Kusatsu/Shiga Japan – January 21, 2020 – Takara Bio Inc. (Takara Bio), announced completion of a new facility, the Center for Gene and Cell Processing II (new facility) for the research and manufacturing of regenerative medicine products in Kusatsu, Shiga and operation start since January 2020.

 

  Takara Bio constructed a Center for Gene and Cell Processing in 2014, where it advances CDMO business supporting for the development and manufacturing of regenerative products and manufactures investigational drugs for our own gene therapy projects. In recent years, CDMO business has been growing significantly along with a global reach on developing the regenerative medicine products for gene therapy, posing an issue with insufficient capacity for manufacturing in our existing facility and developing in the R&D facility. Further, the steady development of our gene therapy projects has necessitated scaled-up manufacturing in anticipation of market launch, thereby we have established a new facility in order to further meet business expansion as decided in January 2018.

 

  The new facility has a total floor space of 14,500 m~{2}, more than twice the size of already-existing facility, and operates GMP/GCTP-based manufacturing in accordance with the standards for Manufacturing Control and Quality Control for regenerative medicine products and pharmaceuticals. Further, Takara Bio plans to obtain accreditation of specific processed cells and a third party certificate like ISO9001 quality management system.

 

  Takara Bio will accelerate CDMO business and our own gene therapy project through this operation, aimed at a drug discovery company to create new modalities with biological platform technology.

【Reference】

Takara Bio to Establish a New Facility for the Research and Manufacturing of Regenerative Medical Products (Released on January 30, 2018)

https://ir.takara-bio.co.jp/en/news_all/news_Release/news_Release2404159330868269856.html

 

【Facility Overview】

Facility Name

Center for Gene and Cell Processing II

Location

7-4-38 Nojihigashi, Kusatsu, Shiga 525-0058

Facility and Business
  • Total floor area 14,500 m~{2}
  • Contract service for manufacturing of regenerative medicine products and quality testing
  • R&D for new technology of regenerative medicine products
  • Technology development and manufacturing related to research reagents
  • Vector manufacturing, cell processing, cell banking, GMP aseptic filling

【External View and Layout】

 

 

【Headquarters located in Kusatsu, Shiga Pref. : Layout】