January 30, 2018 – Takara Bio’s Board of Directors resolved today to establish a new facility for the research and manufacturing of regenerative medical products in coordination with the expansion of existing research and manufacturing facilities at the company’s head office site in Kusatsu, Shiga.
Total project cost is expected to be around 7.3 billion yen, which is payable by cash on hand.
Takara Bio constructed a Center for Gene and Cell Processing in 2014 and the main building (new research building) at its Kusatsu facility in 2015, where it manufactures investigational drugs for its gene therapy clinical development projects and advances its regenerative medical product contract development and manufacturing organization (CDMO) business for regenerative medical products.
Gene therapy clinical development projects have been progressing smoothly and have now reached a stage where manufacturing can be scaled up in anticipation of market launch. Also, the CDMO business has seen an increase in contract service orders resulting from the effects of an increase in regenerative medical product development projects by pharmaceutical companies, bio-venture enterprises, and the like, and the expansion of the genome analysis diagnostic field, and the utilization rate of each facility has risen rapidly.
In consideration of this situation, Takara Bio has decided to establish a new facility in order to further advance its gene therapy clinical development projects and expand and develop CDMO business.
The new facility will be structured to facilitate contract service and R&D operations in three areas – the manufacturing of GMP/GCTP compliant regenerative medical products, quality testing, and operations such as genome editing and iPS cell manufacturing. With just the area with manufacturing equipment installed, the expansion enabled by the new facility will provide by approximately 2.5 times the contracted service sales recorded in fiscal 2016.
The new facility will have a total floor space of 14,100m2, and approximately 4,600m2 of this will not have manufacturing equipment installed, as it is designed to be used flexibly to respond to a diverse range of needs that may occur in the future. Furthermore, some functions from existing facilities will be transferred to and expanded in the new facility, and floor space in the existing facility for cell processing, cell bank storage, and gene analysis by a high-speed sequencer will be expanded. This plan will improve these functions and increase capacity.
Takara Bio will use this establishment and expansion of facilities as an opportunity to further develop and strengthen our operations according to the management objectives of “acquiring approval for the first gene therapy product in Japan” and “remaining number one for CDMO business involving regenerative medical products” as set forth in its Medium-Term Management Plan FY2020 (formulated May 9, 2017).