Japanese pharmaceutical and biotechnology company Kyowa Kirin Co Ltd (TSE:4151) announced on Friday that it has completed the construction of a new Drug Substance (DS) manufacturing Facility (HB7 building) at its biopharmaceutical manufacturing site Takasaki Plant (Takasaki city, Gunma Prefecture).

The HB7 building is designed to manufacture DS for biopharmaceuticals utilising Kyowa Kirin's antibody technology and protein engineering. It will be equipped as a GMP compliant manufacturing facility for the investigational drugs in early phase development, and pilot facility for process development. In addition to having the same manufacturing equipment, these GMP and pilot facilities also utilise single-use technology, which reduces the risk of cross-contamination between products without the need to spend time of cleaning verification or validation. This is expected to lead to an early supply of investigational drugs and accelerate development.

Additionally, the building is designed with space for future expansion, to enable the smooth introduction of next-generation manufacturing technologies such as continuous production, as well as new challenges including automation and digitisation, with the aim of realising a smart factory in the future. A training facility for the manufacturing and quality control of biopharmaceuticals has also been established.