The efficacy of protein drugs is determined by which sugars are attached to the molecule.Erythropoietin (EPO), for example, is eliminated from the body too quickly to have a therapeutic effect unless all the sugars bound to the molecule are capped with sialic acid.
Bound sugars can also provoke a harmful reaction from a patient’s immune system. For example, alpha gal groups or N-glycolylneuraminic acid - which are added to biopharmaceutical molecules by some non-human production cell lines - are immunogenic in humans.
As a result the International Conference on Harmonisation (ICH) guideline Q6B calls on biopharmaceutical firms to characterise the carbohydrate content of their candidate compounds as extensively as possible. The US FDA and EMA encourage similar analysis.
This is something of a challenge according to Agilent and researchers from A*STAR’s Bioprocessing Technology Institute (BTI), which argue that current glycan analysis methods are time consuming and hard to apply in a commercial setting.
To that end Agilent and A*STAR aim to develop faster, more accurate glycan testing methods by combining the former’s sample prep and screening technologies with the latter’s processing and glycoprotein production knowhow.
BTI research scientist Zhang Peiqing said: “Bringing together expertise from Agilent and BTI will allow us to develop an approach for analysis of therapeutic glycoproteins that requires lesser user intervention while keeping to the high standards of analysis needed.”
This was echoed by BTI executive director Lam Kong Peng, who added that: “This collaboration will help build glycomics capabilities in Singapore and is part of process analytical technologies relevant to the biomanufacturing industry.
“Ultimately, this partnership will enhance Singapore's reputation as a world-class destination for biopharmaceutical R&D and manufacturing” he added.