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FBRI Commences Renovation for New Contract Manufacturing Facility for Cells in Order to Accelerate Development of Cell and Gene Therapy Treatments

September 13, 2021

Foundation for Biomedical Research and Innovation at Kobe (FBRI) will renovate the fifth floor of the Kobe Center for Medical Innovation (KCMI) at the Kobe Biomedical Innovation Cluster (KBIC), creating the Kobe Cell Manufacturing Innovation Center (tentative name), which will serve as a manufacturing facility carrying out contract manufacturing of cells for corporations engaged in developing cell and gene therapy treatment. The approximately 1,300-m2 floor will become the largest cell manufacturing facility at KBIC. The facility is planned to house multiple cell processing and culture rooms to support contract manufacturing, along with a cell quality inspection lab.

Name of Facility:Kobe Cell Manufacturing Innovation Center (tentative name)
Renovation Period:August 2021 - January 2022
Scheduled Completion Date:February 2022
Location:Fifth Floor of Kobe Center for Medical Innovation (KCMI)

Since 2003, Research & Development Center for Cell Therapy (RDC) at FBRI has been involved in contract manufacturing of cells at the cell processing facility of the Institute of Biomedical Research and Innovation (IBRI)’s research wing, which is located in the area. With global initiatives to develop cell and gene therapy treatment increasing, there has been a steady rise in consultations from corporations regarding contract manufacturing for cell development and clinical trials. To support this corporate demand for cell and gene therapy treatment development, the fifth floor of the KCMI will be renovated with a contract cell manufacturing facility. This plan is expected to attract corporations that are aiming to develop their gene/cell manufacturing business to KBIC, and the endeavor is certain to contribute to further advancements.

Since its establishment in March 2000, FBRI has been the core support body of KBIC, serving a comprehensive coordinating role that promotes partnerships and integration among industries, academia, government, and medical institutions. FBRI’s basic mission is to contribute to the creation of innovative medical technologies and to integrate medical and medical-adjacent industries, which it does through R&D activities that help lead to cutting-edge medical treatments, through support for clinical applications, and through the creation of next-generation medical systems.

RDC’s mission is to provide development support for medical seeds relating to cell therapy (including cell therapy research, regenerative medicine research, and production of therapeutic cells), and to establish business for cell preparation manufacturing. The center is involved in developing promising basic seeds through clinical research, utilizing the neighboring research and medical infrastructure concentrated in the Kobe Port Island area. From basic research to pharmaceutical development, the center provides broad support for pharmaceutical research using cell preparations. In November 2020, the center began its commercial production for Novartis’ Kymriah® Intravenous Infusion. It is one of the most advanced gene therapy products in the world. In addition to contract manufacturing, the center R&D initiatives include cell safety test methods and evaluations, and development of next-generation automatic culture systems.