News

Article

Pharmaceutical Technology's In the Lab eNewsletter

In the Lab eNewsletter

Pharmaceutical Technology\'s In the Lab eNewsletter-03-06-2019
Volume14
Issue 3

Affinity Chromatography Analysis Column for Antibody Drugs

The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience is a FcRγ affinity chromatography analysis column suited for the analysis of immunoglobulin G glycoforms.

The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience, a provider of chromatographic solutions for the separation of biomolecules, is a FcRγ affinity chromatography analysis column for antibody drugs.

The column is suited for the analysis of immunoglobulin G (IgG) glycoforms. The stationary phase uses a recombinant human Fcγ 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.

According to Tosoh, 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 company reports.

A rapid thirty-minute separation allows the analysis of large numbers of mAb samples to gain initial information on the distribution of glycoforms and expected ADCC activity. This initial method can be applied to purified samples and supernatant alike and can be used in various 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 quality control.

Source: Tosoh Bioscience

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content