Fujifilm Diosynth Biotechnologies was well along in the construction of its end-to-end biomanufacturing facility in Holly Springs, North Carolina, last November, when the facility recruited its first user from Janssen Supply Group. Johnson’s subsidiary
In the following months, J.
“We may still be expanding at our Danish plant. But for us it made more sense to expand to Holly Springs, because also in the Danish aspect we already have an expansion there,” Petersen said in an interview at the recent Biotechnology Innovation Organization (BIO) Foreign Convention, held in San Diego.
In addition to Hillerød in Denmark, Fujifilm Diosynth Ventura County in California (where the company has a site in Thousand Oaks, California) and Singapore before opting for Holly Springs, the Associated Press reported, filing a state document.
The company is completing an 11 billion Danish kroner (approximately $1. 6 billion) expansion of its facility in Hillerød, Denmark. The task transforms the facility into Europe’s largest end-to-end CDMO by strengthening the company’s mobile cultural production in Denmark and creating 450 new jobs. .
In Hollywood Springs, Fujifilm Diosynth is expanding its large-scale mobile culture facility by adding 8 x 20,000-liter (L) mammalian culture mobile bioreactors through 2028 to the 8 x 20,000-liter (L) bioreactors already planned for the bulk drug substance as a component of its initial $2 billion project with a budget of $2, which began in October 2021.
Fujifilm Diosynth will invest another $1. 2 billion in the North Carolina facility as a component of the expansion, which is expected to create an additional 680 jobs to the 725 the company plans to found in Holly Springs through 2027, generating just over 1,400 jobs. The company currently has around three hundred jobs.
Once completed, according to Fujifilm Diosynth, Holly Springs will be one of the largest mobile biopharmaceutical culture CDMO facilities in North America, with the ability to load more bioreactors based on demand from biopharmaceutical visitors.
The expansion is part of Fujifilm Diosynth’s “Partners for Life” strategy, which includes the creation of new large-scale production capacity in the United States and Europe, strengthening the resilience of the company’s supply chain. Through its KojoXTM modular production model, the company is building large-scale production facilities in the United States and Europe so that consumers can meet drug production desires in both geographies.
“The two facilities in Holly Springs and Denmark are 97 percent replica of each other, from a needs standpoint,” Petersen said. “This means that we are one of the few companies in the world that can move from one place to another. some other very quickly. “
Fujifilm Diosynth Biotechnologies is one of the CDMOs that meets the growing demand for outsourced production and others driven by large biopharmaceutical companies. And the company is rarely the only global CDMO in expansion mode.
In March, Lonza Group signaled plans to expand into the U. S. The U. S. government has acquired Genentech’s large-scale biologics production facility in Vacaville, Calif. , for $1. 2 billion from Genentech’s parent company, Roche. The deal is expected to be finalized in the second half of this year. A seven-hour drive north of Bend, Oregon, Lonza has expanded its service by providing spray drying of proteins for lung delivery, providing clinical and advertising production at the kilogram scale.
Another competitor of Fujifilm Diosynth, WuXi Biologics, has announced expansion plans that include expanding the capacity of its Worcester, Massachusetts, facility to 36,000 L, from the planned 24,000 L; and by installing a new pharmaceutical filling and filling line at its Leverkusen plant and doubling the capacity of the Wuppertal plant from 12,000 L to 24,000 L. In January, the company completed its first production at its MFG7 drug plant in Dundalk, Ireland. achieving a scale of 16,000 liters by combining 4 single-use bioreactors of 4,000 liters.
WuXi Biologics and other Chinese biotech corporations would face a significant loss of business in the U. S. UU. si Congress had voted and President Joe Biden would have signed into law the BIOSECURE Act (H. R. 7085), which would prohibit the award of federal contracts, adding the procurement of drugs for Medicare and Medicaid, to “warn foreign biotech corporations that pose national security considerations for the United States. “A revised edition of the measure filed last month would have allowed U. S. corporations to continue operating WuXi Biologics and other Chinese biotechs discussed in the bill until 2032.
But the long term of the BIOSECURE Act has become doubtful after it was not among the 350 amendments the Rules Committee agreed to add to the National Defense Authorization Act being drafted for federal fiscal year 2025, which begins Oct. 1. The congressional debate over BIOSECURE has raised doubts in the CDMO market, Fujifilm Diosynth claims to be among the corporations capable of addressing biopharma considerations.
“It actually has an effect on origin chains, and all corporations want to make sure they have mitigation plans and measures in place for it. There is a massive debate about the origin and, even before this debate, many patients around the world do not have the drugs, and we have just noticed that this number continues to grow,” Petersen observed.
“For more than five years, we have been at full capacity, especially since we started production on a giant scale. This means that when issues like the BIOSECURE Act pose risks, corporations are also asked to deal with greater challenges, in addition to their already full capabilities, which is the discussion around the BIOSECURE Act: how to ensure patient access to medicines?And I think we’re actually one of the corporations that’s well-positioned for that.
In Holly Springs, North Carolina, Fujifilm Diosynth is expanding its large-scale mobile culture facility by adding 8 20,000-liter (L) mammalian culture mobile bioreactors by 2028 to the 8 20,000-liter (L) bioreactors already planned for the bulk drug. as a component of your project. Initial $2 billion project, which began in October 2021. [Fujifilm Diosynth Biotechnologies] As for Holly Springs, Petersen claimed that a significant aspect in Fujifilm Diosynth’s resolution to expand its site was the company’s more than $72 million in economic benefits. incentives, the state of North Carolina, the North Carolina network school system, and local governments, adding Wake County and the city of Holly Springs.
State and local officials say they will largely recoup their spending, as the expansion is expected to increase the state’s gross domestic product by $4. 76 billion over 12 years and because the jobs created through Fujifilm Diosynth have an average salary of $109,923, about 47%. above the average Wake County annual salary of $74,866.
Wake County agreed to pay $30. 6 million, while Holly Springs will spend $23. 7 million on local infrastructure improvements. Holly Springs has agreed to spend $10 million in long-term asset taxes to fund investments in transportation projects throughout the city, adding a new “southern access” highway to be built at the Fujifilm Diosynth facility to reduce congestion on the Green Oaks Parkway.
The North Carolina Department of Commerce’s Economic Investment Committee (EIC) approved a 12-year Employment Development Investment Grant (JDIG) in the amount of approximately $15 million ($14,989,500), and the budget will be given to the company based on the tax profits generated. through the new projects. The state insists that its Commerce and Revenue departments will ensure that Fujifilm Diosynth has met its goals of increased project creation and investment before disbursing subsidies to the company.
In addition, the North Carolina Community College System has agreed to provide custom-designed skills education totaling $1. 7 million, while the state Department of Commerce’s Division of Workforce Solutions will contribute $1. 3 million to employment.
“Just like in real estate, it’s the location, the location, in economic progress, it’s the talent, the talent, the talent,” William O. Bullock, MBA, senior vice president of statewide economic progress and operations at the state-funded North Carolina Biotechnology. Centro. GEN Edge. Si you don’t have the talent, you’re not going to win those projects. Many other people own land. Many other people have infrastructure. Many other people benefit from incentives. We have all that too.
“I think we have two things that help us in this space,” Bullock explained in an interview with BIO 2024. One is a culture of collaboration between various public and personal entities. The other is the quality and duration of the life sciences workforce in North Carolina.
“We have the skills and we’ve been investing in those skills systems for 20 years, not just for a lot of smart graduates to move on to biology degrees, which we do. These are very specific four- and two-year programs. one-year systems in network schools that concentrate on bioprocessing and biomanufacturing.
The state bolstered its biomanufacturing education in 2022, when the North Carolina Center for Biotechnology led a statewide coalition of public and private organizations and institutions to win a nearly $25 million Phase II award in the U. S. Economic Development Administration’s Build Back Better Regional Challenge. U. S. The award aimed to promote biomanufacturing by developing, connecting, and selling educational and career opportunities to marginalized and suffering communities.
Bullock said North Carolina has about 37,000 jobs in the biomanufacturing sector, which is about a fraction of the state’s other 75,000 workers working in life sciences: “There’s a huge base that corporations like Fujifilm Diosynth can turn to to find a job.
This employment base is one of the key points in Fujifilm Diosynth’s arrival in Holly Springs, Petersen said.
“It is the network, the infrastructure, in all aspects, the resources, the training, the sustainability. The infrastructure overall has certainly been excellent,” Petersen said. “There’s no question that corporations decide in North Carolina.
Fujifilm Diosynth’s expansion to Holly Springs was announced in April, hours before Japanese Prime Minister Fumio Kishida kicked off a stopover in North Carolina that included stops at Toyota and HondaJet facilities. In October, North Carolina Gov. Roy Cooper led a state delegation to Japan.
Under Petersen’s leadership, Fujifilm Diosynth has restructured its operations into separate business sets aimed at supporting large- and small-scale biopharmaceutical consumers. The small-scale unit supports consumers who require bioreactors ranging from two hundred L to 2000 L, as well as single-use production systems. , while consumers of large-scale equipment want access to mobile bioreactors for the production of high-volume cultures of multiples of 20,000 L.
This large-scale activity has led to increased demand as biopharmaceutical giants have shifted production from in-house equipment to CDMO and accelerated the progression of Alzheimer’s drugs, Petersen said. However, demand from smaller customers has declined since COVID-19 moved. pandemic to endemic as venture capitalists scaled back early rounds of seed investment in favor of later, larger rounds targeting more established personal biotech.
Fujifilm Diosynth cited this decline in small-scale operations in April, when it carried out a restructuring in which the company eliminated 240 jobs at its College Station, Texas, facility; Raleigh, North Carolina; Watertown, Massachusetts; and Teesside, UK
“I would say that large-scale expansion has been particularly superior to small-scale expansion, although there has also been strong small-scale demand,” Petersen said.
Does this mean that small-scale production will soon grow again?
“Yes, we may just start to see it,” Petersen said. “We occupy what we have. Another is: you have to have skills. Lately we have a small-scale investment underway and we are ready to make additional investments. “But then you have the time you want to have it online.
Fujifilm Diosynth is also expanding its process development and production functions for mobile treatments in the Los Angeles suburb of Thousand Oaks, California, where the company is adding two new production cleanrooms to the existing three, transforming its existing GMP facility and expanding its warehouse. area. The expansion area will be operational next year.
The Thousand Oaks assignment is one of two mobile treatment expansion assignments totaling $200 million for parent company Fujifilm. The company is also building a new 175,000-square-foot headquarters for its subsidiary Fujifilm Cellular Dynamics in Madison, Wisconsin, which is scheduled for completion. in 2026 (Fujifilm acquired CDI in 2015 for $307 million). The new headquarters will feature an expanded procedure progression laboratory and an existing GMP (cGMP) facility for mobile therapies; structure of 3 new blank rooms that will be added to the 3 existing blank rooms; as well as a progression area, a production facility and a mobile warehouse for the support of the progression of medicines.
The end of June will mark Petersen’s first year as CEO of Fujifilm Diosynth. He assumed leadership of the company from the position of COO of Hillerød, Denmark and head of its large-scale strategic business unit. Prior to joining Fujifilm Diosynth in 2019, Petersen held leadership positions at Biogen, Novo Nordisk, and Genentech.
“It’s been wonderful,” Petersen said of his year as CEO of Fujifilm Diosynth. “It’s a transition when you’ve never been CEO before. I’ve been with the company for how long, five years?I was part of the control team, but the CEO still feels like he has a new task after 11 months.
It’s too early to celebrate, he warns: “The anniversary is a few weeks away. “