Tokyo, Japan— As of February 2019, Tosoh Corporation has launched sales worldwide of its TSKgel® FcR-IIIA-NPR. This is the world’s first FcγR affinity chromatography analysis column for antibody drugs. It is designed to analyze the structure and activity of antibody drugs and was developed independently by Tosoh.
TSKgel FcR-IIIA-NPR uses the human Fcγ receptor IIIa as a ligand. Filled with an Fc receptor immobilized packing material, the column enables antibody separation based on the differences in the carbohydrate structure of an antibody that is affecting antibody-dependent cellular cytotoxicity (ADCC).
The biopharmaceutical industry is expanding not only in Japan, the United States, and in other advanced countries in Europe, but also in emerging nations, such as China and India. And demand for antibody drugs is robust. In the research and development of, and manufacturing of antibody drugs, analyzing the activity of antibodies that serve as active pharmaceutical ingredients is essential.
Tosoh offers an assortment of high-performance liquid chromatography (HPLC) and ultrahigh-performance liquid chromatography (UHPLC) columns ideally suited for antibody analysis in antibody drug R&D and manufacturing. Tosoh will continue to bring new products to market to further the profitability of its bioscience business.
1. Characteristics of TSKgel FcR-IIIA-NPR
Unique separation: TSKgel FcR-IIIA-NPR’s unique separation characteristics enable the recognition of dynamic behavior changes of Fc region caused by the differences of antibody N-linked glycoforms, and the separation of antibodies of differing ADCC activity. The column tends to retain antibodies displaying high ADCC activity.
Excellent stability: Fc receptor stability is improved significantly by molecular modification using protein engineering technology. The stable Fc receptor allows accurate and reproducible analysis.
Short-time analysis: Direct analysis of the antibody molecules can be achieved in as short a time as 30 minutes.
2. Characteristics of antibody drugs
Characterized by high therapeutic effect and minimal side effects, antibody drugs are increasingly used worldwide to treat cancer and autoimmune diseases, such as rheumatoid arthritis. They are expected to have the highest rate of growth among biopharmaceuticals.
The difference in the carbohydrate structure of antibody drugs affects their binding affinity with Fcγ receptor IIIa expressed on the surface of immune cells and their antibody activities such as ADCC activity that destroys cancer and other cells.
* A portion of this research was partially supported by the department of innovative drug discovery and development at the Japan Agency for Medical Research and Development (AMED), which is focused on developing key technologies for discovering and manufacturing drugs for next-generation treatment and diagnosis (Issue No. JP17ae0101003)
TOSOH CORPORATION
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Tosoh is the parent of the Tosoh Group, which comprises over 100 companies worldwide and a multiethnic workforce of over 12,000 people and generated net sales of ¥822.9 billion (US$7.4 billion at the average rate of ¥110.85 to the US dollar) in fiscal 2018, ended March 31, 2018.
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Tosoh is one of the largest chlor-alkali manufacturers in Asia. The company supplies the plastic resins and an array of the basic chemicals that support modern life. Tosoh’s petrochemical operations supply ethylene, polyethylene, and functional polymers, while its advanced materials business serves the global semiconductor, display, and solar industries. Tosoh has also pioneered sophisticated bioscience systems that are used for the monitoring of life-threatening diseases. In addition, Tosoh demonstrates its commitment to a sustainable future in part by manufacturing a variety of eco-products.
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