Fujifilm Diosynth Biotechnologies was well into construction of its end-to-end biomanufacturing facility in Holly Springs, NC, last November when the facility signed up its first user in Janssen Supply Group. The Johnson & Johnson subsidiary committed to a large-scale manufacturing suite at the biopharmaceutical manufacturing facility that the Fujifilm subsidiary is building in the Tar Heel State, which is set to be fully operational in 2025.
In the months that followed, demand from J&J and other companies convinced the global contract development and manufacturing organization (CDMO) that it needed additional manufacturing capacity. Lars Petersen, president and CEO of Fujifilm Diosynth, told GEN Edge the company considered adding that capacity in Europe and other regions of the world before concluding it was best instead to grow the Holly Springs site.
“We could still expand in our Danish site. But then it made most sense to expand in Holly Springs, because also on the Danish side, we have expansion going on there already,” Petersen said in an interview during the recent Biotechnology Innovation Organization (BIO) International Convention, held in San Diego.
In addition to Hillerød, Denmark, Fujifilm Diosynth considered California’s Ventura County (where the company has a site in Thousand Oaks, CA) and Singapore before choosing Holly Springs, the Associated Press reported, citing a state document.
The company is completing a DKK 11 billion (about $1.6 billion) expansion of its Hillerød, Denmark facility. The project is transforming the facility into the largest end-to-end CDMO in Europe by adding to the company’s cell culture manufacturing services in Denmark and creating 450 new jobs.
In Holly Springs, Fujifilm Diosynth is growing its large-scale cell culture facility by adding eight 20,000-liter (L) mammalian cell culture bioreactors by 2028 to the eight 20,000 L bioreactors that were already planned for bulk drug substance as part of its initial $2 billion project, which broke ground in October 2021.
Fujifilm Diosynth will invest an additional $1.2 billion in the North Carolina site through the expansion, which is projected to add 680 more jobs to the 725 the company expects will be based in Holly Springs by 2027, resulting in just over 1,400 jobs. The company now bases about 300 jobs at the site.
Upon completion, according to Fujifilm Diosynth, Holly Springs will be one of the largest cell culture biopharmaceutical CDMO facilities in North America, with flexibility to add additional bioreactors based on demand from biopharma clients.
The expansion is part of Fujifilm Diosynth’s “Partners for Life” strategy, which calls for building out new large-scale production capacity in the U.S. and Europe, thus enhancing the resiliency of the company’s supply chain. Through its KojoXTM modular production model, the company is constructing identical large-scale production facilities in U.S. and Europe so that customers can address drug manufacturing needs in either geography.
97% Replica
“The two facilities in Holly Springs and in Denmark are 97% a replica of each other, from a requirement point of view,” Petersen said. “That means we’re one of the very few companies in the world that are actually capable of moving very quickly between two facilities.”
Fujifilm Diosynth Biotechnologies is among CDMOs that are responding to growing demand for outsourced manufacturing and other services driven by larger biopharmas. And the company isn’t the only global CDMO in expansion mode.
In March, Lonza Group signaled its intent to grow in the U.S. by acquiring Genentech’s large-scale biologics manufacturing site in Vacaville, CA, for $1.2 billion from Genentech’s parent Roche. The deal is expected to close in the second half of this year. A seven-hour drive north in Bend, OR, Lonza has expanded its service offering for spray-drying of proteins for pulmonary delivery, providing clinical and commercial manufacturing services at a kilogram scale.
Another Fujifilm Diosynth competitor, WuXi Biologics, has announced expansion projects that include increasing its Worcester, MA facility’s capacity to 36,000L, from an initially planned 24,000L; and installing a new drug product fill-and-finish line at its Leverkusen site and doubling the Wuppertal site’s capacity from 12,000L to 24,000L. In January, the company completed its first manufacturing run at its drug substance facility MFG7 in Dundalk, Ireland, reaching 16,000-liter scale by combining four 4,000-liter single-use bioreactors.
WuXi Biologics and other Chinese biotechs were facing a loss of significant U.S. business had Congress passed, and President Joe Biden had signed into law, the BIOSECURE Act (H.R. 7085), which would forbid the awarding of federal contracts—including procurement of drugs for Medicare and Medicaid—to “foreign adversary biotech companies of U.S. national security concern.” A revised version of the measure introduced last month would have allowed U.S. companies to keep working with WuXi Biologics and other Chinese biotechs named in the bill until 2032.
But the BIOSECURE Act’s future has become unclear after it was not among 350 amendments that the House Rules Committee agreed to consider including in the National Defense Authorization Act being crafted for federal fiscal year 2025, which begins October 1. While months of Congressional debate over BIOSECURE have created uncertainty within the CDMO market, Fujifilm Diosynth says it is among companies capable of answering the concerns of biopharmas.
Supply chain and incentives
“It definitely has an effect on supply chains, and companies all need to make sure they have plans and mitigations for that. There is a huge discussion on supply, and already even before that discussion, there are many patients in the world who don’t have access to medicine, and we’ve just seen that continually grow,” Petersen observed.
“For five years we’ve been at full capacity, basically, since we went into large scale manufacturing. That means that when you additionally have issues like the BIOSECURE Act putting risk, you just additionally on top of already full capacity are asking companies to absorb bigger challenges, which is the dialogue around the BIOSECURE Act: How do we secure access to medicine for patients? And I think we definitely are one of the companies which is well positioned to support that.”
State and local officials contend they will more than recoup what they will spend since the expansion is projected to increase the state gross domestic product by $4.76 billion over 12 years, and because the jobs being created by Fujifilm Diosynth have an average wage of $109,923—about 47% above Wake County’s average annual wage of $74,866.
Wake County agreed to shell out $30.6 million while Holly Springs will spend $23.7 million on local infrastructure improvements. Holly Springs has agreed to dedicate $10 million in future property taxes toward funding transportation projects investments across the town, including a new “southern access” road to be built behind the Fujifilm Diosynth facility to ease congestion on Green Oaks Parkway.
The North Carolina Department of Commerce’s Economic Investment Committee (EIC) approved a 12-year, nearly $15 million ($14,989,500) Job Development Investment Grant (JDIG), with funds to be paid to the company based on tax revenues to be generated by the new jobs. The state insists that its departments of Commerce and Revenue will verify that Fujifilm Diosynth has met incremental job creation and investment targets before paying out grant funds to the company.
Also, the North Carolina Community College System agreed to provide customized job training support totaling $1.7 million, while the state Commerce Department’s Division of Workforce Solutions will contribute $1.3 million toward job support.
Beyond location, location, location
“Just as in real estate, it’s location, location, in economic development it’s talent, talent, talent,” William O. Bullock, MBA, senior vice president, economic development and statewide operations with the state-funded North Carolina Biotechnology Center, told GEN Edge. “If you don’t have the talent, you’re not going to win these projects. A lot of people have land. A lot of people have infrastructure. A lot of people have incentives. We have all that too.”
“What we have is two things, I think, that help us in this space,” Bullock explained in an interview during BIO 2024. One is a culture of collaboration between various public and private entities. The other is the quality and size of North Carolina’s life sciences workforce.
“We have the talent, and we’ve been investing in those talent programs for 20 years, not just in having a lot of good graduates coming out with biology degrees, which we do. These are very targeted programs at the four-year level and at the two-year community college level that focus on bioprocessing and biomanufacturing.”
The state bolstered its biomanufacturing training in 2022, when the North Carolina Biotechnology Center led a statewide coalition of public and private organizations and institutions in winning a nearly $25 million Phase II award through the U.S. Economic Development Administration’s Build Back Better Regional Challenge. The award aimed to advance biomanufacturing by expanding, connecting, and promoting training and career opportunities to underserved and distressed communities.
Bullock said North Carolina has some 37,000 biomanufacturing jobs, accounting for roughly half of the state’s 75,000-person life sciences workforce: “There’s just a huge base that companies like Fujifilm Diosynth can go to find employment.”
That employment base is was one of several key factors in Fujifilm Diosynth expanding in Holly Springs, Petersen said.
“It’s the network, the infrastructure, the support in every regard, the resources, training, sustainability. The infrastructure in general has been absolutely superb,” Petersen said. “There’s no question why companies are choosing North Carolina.
Fujifilm Diosynth’s expansion in Holly Springs was announced in April, hours before Japanese Prime Minister Fumio Kishida began a visit to North Carolina that included stops at facilities for Toyota and HondaJet. In October, North Carolina Gov. Roy Cooper led a state delegation that visited Japan.
Large and small
Under Petersen, Fujifilm Diosynth restructured its operations into separate business units focused on supporting large- and small-scale biopharmaceutical customers. The Small-Scale unit supports clients needing bioreactors ranging from 200 L to 2,000 L as well as single-use manufacturing systems, while Large-Scale unit clients need access to high-volume cell culture production using multiples of 20,000 L bioreactors.
The large-scale business has seen demand grow as biopharma giants have shifted manufacturing from in-house units to CDMOs and stepped up development of Alzheimer’s disease drugs, Petersen said. However, demand from small-scale customers has declined since COVID-19 evolved from pandemic to endemic, as venture capital firms cut down on earlier rounds of funding to startups in favor of larger later rounds to more established private biotechs.
Fujifilm Diosynth cited that decrease in small-scale activity in April, when it carried out a restructuring in which the company eliminated 240 jobs at its sites in College Station, TX; Raleigh, NC; Watertown, MA; and Teesside, U.K.
“I would say the growth in large scale has definitely been higher than the small scale, but we’ve seen a lot of demand on small scale as well,” Petersen said.
Does that mean small scale manufacturing will soon start growing again?
“Yes, we could begin to see that,” Petersen said. “We are filling up what we have. Another question is, you need to have capacity. We have one investment going on right now in small scale, and we are ready to make more investments. But then, you have the time that it takes when that is to come online.”
Cell therapy expansion
Fujifilm Diosynth is also expanding its process development and manufacturing capabilities for cell therapies in the Los Angeles suburb of Thousand Oaks, CA, where the company is adding two new manufacturing clean rooms to its existing three, remodeling its existing GMP facilities, and expanding its warehouse space. The expansion space is expected to be operational next year.
The Thousand Oaks project is one of two cell therapy expansion projects totaling $200 million for parent Fujifilm. The company is also building a new 175,000-square-foot headquarters for its Fujifilm Cellular Dynamics subsidiary in Madison, WI, that is slated for completion in 2026 (Fujifilm acquired CDI in 2015 for $307 million). The new HQ will include expanded process development laboratory and a current GMP (cGMP) facility for cellular therapeutics; construction of three new clean rooms that will join the existing three clean rooms; as well as space for development, production facility and warehousing of cells for drug development support.
The end of June will mark Petersen’s first year as CEO of Fujifilm Diosynth. He took the company’s helm after previously serving as chief operating officer of the Hillerød, Denmark, site and head of its large-scale strategic business unit. Before 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 Fujifilm Diosynth CEO. “It’s quite a transition when you have not had a CEO job before. I’ve been part of the business for now what, five years? I was part of the leadership team, but still CEO still feels like a new job at 11 months in now.”
It’s still too soon to celebrate, he cautions: “The anniversary is still weeks away.”
