Stable Supply

Stable Supply of Pharmaceuticals

Kyowa Kirin has put in place the following framework in a bid to ensure the stable supply of high-quality pharmaceuticals in line with global expansion.

  • Production and supply frameworks for medium- and long-term demand
    • Develop demand forecasts for proprietary products, establish and implement production plans
    • Explore potential pharmaceutical production and storage sites to support the global supply framework
    • Mitigate production and supply risks associated with growth in a number of sales countries / regions
    • Planned expansion of production facilities
  • Revolutionize production technology to boost efficiency and create added value
    • Develop drug production / formulation technologies that translate into competitive advantages
    • Automize and digitize production processes / production management
    • Develop processes for bispecific antibodies and other new compounds
    • Develop appropriate drug forms in LCM (Life Cycle Management)

Risk Management

Addressing such Events as Disasters

Based on the global, all-hazard BCP guidelines established in 2021, we are strengthening our business continuity framework to prepare for various events, including earthquakes, windstorms, floods, infectious diseases and cyber incidents.

  • In the event of a disaster, a response headquarters is established, and a system put in place to examine initial as well as short- and long-term responses.
  • The Group also takes steps to consider a second source for important raw materials and to adjust inventory levels.
  • The Group determines the appropriate number of months of inventory for APIs, intermediates, and products, while also building up inventories.

Specific Initiatives

Capital investment in Takasaki Plant and a new plant in Sanford aimed at stable supply

In March 2025, Kyowa Kirin completed construction of drug substance (DS) manufacturing building at its Takasaki Plant. In addition to a GMP compliant manufacturing facility, this new DS building, HB7, includes a pilot facility for conducting scaled-up verifications of manufacturing. HB7 employs a single-use design making it possible to apply the same equipment configuration from initial manufacturing process development to the production of investigational DS. This in turn will allow for more flexible manufacturing of high-mix, small-lot products, including the rapid start of early phase clinical trials.Furthermore, Kyowa Kirin is constructing a new plant for DS manufacturing in Sanford, North Carolina, USA. Once construction of this plant is complete, the HB7 Building and the plant in Sanford will ease technology transfer from development to market launch by having scalable facilities at both site, which is expected to further accelerate development. Additionally, we are working to ensure a stable supply of global products that will expand in the future with the strengthening of our Business Continuity Plans (BCPs).
In Takasaki Plant, the new warehouse building is under construction to accommodate the increased supply of biopharmaceuticals (products and developments) and comply with the standards required by each regulatory authority for the storage of biopharmaceutical raw materials, drug substances, and drug products at room, cold or frozen temperatures.