This division is responsible for the biopharmaceuticals including biotechnological products such as insulins, growth hormones and monoclonal antibodies, biological products, and polysaccharides. In order to ensure the quality, safety and efficacy of these products, we engage in their experimental preparations, the development of methods for their characterization (in terms of their structure, physicochemical properties, immunochemical properties and biological activity, etc.), as well as in viral safety evaluation, the standardization of analytical procedures for quality control, and the establishment of test methods in Japanese Pharmacopoeia. Basic and applied biochemical studies related to this research are also being conducted.

Examples of substrates used for manufacturing biotechnological products

Characterization of biotechnological products: The structure of carbohydrate moieties and the receptor binding properties of monoclonal antibodies are analyzed by liquid chromatography/mass spectrometry (LC/MS) and surface plasmon resonance (SPR) spectroscopy, respectively.

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