Facility of the Year Awards, An ISPE Program

Takara Bio Inc. is the 2016 ISPE Facility of the Year Winner for Facility Integration for their Center for Gene and Cell Processing Construction Project located in Kusatsu, Japan.

Takara Bio Inc. operates in three core areas:  bio-industry, agri-bio, and gene therapy.  In June 2012, prompted by the Japanese government’s policy to encourage the development of regenerative medicines, the company initiated construction of the Center for Gene and Cell Processing (CGCP) to serve as a core facility for CMDO business.  The goal of the CGCP was manufacturing and testing biopharmaceuticals, as well as investigational products for gene and cell therapies.

Company Mission:
Contributing to the health of humankind through the development of
revolutionary biotechnologies such as gene therapy

Traditionally, facilities for manufacturing gene therapy products and regenerative medicines, such as cell products, viral vectors or recombinant proteins, are not placed within the same building in order to eliminate any risk of cross-contamination. However, the goal of this project was to achieve the world’s first “one-stop GMP manufacturing facility” that can combine three facilities (cells, viruses, and proteins) into one, with each area having separate entrances for personnel and raw materials, preventing the intersection between them. Furthermore, the air conditioning at each area is controlled independently, which completely segregates areas. These innovations made it possible to successfully construct a facility that can handle cells, viruses, and proteins within the same building.

The CGCP facility was constructed unlike any other in the world, as one that can handle upstream bacterial culture as well as manufacture different types of gene therapy products and regenerative medicines such as viral vectors, recombinant proteins, antibodies, and cell products within the single facility. The CGCP is located in the base of the corporate headquarters area enabling them to operate manufacturing at the CGCP facility more efficiently under the direct control from the headquarter office.

The first floor is designed for an upstream culture area with three bioreactor suites for manufacturing recombinant proteins and plasmid DNA. The second floor consists of a virus manufacturing area with six manufacturing suites, purification area with two rooms and aseptic filling area with three rooms. The third floor is designed for a cell processing area with five cell processing suites (plus three for future expansion) for manufacturing gene modified cells or regenerative medicines, and a quality and safety testing area with 16 rooms for testing bio-products.

The CGCP facility integration has the potential to become a global standard for a “one-stop GMP manufacturing facility” in the pharmaceutical and regenerative medicine industries.

ISPE congratulates the Takara Bio team for their achievements and win for Facility Integration. Learn more about Takara’s Center for Gene and Cell Processing Construction Project.

Join ISPE and prominent industry leaders as we recognize the 2016 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the FOYA Banquet on the evening of Tuesday, 7 June 2016 in North Bethesda, MD during the ISPE/FDA/PQRI Quality Manufacturing Conference.