Excitement around Fujifilm Biotechnologies’ massive new cell culture facility in Holly Springs, North Carolina, has been growing steadily since 2021, prompting a beefed-up investment from the company last April and a string of high-profile manufacturing contracts this year.
Now, some four years since the project’s reveal, Fujifilm Biotechnologies is opening the doors to the facility, which might look familiar to anyone who’s worked with the CDMO in Denmark.
The opening of the Holly Springs site, which will focus on antibody-based drugs, marks the debut of one of the largest cell culture biomanufacturing sites in the U.S., Fujifilm Biotechnologies said in a Sept. 24 press release.
The $3.2 billion commercial plant is kicking things off with eight 20,000-liter bioreactors capable of tackling both drug substance and drug product production. The company plans to bring finished goods capabilities online in 2026 and announced last year that it aims to double the plant’s capacity with another eight bioreactors by 2028.
The facility is opening with a workforce of more than 680 employees, Fujifilm Biotechnologies noted in its release. The company says it’s on track to raise its Holly Springs headcount to 750 by the end of the year and ultimately aims to employ a total of 1,400 workers at the site by 2031. Fujifilm Biotechnologies currently employs around 5,000 people around the world.
Fujifilm Biotechnologies is the CDMO subsidiary of Fujifilm Corporation’s life sciences division. The manufacturer, which simplified its brand from Fujifilm Diosynth Biotechnologies earlier this year, was formed when Fujifilm acquired Merck & Co.’s CDMO unit in 2011.
The CDMO asserts that it was able to reduce the design time of the Holly Springs site by about 70%, thanks in no small part to the fact that the new facility is a “near-replica” of Fujifilm Biotechnologies’ commercial-scale site in Hillerød, Denmark.
When Fujifilm Biotechnologies drafted plans for the North Carolina facility in late 2020, the company was driven by demand at the doppelganger plant in Denmark and the strategic value of the U.S. market in general, Lars Petersen, CEO of Fujifilm Biotechnologies, said in a recent interview with Fierce Pharma.
The company's leadership in Japan "always had a thinking that the U.S. is a very important market,” he explained. “We need to have a facility there.”
Both the Denmark plant and its Holly Springs twin were created out of Fujifilm Biotechnologies’ desire to approach the CDMO space “in a new way,” which included “cloning” its Denmark plant in North Carolina under the company’s “KojoX” design philosophy, Petersen said.
Under the KojoX framework, Fujifilm is striving to establish “harmonized design” across its production network.
One could say that the company is simply taking the same equipment and facility layout from one plant and copying it onto another location—and they wouldn’t be wrong—but the focus of the strategy, to hear Petersen tell it, is the flexibility and consistency that this approach can provide for drugmakers operating in multiple parts of the world.
The plant-cloning approach was a good fit for the North Carolina facility, which has been designed as a “pure antibody site,” because that modality is mature and its manufacturing process is both well understood and easy to industrialize, Petersen said.
Nevertheless, Fujifilm Biotechnologies will continue to explore opportunities to test the “KojoX” strategy across its operations. In fact, the CDMO is already doing just that—albeit at a “different scale”—with a smaller antibody facility in the U.K. that’s expected to open next year and a twin factory in Toyama, Japan, that’s slated to kick off operations in 2027, Petersen said.
Fujifilm Biotechnologies is confident in the scale of the Holly Springs facility and is adopting a wait-and-see approach on any further expansion plans based on timing and demand, Petersen explained.
Still, space remains available to “take the entire phase 1 and 2 and replicate one more time” at Holly Springs, he said.
Designs on the Holly Springs facility predated the Trump administration’s renewed push for domestic pharmaceutical manufacturing in the U.S.—and the tariff threats that have accompanied that agenda—but Fujifilm’s new plant has benefited all the same, Petersen noted.
“Demand and ask for U.S. capacity is very hot,” he said. “We’ve seen an uptick and interest in making decisions quick since a new administration came onboard.”
Dealmaking streak
Fujifilm Biotechnologies has already booked a trio of high-profile contracts at the site.
Back in April, Regeneron kicked things off with a 10-year, $3 billion agreement with Fujifilm Biotechnologies to help manufacture bulk drug product for its commercial medicines at the Holly Springs site. A few months later, J&J laid out $2 billion in another decade-long manufacturing deal centered on Holly Springs.
Meanwhile, argenx earlier this month became the third notable client at the new site, striking a deal that will see Fujifilm Biotechnologies help produce its autoimmune blockbuster Vyvgart in North Carolina when the phase 2 plant expansion comes online in 2028. Fujifilm Biotechnologies is already producing drug substance for the argenx product at its twin facility in Hillerød.
Back in January, Petersen said 2025 would mark an inflection point for Fujifilm Biotechnologies, and he continues to hold that belief nearly eight months later.
“This is a big year,” he said. “We opened up the expansion in Denmark end of last year—it’s fully running now. Now, we’re opening our U.S. facility, our flagship, here in the U.S., so this year has been a big mark for Fujifilm.”
“I would have thought it would have taken longer,” he added, referring to the interest generated by the Holly Springs site, “but clearly, the J&J and the Regeneron deal have put us on the map, so everybody knows who we are.”