By Dr Subhra Pradhan, Senior Scientist, GlycoSeLect

During the year 2020, IonDx collaborated with GlycoSeLect to develop a glycosylation analysis pipeline for biotherapeutics on their novel ion mobility spectrometry to help develop a quick and reliable glycan assay.

About glycans and glycosylation

Glycans are complex carbohydrate polymers that are found in glycoproteins, glycolipids, proteoglycans, monoclonal antibodies (mAbs), biologics, glycoconjugates and other important therapeutics. 

Glycosylation is the most common post-translational modification in eukaryotic systems and plays a vital role in a protein’s functional and structural aspects like folding, stability, immunogenicity, and half-life. It also influences several effector functions of biomolecules, such as product stability, antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and pharmacokinetics. For this reason, it is considered a Critical Quality Attribute (CQA) that needs to be disclosed to the regulatory bodies to confirm the safety and potency of therapeutics.

It is important to assess the glycosylation profile of a therapeutic molecule from early discovery to manufacturing phases. But glycan analysis can be challenging. The usual method requires its release from the protein by enzymes or by chemical processes to perform a mass spectrometry, which is expensive, time-consuming and labour-intensive.  

IonDx-GlycoSeLect collaboration

This is where GlycoSeLect’s technology can help pharmaceutical companies assess the glycan profiles without any release. Through our collaboration, IonDx has successfully applied our Recombinant Prokaryotic Lectins (RPLs) on their IMGenius ion mobility spectrometry platform to develop a novel glycan analysis.  

Some key outcomes of our collaboration: 

• The assays were developed using the Man2, α-Gal, Sia1, Sia3 and Fuc1 RPLs. 
• It enables quick glycoprofiling of biotherapeutics, requiring about 2 minutes per run. 
• The glycan analysis pipeline has been successfully applied to mAbs like Rituximab, Cetuximab, Bevacizumab, and NIST mAbs.  
• The signal generated by IMGenius platform due to mAb-lectin interactions were verified by simultaneous incorporation of de-glycosylation assays in the workflow. 
• The combination of IonDX technology and RPLs can provide a label-free, robust and rapid glycan analysis workflow to determine glycan abundance and changes, resulting in a highly efficient and selective way to monitor glycan changes in a bioprocess. 

We believe that the journey with IonDx has only started, and we are looking forward to a long-lasting joint venture. We are always ready to collaborate with recent technologies to move a step forward towards future innovations. For the GlycoSeLect family, each collaboration is an achievement.  

Thanks for your time and taking interest in our technology. Please do not hesitate to contact us at info@glycoselct.com if you are looking for a potential partner to answer questions about better glycoanalytics and glycoseparation.