FUJIFILM Cellular Dynamics (FCDI) is proud to offer process development and cGMP manufacture of clinical-grade human cells to advance your cell therapy program.
One-stop shop for CDMO services for your iPS cell therapies
We offer innovative development and manufacturing services from early development to market supply, and
from drug substance to drug product across a variety of iPSC-derived cell types.
Advanced Cell Technology and Manufacturing Expertise
FCDI offers world-leading iPSC-derived cell therapeutic GMP manufacturing and regulatory submission experience with products currently in clinical trials. Our expertise and experience enable us to provide:
- Technology transfer of a wide variety of both small-scale processes and clinical-scale manufacturing
- Cell Line engineering and gene editing
- Process & analytical development and optimization
- Cell banking and therapeutic clinical manufacturing in GMP suites
- Internal QC release, characterization and stability testing of cell banks and manufactured products
- CMC regulatory support
Partnered Programs
- FCDI has been manufacturing cell therapies for our partners starting from FUJIFILM CDI’s iPSC lines, in immune oncology, neurodegenerative disease and retinal disease.
- Additionally, we have provided regulatory support for partners’ IND filings.
FUJIFILM Extracellular Vesicles Total Solution
FCDI is a part of a FUJIFILM consortium for services in extracellular vesicle therapeutic development and manufacturing.
For more details click here.
iFACT - The Innovation Facility for Advanced Cell Therapy
FCDI’s 31,500 ft.2 (2,926 m2) state of the art facility is designed and built to support the development and GMP compliant manufacture of cell therapy products for early phase clinical trials. The facility contains all of the necessary features to advance cell therapy products into the clinic. To this end, the facility boasts:
- 4 separate development laboratories
- 3 independently operated GMP manufacturing suites
- Dedicated quality control laboratories to support cell line characterization, PCR assays, microbiology and raw material testing
- Controlled warehouse space with ambient, 2-8 °C, -20 °C, -70 °C and liquid nitrogen storage
Advanced Features of iFACT
The facility has additional design features intended to ensure secure, reliable and continuous operation, including:
- Single-pass HEPA filtered air throughout the entire facility
- Facility-wide backup generator to support continuous operation during power outage
- Utility systems for air, CO2, O2 and N2 process gases, bulk liquid N2 and a centralized vacuum system
- Controlled security access
New Facility to Open in 2026
- Multi-product GMP area for cell therapy manufacture
- 175,000 ft.2 facility
- 3 independently operated GMP suites with a larger overall footprint than current GMP space
- Flexible design – no fixed equipment
- Suitable for Phase III clinical and commercial manufacture
