FCDI is proud to offer contract development and cGMP manufacture of clinical-grade human cells to advance your cell therapy program.
iPSC Technical Expertise
For over a decade, we have been the industry leader in the development, manufacturing, testing, and distribution of iPSC-derived products. We offer:
- Expertise deriving iPSCs from many different cell and tissue types including PBMCs, CD34+ progenitors, T cells, MSCs, and cord blood.
- GMP compliant reprogramming processes to generate clinical-grade iPSCs using proprietary, non-integrating plasmid technology.
- Inventory from over a dozen donors covering common HLA types in the US
- GMP compliant banking and characterization of clinical grade products. Including established iPSC scale-up methods to routinely manufacture > 10 billion iPSCs per batch
FCDI Advanced Cell Technology and Manufacturing Expertise
FCDI offers world-leading technology and experience in iPSC technology, genetic engineering, assay development and differentiation to a broad range of cell types.
- Built on our expertise in developing dozens of products in our life science and therapeutic business portfolios
- Extensive experience in the translation of research grade protocols to GMP-compliant, scalable processes
- Established methods using closed system, controlled bioreactor systems
- Capacity to produce cells at commercial scale to speed cell therapies to market
- Assay development capabilities that utilize cutting edge methods including molecular, cellular and bioinformatics platforms.
- Custom cell characterization
It is the unfortunate reality that heart disease is still the number one cause of death globally. There are many laboratories around the world focused on this unmet medical need, including the development of iPSC-derived cardiac cell therapies. Utilizing our space at our Innovation Facility for Advanced Cell Therapy (iFACT), our scientists have optimized our cGMP differentiation process across iPSC lines. FCDI is already the world leader in supplying cardiomyocytes for drug discovery research and is now leveraging its core technology to help advance the development of cardiac disease treatments.
iPSC-derived Neural Cells
50 million Americans are affected yearly with neurodegenerative disease. At FCDI, we are leveraging our technologies and know-how to generate dopaminergic neural progenitors for a cell replacement therapy, as the first pipeline for our therapeutic neural program. FCDI aspires to produce scaled clinical-grade neuronal/glial cell therapy products for the repair and/or replacement of human brain tissue(s) to cure a multitude of neurodegenerative diseases.
iPSC-derived Immune Cells
In addition to CAR-based immunotherapies for oncology, FCDI aims to produce clinical-grade immune therapies for indications such as autoimmune disorders. Additionally, immune cells can be leveraged as an intersectional therapeutic platform with other FCDI therapeutic programs, for example microglia from the FCDI neural program. FCDI scientists have developed both small and large-scale manufacturing platforms for the immune portfolio, to produce cells to treat a range of diseases.
iFACT - The Innovation Facility for Advanced Cell Therapy
FUJIFILM Cellular Dynamic’s new 31,500 ft.2 (2,926 m2) state of the art facility was 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