Announcement of Participation in AMED Project “Research and development of core technologies for gene and cell therapy”

Kusatsu/Shiga, Japan — October 22, 2018 – Takara Bio Inc. announces that it is participating in “Research and development of core technologies for gene and cell therapy” (Project) undertaken by Japan Agency for Medical Research and Development (AMED: https://www.amed.go.jp/en/index.html) since FY2018, under which Takara Bio will work on the development for large-scale production technologies of virus vector for gene therapy through joining in “Manufacturing Technology Association of Biologics” (http://cho-mab.or.jp/english/).

Also, we announce that the Centralized R&D lab for Project will be established in our headquarters region of Kusatsu, Shiga Prefecture.

With the recent progress in technology development of gene and cell therapy and satisfied requirements for safety and effectiveness in preceding overseas clinical trials, the clinical development is globally getting active. Also, the clinical development aiming for commercialization is actively being conducted in Japan as well. There is a huge issue in the development and establishment of large-scale production method of carrier called vector for delivering the therapeutic gene to cell or lesion site (mostly detoxified virus) for practical application. For the purpose of addressing the issue, Project aims to promote research and development on technology and others in producing on a large scale and improving safety of virus vector intended for the advanced gene and cell therapy in Japan’s all-out effort, and further to develop Japan’s useful technologies and products.

Takara Bio has plenty of track records in manufacturing the clinical vectors through in-house gene and cell therapy projects and CDMO business which handles development and production support for regenerative medicine products. With technologies and know-how accumulated by those experiences, we will participate in Project for the purpose of engaging in development of the useful technologies in producing of prospective vector on a large scale through connection with academic institutes and companies in Japan. With establishment of the Centralized R&D lab to integrate the elemental technologies owned by academic institutes and companies participating in Project, our facility (1st floor of two-story building, Total area about 1,000 m²; Kusatsu, Shiga) will be lent to Manufacturing Technology Association of Biologics.

【Project Outline】

Takara Bio focuses on the commercialization of our gene and cell therapy products and CDMO business supporting the development and manufacture of regenerative medical products, and is aiming for further expansion of these businesses through participation in Project.