Under the clinical manufacturing agreement, Hitachi Chemical will make Daiichi Sankyo’s investigative product at its facility in Yokohama City, Kanagawa Prefecture.
The site houses Hitachi Chemical’s PCT regenerative cell-focused service platform, which its off-shoot Hitachi Chemical Co. America purchased from majority shareholder Caladrius Biosciences last year.
Regenerative medicine describes the process of transplanting in-vitro cells into patients to help restore organ or immune functions affected by disease. Regenerative approaches include immunotherapy and somatic stem cell therapies, engineered immune cell therapy and induced pluripotent stem cells (iPSC).
Daiichi Sankyo spokesperson Koji Ogiwara did not disclose which investigational drug will be manufactured by Hitachi Chemical, nor did he provide details on the manufacturing timeframe.
In October last year, Hitachi Chemical announced plans to add 49,700 sq. ft. to its PCT service site in Allendale, New Jersey, US.
The firm also announced plans to upgrade its Pearl Court site in Allendale, and confirmed its regenerative cell-focused CDMO site in Yokohama would be validated by April this year.