Elucidation of Glycosylation Patterns of Recombinant Glycoproteins for Production, Process Control and Optimization

The analysis of protein glycosylation is of increasing importance in glycobiological research as well as for monitoring and quality control in development and production of biopharmaceuticals. In order to perform better and faster during the discovery phase, R&D, (clinical) trials, and approval of recombinant proteins and vaccines, automated high-throughput (HT) and high-resolution glycoanalytics is mandatory.

In particular, multiplexed capillary gel electrophoresis with laser induced fluorescence detection (xCGE-LIF) fits into glycoanalytical needs and tight time frames when following systematic but laborious development concepts, like "Design of Experiment" (DoE) and/or "Quality by Design" (QbD). In addition, xCGE-LIF can be used to support QA/QC at all production stages up to product lot release. CGE, which can be operated with up to 96 capillaries in parallel, results in a massive reduction of the effective separation time per sample combined with an impressive sensitivity achieved by LIF detection. The scope and performance of the technique is reflected by the high number of collaboration partners.