for glycoprofile measurement was evaluated on various commercial molecules incubated in cell culture fluid.