Japanese firm Kyowa Kirin has decided to build a new active pharmaceutical ingredient (API) manufacturing building (HB7 Building) at its Takasaki Plant that is responsible for manufacturing biopharmaceuticals.

The HB7 Building will manufacture APIs for biopharmaceuticals utilizing Kyowa Kirin’s unique antibody technology and protein engineering, and it will be equipped with both a GMP compliant manufacturing facility and pilot facility for investigational APIs in early phase development.

Because both facilities are planned to have the same single-use manufacturing equipment, it will be possible to use the same equipment configuration for every step from the initial process development for biopharmaceutical API manufacturing to the manufacturing of the investigational API.

This will enable even quicker supply of investigational APIs, and it is ultimately expected to facilitate a rapid start of early phase clinical trials.

Also, through the construction of the HB7 Building, Kyowa Kirin will possess its own manufacturing facility for early phase development, enabling more flexible high-mix, small-lot manufacturing of products in early phase development.

Construction is planned to be completed in April 2024, and the facilities will be successively brought online from June 2024 as preparations are complete. Manufacturing of investigational APIs is planned to start from 2025 onwards.