Tosoh Bioscience has introduced its TSKgel FcR-IIIA-NPR high-performance liquid chromatography (HPLC) column.

This is one of the world’s first FcRγ affinity chromatography analysis columns for antibody drugs and was developed independently by Tosoh Corporation.

Monoclonal antibodies (mAb) comprise one of the largest classes of glycosylated protein therapeutics currently on the market and glycosylation is known to be a major source of mAb heterogeneity. Glycosylation is a critical factor in drug product solubility, kinetics, stability, efficacy and immunogenicity.

The TSKgel FcR-IIIA-NPR column is a high-performance affinity chromatography column for the analysis of IgG glycoforms. The stationary phase utilises a recombinant human Fcg receptor IIIa as a ligand bound to a nonporous polymethacrylate polymer. The resulting elution profile of the glycoprotein mimics antibody-dependent cellular cytotoxicity (ADCC) activity, which is correlated to the composition of the N-glycans.

A rapid thirty minute separation allows the analysis of large numbers of mAb samples to gain valuable initial information on the distribution of glycoforms and expected ADCC activity. This initial and efficient method can be applied to purified samples and supernatant alike and can, therefore, be used in many phases of development and production such as cell line screening in early R&D, biosimilar/originator comparison, upstream development and optimization, monitoring of glycoengineering, or lot-to-lot comparison in QC.

TSKgel FcR-IIIA-NPR columns are now available for sale.