Alpha-gal (Gal-alpha(1-3)-Gal) is a disaccharide fragment found on the glycans of some glycoprotein therapeutics produced in mammalian expression systems – particularly those from mouse-derived cell lines.
Galα1-3Gal is a non-human epitope that has caused adverse clinical reactions (including IgE-mediated anaphylaxis) in patients. It could also lead to diminished clinical efficacy due to increased serum clearance.Gal-alpha(1-3)-Gal is a high priority
Glycosylation Critical Quality Attribute (GCQA) and developers of biologic drugs should effectively optimise, measure and control the glycosylation of their products to limit Galα1-3Gal levels throughout the product life cycle.
View Ludger Alpha-Gal Poster – WCBP 2016
“Procainamide labelling as part of a flexible glycoprofiling system for monitoring of Gal-α1-3Gal related Glycosylation Critical Quality Attributes (GCQAs) of monoclonal antibody (mAb) therapeutics throughout the product life cycle.”Radoslaw P Kozak, Louise Royle, Li Phing Liew, Daniel I R Spencer and Daryl L Fernandes