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)
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, and infectious diseases.
- 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.
Capital investment in Takasaki Plant aimed at stable supply
In 2022, Kyowa Kirin decided to construct an active pharmaceutical ingredient (API) manufacturing building and a new warehouse building at its Takasaki Plant. In addition to a GMP compliant manufacturing facility, this new API building, HB7, will include a pilot facility for conducting scaled-up verifications of manufacturing. HB7 will employ a single-use design making it possible to apply the same equipment configuration from initial manufacturing process development to the production of investigational APIs. This in turn will allow for more flexible manufacturing of high-mix, small-lot products, including the rapid start of early phase clinical trials.
The new warehouse building will be constructed 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 formulations at room, cold or frozen temperatures.