TOKYO, December 4, 2023 – FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announces the investment of USD 200 million in two subsidiaries to significantly expand global cell therapy contract development and manufacturing (CDMO) capabilities. The investment will enable Fujifilm to support the expanding cell therapy market which is anticipated to grow by more than 30% per year up from USD 3.3 billion in FY20221.

The $200 million investment in cell therapy manufacturing capabilities is earmarked for both the new headquarters of FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC) and iPSC-derived cells, and the California site of FUJIFILM Diosynth Biotechnologies, a world-leading CDMO in biologics and advanced therapies.

Cell therapies are a promising treatment modality with the ability to augment, repair, and/or replace human biology, including organs, tissues and cells. According to Alliance for Regenerative Medicine’s sector data, there are more than 500 ongoing clinical trials for cell therapies globally2. This investment will strengthen Fujifilm’s manufacturing capacity to support iPSC-derived cell therapies, as well as Cytotoxic T lymphocyte (CTL), Chimeric antigen receptor (CAR), T-cell receptor (TCR), Natural killer (NK) and tissue-derived therapies.

The investment will fund FUJIFILM Cellular Dynamics’ new 175,000 sq. ft headquarters in Madison, Wisconsin, U.S.A., located in BioMidwest, a hub of life science companies and academia. The new campus located at 8402 Excelsior Drive will house iPSC cGMP3 manufacturing with three clean room suites, process development laboratories, warehouse operations and administrative space. This investment will double the Company’s existing manufacturing capacity for the development and commercialization of iPSC-derived cell therapies for its partners. The new site will also include iPSC manufacturing for research and development applications for drug discovery, drug efficacy, and pharmacology. The full site including cell therapy manufacturing will be operational in spring 2026.

The investment in FUJIFILM Diosynth Biotechnologies’ site in Thousand Oaks, California, U.S.A., located near a major cluster of pharmaceutical, biotech, and venture capital firms, will fund the site expansion with a new development lab and two new independent manufacturing clean rooms, significantly increasing production capacity for new client programs. The talent at the California site has strong experience in clinical and commercial manufacturing of in vitro cell lines, targeting a wide variety of cell therapies. The added capacity will be operational in early 2025.

“This investment is an important step for Fujifilm to lead as an innovative global manufacturing partner for the growing cell therapy market. The combined resources of the Fujifilm Group will enable us to meet the diverse and expanding manufacturing needs of our customers,” added Teiichi Goto, president and chief executive officer, representative director, FUJIFILM Corporation. “We look forward to supporting our customers in manufacturing cell therapies that address unmet medical needs and contribute to the advancement of human health worldwide.”


Summary of Investment

1. Name FUJIFILM Cellular Dynamics, Inc.
2. Location Madison, Wisconsin, U.S.A.
3. Investment Details New headquarters with development, manufacturing, and distribution facilities, and expansion of process development and manufacturing capabilities 

-Expansion of process development laboratory and cGMP facility for cellular therapeutics

(manufacturing clean rooms from 3 to 6: 3 clean rooms at the current site will be maintained)

-Development, production facility and warehousing of cells for drug development support

4. Total Floor Area Approx. 175,000 sq. ft
5. Start of Construction November 2023
6. Operation Period 2026

 

1. Name FUJIFILM Diosynth Biotechnologies California, Inc.
2. Location Thousand Oaks, California, U.S.A.
3. Investment Details Expansion of process development and manufacturing capabilities 

-Expansion of laboratory and GMP facilities for process development of cellular therapeutics (3 manufacturing clean rooms → 5)

-Remodeling of existing GMP facilities, expansion of warehouses, etc.

4. Start of Construction 2024
5. Operation Period 2025

 

[1] Fujifilm estimates based on Evaluate Pharma ®Nov2023 cell therapy market growth rate from 2022 to 2030.
[2] Alliance for Regenerative Medicine [Website]. Available at “https://alliancerm.org/wp-content/uploads/2023/10/Trials_final_Q2.pdf” [accessed 22 Nov 2023]
[3] Abbreviation for current Good Manufacturing Practice which are regulations enforced by the FDA