Tosoh Bioscience Introduces TSKgel® FcR-IIIA-NPR Columns
Tosoh Bioscience GmbH announced today the introduction of its TSKgel FcR-IIIA-NPR HPLC column. This is the world’s first FcRγ affinity chromatography analysis column for antibody drugs and was developed independently by Tosoh Corporation.
World’s First Antibody Drug Activity Analysis Column
Monoclonal antibodies (mAbs) comprise the largest class 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 utilizes 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.
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