With several high-profile drugmakers already lining up for manufacturing space, Fujifilm Biotechnologies is on the cusp of kicking off operations at a much-anticipated mega plant in North Carolina. Meanwhile, the company is wasting no time building out additional capacity at the facility, which will function as a parallel to one of the CDMO’s near-identical biomanufacturing plants in Denmark.

After telegraphing plans to build a $2 billion end-to-end cell culture production facility in Holly Springs, North Carolina, in 2021, Fujifilm Biotechnologies will commence commercial operations under the first phase of the site’s buildout later this year, representatives for the company said during a recent site tour attended by Fierce Pharma.

Fujifilm has said that the facility will, in part, help the CDMO tap the full potential of the antibody drug market, including that for antibody-drug conjugates (ADCs) and bispecifics.

Initial operations at Holly Springs will rely upon eight 20,000-liter bioreactors and focus exclusively on drug substance manufacturing before drug product capabilities come online in 2026 and finished drug production shortly after that, Laurie Braxton, SVP and head of North Carolina operations at Fujifilm Biotechnologies, said during the facility visit. 

Still, expecting big things from the facility, Fujifilm last April plugged $1.2 billion more into the up-and-coming Holly Springs site to increase the cell culture facility’s footprint by more than 400,000 square feet and add a total of eight new 20,000-liter mammalian cell culture bioreactors for bulk drug substance. 

Once both phases of the project are complete, the site will boast a total of 16 bioreactors, each with 20,000 liters of capacity.

Beyond the pre-opening drug substance expansion, Fujifilm Biotechnologies continues to eye growth opportunities at the site, with Braxton noting that the CDMO could extend its drug product capabilities, as well, once commercial operations have kicked off and it’s easier to gauge customer demand.

The facility is situated on 150 acres of land, just 90 of which have been developed so far, Braxton pointed out.

The site currently employs more than 500 people and aims to reach a headcount of 700 by the end of the year, Braxton said. The total planned workforce in Holly Springs will reach around 1,400 by 2031. As with other life sciences companies that have established manufacturing roots in North Carolina, Fujifilm is leveraging talent from nearby institutions like North Carolina State University’s Biomanufacturing Training and Education Center, and roughly 80% of the plant’s current workforce is local, she added.

Fujifilm Biotechnologies has designed the facility “like-for-like” with a companion plant in Hillerød, Denmark, under the company’s Japanese-influenced KojoX philosophy, Braxton explained.

In Japanese, Kojo can be defined as both “improvement” and “factory,” which Fujifilm has sought to internalize in its design of modular and adaptable bioproduction sites like those in North Carolina and Denmark.

At Holly Springs, the CDMO has been able to apply learnings from growth projects at the Danish site, which was purchased from Biogen in 2019 and is set to wrap up a major capacity expansion in 2026, Braxton noted.

By incorporating designs from the Denmark facility in North Carolina, Fujifilm Biotechnologies aims to ease the contract manufacturing process for drugmakers operating on both sides of the pond. The sites have the potential for dual tech transfers and there is a chance drugs produced at the sites could receive speedier regulatory approvals thanks to the comparability of the production operations at Fujifilm’s KojoX facilities, Braxton said.

“Whether here or in Denmark, once you get into production, the setup and experience [are] the same,” she explained.

As Fujifilm Biotechnologies preps its Holly Springs plant for its debut, multiple big-name drugmakers have already booked production slots at the facility.

In November 2023, Johnson & Johnson’s Janssen Supply Group locked in a deal for a large-scale manufacturing suite, which will be used to support both clinical and commercial-stage projects.

More recently, Regeneron in April inked a $3 billion, 10-year agreement with Fujifilm Biotechnologies, enlisting the CDMO to chip in on the manufacturing of bulk drug product for Regeneron’s commercial biologics at the Holly Springs site.

While production work won’t start until the plant formally opens for business later this year, the technology transfer for the deal was said to be “beginning immediately” when Regeneron announced the tie-up in the spring.

Following a spate of manufacturing investments in North Carolina, Denmark and beyond in recent years, Fujifilm Biotechnologies—which recently simplified its brand from Fujifilm Diosynth Biotechnologies—expects 2025 to be its “biggest year” yet with regards to production expansion progress, the CDMO’s chief executive, Lars Petersen, said in an interview earlier this year.

Fujifilm has laid out more than $8 billion in manufacturing investments since 2011, the CEO noted. By August or September of this year, Petersen said he expects “basically half” of those investment projects to be “in operation,” placing a particular emphasis on the Holly Springs site.