Services we provide in the field of cell & gene therapy
1. Contracted manufacturing of commercial products (CMO)
Manufacturing of commercial cell & gene therapy products, including CAR-T cells, in our PIC/S GMP-compliant facilities.
2. Process development and manufacturing of clinical products (CDMO)
Research, process development and manufacturing of clinical products, meeting the varied demands of academia, bio-ventures and pharma companies.
3. Quality control testing of CGT products for commercial, clinical and research use
Quality control tests in accordance with the US, EU and Japanese Pharmacopoeia and relevant GLP testing procedures as defined by regulatory agencies.
4. Consultation for regulatory issues
Comprehensive consultation service for issues regarding process development, the manufacturing process, and relevant regulatory issues so as to facilitate clinical trials and the obtaining of market approval.
|Representative||Shin Kawamata, MD, PhD, CEO|
|Location||1-5-4 TRI 3F, Minatojima-minamimachi, Chuo-ku, Kobe, Japan|
|Establishment||October 18, 2022|
|Employees||68 (as of April 1st, 2023)|
Message from Cyto-Facto
The Foundation for Biomedical Research and Innovation at Kobe (FBRI) was established in 2000 as a core organization to support the cluster of bio-medical companies in Kobe, Japan. The Research & Development Center for Cell Therapy (RDC) was established as the fourth center in FBRI in 2015. The goals of the RDC are to ensure the quality of cell products used in cell & gene therapy to facilitate regulatory approval and to provide cell manufacturing services as a CMO/CDMO for domestic and global biotech and pharma companies.
Beginning in April 2023, Cyto-Facto Inc. will take over the business activities of RDC as an FBRI spinout company. Cyto-Facto Inc. will take full responsibility for meeting the demands of society and the healthcare industry for reliable cell & gene therapy products.
We will continuously improve our service and our manufacturing technology to support the health of society by providing quality cell & gene therapy products to patients in a timely manner.
Shin Kawamata, MD, PhD
Chief Executive Officer