The mAb-Glyco Chip Kit - a Workflow Solution for Rapid and Fully Automated Characterisation of N-linked Glycans from Monoclonal Antibodies

Monoclonal antibodies (mAbs) are an important class in the group of new biological entities with about 30 antibody drugs licensed for treatment of various diseases [1]. These glycoproteins bear complex oligosaccharide moieties within their structure, whose presence, absence, and profile can have significant impact on therapeutic efficacy, pharmacokinetics, and immunogenicity. Glycosylation is influenced by many factors such as the cell line in which the mAb is produced as well as specific production parameters including pH or temperature. Thus, characterisation of glycan profiles is of vital importance throughout the various phases of drug development.

The challenge for the analytical chemist is that conventional methods utilised are complex and time consuming. For instance, a typical workflow could involve multiple sample preparation steps: Enzymatic deglycosylation of mAbs, hydrolysis of

glycosylamines to free reducing end glycans, and (dependent on the detection method) the labelling of glycans with fluorescent tags. Glycan analyses apply capillary electrophoresis or HPLC with fluorescence and/or MS detection, or MALDI-TOF-MS.

Together with data acquisition and processing the chemist is looking at one half to several days to complete the analysis [2]. In addition, if sample preparation is done manually, each step exhibits a potential source of error.