A new behemoth is entering the cell therapy CDMO market, FUJIFILM Cellular Dynamics (FUJIFILM CDI). CDMOs are companies that provide manufacturing services to cell and gene therapy companies on a contract basis. In some cases, they may also support product development, clinical trial support, or commercial supply.
On January 3, 2019, FUJIFILM Cellular Dynamics, Inc. (FCDI), a US subsidiary of FUJIFILM Corporation, announced it will be spending $21M to open a new cGMP-compliant production facility in Madison, Wisconsin. According to FCDI, the facility will support FCDI’s internal cell therapeutics pipeline, as well as serve as a Contract Development and Manufacturing Organization (CDMO) for iPS cell products.
iPS Cell Manufacturing for Regenerative Medicine
Induced pluripotent stem cells (iPS cells) are differentiated cells that are reprogrammed back into an embryonic-like state. Derived from skin or blood cells, iPS cells are not controversial, because they are made from adult cells. As pluripotent stem cells, they can give rise to nearly all of the tissues that form the human body.
The market for iPS cell therapies is rapidly expanding, with Cynata Therapeutics recently completing the world’s first Phase I trial with an iPSC-derived therapeutic product (CYP-001). In January 2017, FUJIFILM took a strategic equity stake in Cynata Therapeutics of 9%, for which it paid A$3.97 million. Under the agreement, the parties are collaborating on the development and commercialisation CYP-001 for graft-versus-host disease (GvHD).
Additionally, Fate Therapeutics is positioned to launch the world’s first trial with an iPSC-derived therapeutic product within the United States, following the FDA’s November 2018 approval of its IND Application for FT500. FT500 is a universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line.
There are also numerous physician-led studies underway in Japan exploring the use of iPSC-derived therapies for the treatment of macular degeneration, Parkinson’s disease, heart disease, and the production of human platelets.
FUJIFILM CDI’s Regenerative Manufacturing Expertise
With a market cap of U.S. $22B, Fujifilm is undoubtedly the global behemoth within the regenerative medicine space.
Over the past several years, FUJIFILM has been strengthening its presence in the regenerative medicine field by acquiring a portfolio of strategic assets. First, it controls the leading regenerative medicine company in Japan, Japan Tissue Engineering Co. Ltd. (“J-TEC”). J-TEC successfully launched the first two regenerative medicine products in Japan. As a result of this experience, it has tremendous knowledge and “know how” related to cGMP facilities.
With the acquisition of Cellular Dynamics International (CDI) in March 2015 for $307 million, FUJIFILM then gained entry into the area of induced pluripotent stem cell (iPSC) based cell discovery, development support, and services to businesses. Through this acquisition, it acquired critical cell technology and science to support high-volume cell manufacturing.
Next, FUJIFILM Corporation acquired Irvine Scientific Sales Company (ISUS) and IS JAPAN CO.,LTD. (ISJ), leading companies in cell culture media, for approximately $800 million in June 2018.
As FUJIFILM stated in its March 2018 announcement:
- Combining CDI’s iPS cell preparation technologies, J-TEC’s somatic stem cell culturing technologies, and ISUS and ISJ’s cell culture media technology (that is capable of developing optimal customized cell culture media), CDI and J-TEC will be able to efficiently prepare high-quality therapeutic cells and apply them to regenerative medicine products.
- Utilizing the ISUS and ISJ’s cell culture media and technologies, CDI and J-TEC will ensure more efficient production of regenerative medicine not only for in-house production, but also for contract manufacturing business.
Finally, FUJIFILM’s controls FUJIFILM Wako Pure Chemical Corporation, whose has expertise in the reagent business, as well as FUJIFILM Diosynth Biotechnologies U.S.A. and FUJIFILM Diosynth Biotechnologies UK Limited, businesses that conduct CDMO services for biopharmaceuticals.
What is clear from this M&A activity is that FUJIFILM is accumulating a robust portfolio of assets that will position it to be the global leader in regenerative medicine.
iPS Cell Manufacturing Facility
To leverage the expertise of its portfolio companies, the goal of FCDI’s cGMP-compliant production facility will be to industrialize iPS cell manufacturing for regenerative medicine therapies. It is scheduled to initiate manufacturing operations in March 2020.
As stated by Seimi Satake, Chairman and CEO of FCDI:
“To meet the growing demand for FCDI’s iPS cell platform, the state-of-the-art production facility will have a flexible cell culturing design to serve production requirements of both industrial quantities of cells, and small, diverse batches. By combining Fujifilm’s experience gleaned from the intricate process of manufacturing photographic film along with FCDI’s knowledge of cell reprogramming, genetic engineering and cell differentiation, the facility is poised to address the complex manufacturing processes of cell therapies.”
Cell and Gene Therapy CDMOs
Among cell and gene therapy companies, the pressure for manufacturing innovation and optimization can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise, such as cell therapy contract manufacturing organizations.
Benefits of partnering with a cell therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. With dozens of companies now specializing in manufacturing and clinical trial support for cell and gene therapies, demand for these services is expanding.
Following the announcement of its $21M cGMP manufacturing facility, FUJIFILM CDI is positioned to be the leading global manufacturer of therapeutic-grade iPS cell products. It also positions FUJIFILM CDI to expand its own regenerative medicine pipeline.
To see who else is competing within the cell and gene therapy CDMO marketplace, view this searchable, sortable Database of Cell and Gene Therapy CDMOs.
iPSC Market Report
Seeking an understanding of current iPSC market opportunities? View the Global Induced Pluripotent Stem Cell Industry Report, published January 2019.
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