The Research & Development Center for Cell Therapy (RDC) of the Foundation for Biomedical Research and Innovation at Kobe (FBRI, President: Dr. Tasuku Honjo) is announcing that manufacturing equipment installed on the fifth floor of the Kobe Center for Medical Innovation (KCMI) in the Kobe Biomedical Innovation Cluster (KBIC) for manufacturing cells by contract for companies that develop pharmaceuticals for cell and gene therapies will start operations on March 1, 2022.
The Research & Development Center for Cell Therapy has been manufacturing approved regenerative medical products (Novartis's Kymriah®) by contract, developing research infrastructure for clinical trials, and providing consulting on regulatory affairs regarding cell therapy and on cell processing centers (CPCs), and the Center has established a CMO business compliant with PIC/S GMP. The Center is also involved in developing a next-generation cell manufacturing system. By using the knowhow, the Center has cultivated to establish facilities and services for quickly and fully performing sponsored clinical trials, and supports the establishment of commercial manufacturing for these companies.
Details of Facilities
The floor area is about 1,300 m2, making this the largest cell manufacturing facility in the Kobe Biomedical Innovation Cluster. It includes the following five areas.
① Central QC area
The Quality Control (QC) room is located near the cell manufacturing area. When quality tests are performed during manufacturing for clinical trials, the Center's QC department promptly handles stages from the receipt of test samples through delivery.
② Three cell manufacturing areas
The facility has three cell manufacturing areas compliant with PIC/S GMP. The staff have knowledge and experience of international regulations, and their roles in the contract business include manufacturing, QC, and facility operations. In these manufacturing areas, manufacturing control for clinical trials or commercial uses can be smoothly transferred to the companies in accordance with their needs.
③ Solution Lab
The laboratory is equipped with a CellQualia™ -Intelligent Cell Processing System-, which is an automated closed system for cell manufacturing from SINFONIA TECHNOLOGY CO., LTD. You can experience cell manufacturing work with this next-generation cell manufacturing system. It uses information collected from related QC devices, environmental monitoring, etc., and it is based on the Quality by Design (QbD)*1 concept.
The aforementioned facilities will be used by companies such as HEALIOS K.K., etc., to manufacture cells. Additionally, demonstrations are planned for Cocoon™, an automated closed platform for manufacturing from Lonza for cell therapy drugs, which is the first installment in Japan.
Location & Access
Facility：Kobe Center for Medical Innovation (KCMI）
Location：6-3-5, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo 650-0047
Access： Port Liner 「Keisan Kagaku Center」 Station
Comments from Dr. Shin Kawamata, Head of the Research & Development Center for Cell Therapy
The Research & Development Center for Cell Therapy of the Foundation for Biomedical Research and Innovation at Kobe had been performing cell contract-manufacturing at the cell processing center in the research building of the Institute of Biomedical Research and Innovation since 2003. Because activities for the development of cell and gene therapies have been recently increasing around the world, we have gradually been having more consultations with companies regarding cell development and cell contract manufacturing for clinical trials. Accordingly, in order to meet the expectations of companies involved in the development of cell and gene therapies, we established a cell contract-manufacturing facility on the fifth floor of the Kobe Center for Medical Innovation. By opening this cell processing facility, the Center will endeavor to help further development of such companies in need. We hope that you have an opportunity to visit us.
Shin Kawamata, M.D., Ph.D.
Head of Research & Development Center for Cell Therapy
Foundation for Biomedical Research and Innovation at Kobe
About the Research & Development Center for Cell Therapy
The Research & Development Center for Cell Therapy's role is to research cell therapies and regenerative medicine, support the development of medical resources for manufacturing cells for therapeutic use, and establish a cell manufacturing business. The Center uses the nearby research and medical infrastructure of the Kobe Port Island area while developing promising fundamental resources as a part of clinical research, and it provides broad support for basic research up through pharmaceutical development of cell manufacturing. In November 2020, the Center was the first in Asia to start commercial manufacturing of Novartis's Kymriah®, one of the world's most advanced gene and cell therapy products. In addition to contract manufacturing, the Center also performs research and development for cell safety test methods/testing as well as development, and for next-generation automatic culturing systems.
For details on the Research & Development Center for Cell Therapy, visit the website.
Explanation of terms
*1 Quality by Design (QbD)
During cell manufacturing, there is variation in the quality of the cells used for raw materials and in the raw materials used for media, etc., in manufacturing processes, and manufacturing conditions vary with these conditions and the passage of time. QbD is an approach to manufacturing that includes analyses of these fluctuations, an identification of their relationship with the quality of the final product, and the setting of allowable ranges.