A new Madison stem cell manufacturing plant could have a significant impact on the Wisconsin medical landscape and the field of regenerative medicine, along with the local economy.
In January, Fujifilm Cellular Dynamics Inc., a U.S. subsidiary of Japanese electronics manufacturer Fujifilm Corp., announced plans to build a $21 million plant across the street from the company’s headquarters at 525 Science Drive. The facility is expected to be operational by March 2020. FCDI also has a facility in Novato, California.
Although in November the company reduced its staff by 10 percent, cutting marketing, sales and administrative jobs in an effort to focus its resources on the applications of regenerative medicine, chief executive officer Seimi Satake said the company does plan to hire more skilled employees soon.
“We are planning to increase staff in the near future,” he said.
In 2015, Fujifilm Holdings Corp. purchased Cellular Dynamics International Inc., a company founded by developmental biologist James Thomson in 2004, for $307 million. Thomson, director of regenerative biology at the Morgridge Institute for Research in Madison and a University of Wisconsin-Madison professor, is best known for his work with isolating human induced pluripotent cells, or iPSC.
“It is very encouraging that Fujifilm Cellular Dynamics is making this long-term investment here in Wisconsin. It reflects the strengths of the Madison community in biotechnology and stem cell research,” Thomson said.
Satake said the company, in part, chose Madison as the site of the plant due to the city’s abundance of skilled medical professionals, particularly in the regenerative medicine field.
Madison is home to several medical and biomedical facilities, among them the University of Wisconsin School of Medicine and Public Health and Waisman Biomanufacturing.
“We value the strong connections we have made with the city, state and partners, such as the University of Wisconsin, and we see many possibilities for FCDI in Madison,” Satake said. “The area is rich in talent and expertise.”
Like embryonic stem cells, iPSC can be applied to many treatments in regenerative medicine, including cancer, Parkinson’s disease, heart disease, age-related macular degeneration and retinitis pigmentosa, without the controversy and ethical considerations associated with embryonic stem cells.
FCDI’s four cell therapy programs, which focus on treating congestive heart failure, different types of cancers, Parkinson’s disease, and ocular diseases and conditions, “were developed to address unmet patient needs, (in instances) where replacement of dead and damaged cells can create positive outcomes,” Satake said.
What he refers to as the company’s “advancing therapies” pipeline would focus on these medical needs.
According to Satake, manufacturing and developing the extremely sensitive iPSC cells is highly complicated. Workers must have very specialized skills similar to those involved in color film processing, including “precisely arranging over 100 types of compounds across 20 photosensitive layers in a thickness measuring just 20 microns.”
“Furthermore, Fujifilm’s image processing technology with machine learning can be applied to improve productivity in both the development and manufacturing processes. For instance, the system can provide stable predictability for iPSC to change certain cell types,” Satake said.
In addition to the company employing direct manufacturing for iPSC cells, Satake believes FCDI’s plans to provide contract manufacturing will help the company maintain growth. It is aiming to evolve the stem cell therapies to human trial level within the next two to three years.
“The facility is designed to accomplish several stages of clinical study. As the programs advance, we will scale up the facility,” Satake said.
Madison-area experts feel the new FCDI plant will benefit the city economically by providing jobs for University of Wisconsin graduates and other skilled workers.
“Any new biomanufacturing effort like this provides new opportunities for our students and faculty, including new jobs and new opportunities for public-private R&D partnerships. This increased local investment from Fujifilm is an endorsement of our biomanufacturing ecosystem, which continues to thrive here in Wisconsin,” said William Murphy, Harvey D. Spangler Professor of Biomedical Engineering, professor of orthopedics and rehabilitation, and director of Forward BIO Institute at the University of Wisconsin-Madison.
David Gamm, chief scientific officer and co-founder of Madison-based Opsis Therapeutics, in which FCDI is an investor, believes the new plant will help cement Madison’s reputation as a leader in the field of regenerative medicine and advanced medical technologies.
“This is an important facility for us, as it gives yet another option in Madison for generating clinical-grade cell products,” Gamm said. “As such, we are in a great position to build a strong footing in cell therapeutics.”
According to Opsis co-founder Carter Cliff, its mission is “to advance iPSC-manufactured retinal cell therapies.” Benefitting patients is one of the program’s key aims.
“The medical community will be engaged over time as we endeavor to establish safety and efficacy of our candidate products. We have established a Scientific Advisory Board of thought leaders that includes UW faculty and clinicians,” Cliff said.
Satake asserts that staying ahead of the regenerative medicine curve is one of FCDI’s main long-term goals.
“Fujifilm will continue to be on the leading edge and plans on expanding facilities to meet the needs of regenerative medicines and contract development manufacturing organizations businesses,” he said.
