This division is responsible for the biopharmaceuticals including biotechnological products such as monoclonal antibodies, biosimilars, biological products, and polysaccharides, and exosome products that will be developed in the near future. 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 the standardization of analytical procedures for quality control, the establishment of test methods in Japanese Pharmacopoeia, and the official testing as an Official Medicine Control Laboratory. Advanced basic and applied studies related to this research are also being conducted.