Kyowa Kirin has completed the construction of its new drug substance (DS) manufacturing facility, the HB7 building, at its Takasaki plant in Japan.
Investment in the HB7 building totals Y16.8bn ($117m), reflecting the functions of the building in manufacturing, research of biopharmaceutical DS, and staff training.
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The facility leverages the company’s protein engineering and antibody technology.
Kyowa Kirin’s HB7 building comprises a good manufacturing practices-compliant facility for early-phase investigational drug development and a pilot plant for process development.
The facilities leverage single-use technology to minimise cross-contamination risks, potentially accelerating the development and early supply of investigational drugs.
The building includes an area for potential future expansion for new manufacturing technologies such as continuous production, along with digitisation and automation, aligning with the company’s vision of a smart factory.
A training facility for biopharmaceuticals’ manufacturing and quality control features equipment enabling trainees to carry out similar simulations of the company’s manufacturing process.
To address the shortage of experienced biopharmaceutical manufacturing engineers in the country, the company has set up a specialised human resource development office at the Takasaki plant since 2022.
The HB7 building improves the company’s training programmes, combining classroom-based and practical learning to cultivate talent.
The Kirin Engineering Company designed the facility, while construction services were provided by the Kirin Engineering Company and the Taisei Corporation.
Kyowa Kirin chief supply chain officer, managing executive officer Toshiyuki Kurata stated: “In June 2024, we also announced to build a biopharmaceutical plant in Sanford, North Carolina, US, and construction is currently underway.
“By establishing a global manufacturing structure that utilises the Takasaki plant, including the HB7 building, and the plant in Sanford, we aim to further accelerate development by manufacturing DS in-house, from early to late-stage development and the initial stages of market launch.”
In January 2025, Kyowa Kirin announced the completion of its acquisition of Orchard Therapeutics for an equity value of $477.6m.
