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

Motivation

The analysis of protein glycosylation became of increasing importance in glycobiological research, as well as for bioprocess monitoring during development and production of biopharmaceuticals, like recombinant glycoproteins. In order to perform better and faster during discovery phase, R&D, (clinical) trials and approval of biopharmaceuticals and vaccines, automated high-throughput (HT) and high-resolution glycoanalysis methods are required.

Aim of the project

In particular, multiplexed capillary gel electrophoresis with laser induced fluorescence detection (xCGE-LIF) fits into the glycoanalytical needs and the tight time frames, when following systematic but laborious development concepts, like "Design of Experiment" (DoE) and/or "Quality by Design" (QbD), but also into QA/QC for all production stages up to product lot release. This technique - with up to 96 capillaries in parallel, results in massive reduction of the effective separation time per sample combined with an impressive sensitivity achieved by LIF detection - is applied within the scope of the listed collaboration partners.