Fujifilm Biotechnologies’ Holly Springs, North Carolina site is a clone of Danish facility
Building identical large-scale biomanufacturing facilities on two different continents is no small feat. However, that’s the goal of Fujifilm Biotechnologies — formerly Fujifilm Diosynth Biotechnologies — as it looks to begin operations later this year at its new facility in Holly Springs, North Carolina, a booming bedroom community about 20 miles from Raleigh.
As a global contract development and manufacturing organization (CDMO), Fujifilm Biotechnologies has embraced a modular model called KojoX, a harmonized design of facilities, equipment, processes, and quality systems to ensure that customers can seamlessly integrate manufacturing regardless of location.
“We have a cloning strategy with a modular design,” said Laurie Braxton, senior vice president and head of North Carolina operations at Fujifilm Biotechnologies. “We’re building them like for like — that means in the construction, in the equipment we’re using, the policies, the procedures, and the operations.”
According to Braxton, Fujifilm is not the first company to try to design, build, and operate its manufacturing sites in the same manner but others have ultimately failed. “It’s been attempted,” she said. “It takes a lot to not only build to a standard, but to hold to it.” At Fujifilm, Braxton contends that KojoX is core to the CDMO’s values and philosophy. “Holding to it is something that we will do and will be a differentiator.”
The first KojoX node in Fujifilm’s network was built in Hillerød, Denmark, home to a large-scale facility that has been in operation for several years and is the sister site to Holly Springs. In November 2024, Fujifilm announced the completion of the first phase of its expansion at Hillerød including six mammalian cell bioreactors, bringing the total capacity at the site to twelve 20,000L bioreactors. The CDMO is leveraging Hillerød’s proven track record of success and replicating the model in Holly Springs, according to Braxton.
“We know what we’re building works — we’re not building a complete greenfield facility from the ground up without a blueprint to work off,” Braxton said. “Denmark did an expansion on to their existing facility that came online at the end of last year. We like to say that we’ve been able to learn from all their bumps and bruises along the way.”
Fujifilm is investing $3.2 billion in the Holly Springs site including the installation of eight 20,000L bioreactors for bulk drug substances, as part of its initial investment which begins operations later this year, as well as an additional second phase of eight 20,000L mammalian-cell culture bioreactors by 2028.
When it is fully operational, Fujifilm claims the Holly Springs site will be one of the largest cell culture biopharma CDMO facilities in North America, employing a workforce of approximately 1,400 people. So far, it has added more than 500 full-time employees.
Growing its capacity
Initially, Fujifilm only planned for a first phase at Holly Springs — drug substances, drug products, and finished goods — and “quickly after we got started, we announced a second phase and started building on further drug substance,” Braxton said.
In early 2026, Fujifilm will bring drug products online, starting with one line that has a capacity to make about 35 million units a year.
“We have the ability to expand in that area, but we want to see what clients we bring in and what they need,” Braxton said. “When you do drug product and filling, you can do vials, syringes, and cartridges — each company has their own preference, so we’d rather build what’s needed versus what we think may be needed. Once we start to produce in drug products, finished goods will then also come online.”
In April, Fujifilm announced a 10-year manufacturing supply agreement worth more than $3 billion with Regeneron Pharmaceuticals to produce the biotechnology company’s biologic medicines. Under the terms of the agreement, the CDMO will provide production services to Regeneron through current and planned expansions at the Holly Springs site.
“We’re continuing year over year to bring on capacity across the two facilities,” Braxton said. “We send teams back and forth between the two to learn, train, and support with expertise if needed. By having that phasing, it allows us to do that in a really smart way.”
The next phase of the Hillerød site’s expansion continues in 2026, which will include an additional eight 20,000L bioreactors, two downstream processing streams, and full fill-finish production.
“What it will do for customers is they will have capacity in the U.S, and Europe, depending on what they need, and to do it in a very streamlined way,” according to Braxton. “We could do dual tech transfers, where we stand up both facilities at the same time. You can fast track regulatory approvals by being able to use the same comparability between the facilities. All of that are conversations we are having with clients to make it cheaper, faster, and with a standard quality they can trust, regardless of where they are.”
Fujifilm’s Holly Springs site encompasses 150 acres, of which 90 acres have been developed, “so we have 60 acres left that we can still do some work on,” Braxton said, noting that the new facility will have the flexibility to expand beyond the planned total of sixteen 20,000L bioreactors with drug product and finished good capabilities.
