At these four laboratories and factory, we combine our capability to develop production technologies for biological pharmaceuticals, including antibody pharmaceuticals, and capability to produce biological investigational products.
Mission: To perform process development of biotechnology-based medical products, manufacture of investigational new drugs and formulation design of drug products.
Endeavoring to establish world-leading production technology of biotechnology-based medical products as well as producing new biological investigational products, including antibodies. We consistently maintain a responsibility for research and development into manufacturing process necessary for New Drug Application for approval of the manufacture of medical products.
Mission: Manufacturing investigational new drugs and designing drug preparations for small molecule pharmaceuticals.
Medical products are administered to patients in any number of forms, from tablets and capsules to dry syrups for infants and injectable solutions. At the Drug Preparation Laboratories, research and development continues for preparations matching the qualities of new drugs, preparations adjusted to their target uses and diseases, and preparations easily used by patients and practitioners. We are also striving to develop new forms of medicine, through Drug Delivery Systems (DDS), extended release capsules and drugs which can be taken easier. The development of mass-production scale drug preparation processes to put to actual use in our factories is another key function of the Drug Preparation Laboratories. By using drug preparation facilities based on the concept of Good Manufacturing Practices (GMP) we can manufacture investigational drugs for use in clinical testing and play a vital part in the development of medical products.
Mission: Engaging in research to enlarge the scale of synthetic manufacture of drug candidate compounds towards industrial production.
Research is made to refine the manufacture of medical products, looking to enlarge the scale of synthetic manufacture of drug candidate compounds towards industrial production and to optimize production processes. Higher-quality medical products are developed and highly reliable pharmaceutical ingredients are provided by ensuring manufacturing processes take into account responsible care (concern for the environment and for safety, utilizing advanced, highly functional and safe equipment.
Mission: Production management, manufacture, quality control and quality assurance of medical products (largely drug substance and drug product).
This is a state-of-the-art plant conforming to Good Manufacturing Practice, which is international standards for quality control and manufacturing management of medical products. The factory utilizes unique technology of Kyowa Hakko Kirin developed over a long period of the history of the company. Main products are ESPO® and NESP®, a erythropoietic stimulant agent, GRAN®, a G-CSF, and Busulfex®, a pretreatment drug for hematopoietic stem cell transplants. A fully comprehensive system is in place for quality control to ensure we continue to produce trustworthy medical products.