World’s First Antibody Drug Activity Analysis Column
King of Prussia, PA - Tosoh Bioscience LLC, a provider of chromatographic solutions for the separation of biomolecules, announced today the introduction of its TSKgel FcR-IIIA-NPR (non-porous resin) HPLC column. This is the world’s first FcRγ affinity chromatography analysis column for antibody drugs and was developed independently by Tosoh Corporation.
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 Fcγ receptor IIIa as a ligand bound to a non-porous 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 in the Americas from Tosoh Bioscience LLC.
TOSOH BIOSCIENCE LLC
Tosoh Bioscience LLC provides liquid chromatography products to laboratories and manufacturing plants in the Americas. While the majority of our customers work in biotechnology and pharmaceutical companies, our HPLC columns and systems are essential tools for sample analysis in most industries. Our all-in-one dedicated GPC system, the EcoSEC GPC System, is predominantly used in the chemical and polymer industries while our EcoSEC High Temperature GPC System is ideal for the polyolefin and oil industries. In the field of biotechnology, our preparative chromatography resins play a critical role in the purification of proteins and nucleic acids for medical purposes.
The company is a subsidiary of Tosoh Corporation in Japan, the parent of the Tosoh Group, which comprises over 100 companies worldwide and a multiethnic workforce of over 12,000 people and generated sales of ¥822.9 billion (US $7.4 billion at the average rate of ¥100.85 to the US dollar) in fiscal 2018, ended March 31, 2018.