This state-of-the-art facility is designed to support the early-phase development of biopharmaceuticals and is equipped with both good manufacturing practices (GMP)-compliant and pilot-scale manufacturing areas.
JAPAN—Kyowa Kirin has announced the completion of its new drug substance (DS) manufacturing facility, the HB7 building, at its Takasaki plant in Gunma Prefecture, Japan.
This milestone marks a significant step forward for the company as it seeks to strengthen its global biopharmaceutical manufacturing capabilities.
The HB7 building represents a substantial investment of 16.8 billion Japanese yen, which is approximately $118 million.
This state-of-the-art facility is designed to support the early-phase development of biopharmaceuticals and is equipped with both good manufacturing practices (GMP)-compliant and pilot-scale manufacturing areas.
These areas utilize single-use technology, which helps minimize the risk of cross-contamination and streamlines the production process.
This approach not only improves safety but also accelerates the development and early supply of investigational drugs, allowing Kyowa Kirin to respond more quickly to patient needs.
In addition to its manufacturing capabilities, the HB7 building includes a dedicated training facility to address Japan’s shortage of experienced biopharmaceutical engineers.
This training space is outfitted with equipment that allows staff and trainees to simulate actual manufacturing processes, providing hands-on experience that closely mirrors real-world operations.
This initiative builds on Kyowa Kirin’s Human Resource Development Office, established at the Takasaki site in 2022, and aims to further enhance the company’s training programs by combining classroom learning with practical, on-site instruction.
The facility has been designed with future growth in mind, allocating space for potential expansion.
This will facilitate the integration of next-generation manufacturing technologies, including continuous production, automation, and digitization.
These features align with Kyowa Kirin’s vision of creating a “smart factory,” where advanced technologies drive efficiency and innovation in drug manufacturing.
The building itself spans four floors above ground and one below, covering a total floor area of approximately 9,250 square meters.
Kirin Engineering Company and Taisei Corporation managed the construction of the HB7 building, ensuring that the facility meets the highest standards of quality and safety.
The completion of this project is part of Kyowa Kirin’s broader strategy to establish a global manufacturing network.
In June 2024, the company also announced the construction of a new biopharmaceutical plant in Sanford, North Carolina, USA, with an investment of up to US$530 million.
This new U.S. facility will be scalable and designed to facilitate technology transfer between the Sanford and Takasaki sites, further strengthening Kyowa Kirin’s in-house ability to manufacture drug substances from early development to market launch.
Moreover, in January 2025, Kyowa Kirin completed the acquisition of Orchard Therapeutics for an equity value of US$477.6 million, further expanding its footprint and capabilities in the biopharmaceutical sector.
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