A rendering of the $2 billion cell culture manufacturing facility for which Fujifilm Diosynth Biotechnologies broke ground last week in Holly Springs, NC. [Fujifilm Diosynth Biotechnologies]
The cell culture manufacturing facility for which Fujifilm Diosynth Biotechnologies broke ground last week in Holly Springs, NC, will cost at least $2 billion to build, and possibly more depending on how many bioreactors are ultimately built there.

The facility is designed for large-scale cell culture manufacturing of bulk drug substance production with eight 20,000L bioreactors. But the facility could be expanded to accommodate up to 24 more 20,000L bioreactors based on market demand, for a potential total of 32, Fujifilm Diosynth Biotechnologies CEO Martin Meeson told GEN Edge.

“There will be an additional spend to the $2 billion. I’m hoping it’s not two times four,” Meeson said, as in a quadrupling of the cost equal to quadrupling the number of bioreactors. “Obviously there will be some efficiencies as we go forward and continue to build out. I’m going to definitely be challenging my team to build some of those efficiencies in there.”

Efficiencies are expected, he said, because of Fujifilm Diosynth’s experience in expanding cell culture facilities elsewhere—specifically Hillerød, Denmark, where the company is constructing a ¥100 billion ($875 million) cell culture expansion project that began in March.

Fujifilm Diosynth Biotechnologies reasons it can better serve biopharma clients by creating an additional cell culture facility within 150 acres in Holly Springs, NC, a 25-minute car-ride south of Research Triangle Park (RTP) and the company’s existing campus in the Tar Heel State. Fujifilm Diosynth—the biologics contract development and manufacturing organization (CDMO) subsidiary of Fujifilm—will operate the new manufacturing site, which it says will be the largest facility of its kind in North America.

“There will be a very, very high degree of similarity [between Denmark and Holly Springs], not just in the bioreactors. It’s in the way that that process is set up, and the way we go about making these medicines in a very, very efficient and a very standard format,” Meeson said. “We really been able to work with our partners together, a very, very standard way of working with the new modules–some of the new modules we’re building in Denmark, and we’ve carried that across into the work we’re doing at the site in Holly Springs.”

“A Good challenge”

“It’s been a good challenge. The engineering team has really responded to building in those efficiency benefits,” Meeson added. “And that gives us the ability then to very easily be able to move client projects around should they require it from a demand point of view, or even from a from a regional point of view.”

Construction is proceeding apace in Hillerød, Meeson said, with workers recently completing roof and other exterior work, including the last piece of structural steel, and marking the “sealing” of the building with a little ceremony. The company said it will add 300 jobs by the end of 2023 at the site, which Fujifilm acquired for approximately $890 million in 2019.

In Holly Springs, Fujifilm Diosynth Biotechnologies projects it will begin operations in spring 2025, and generate 725 new jobs by the end of 2028. Approximately 50 of those jobs have already been filled.

“These are people–you might use the word facilities, but they’re logistics, they’re manufacturing, they’re automation people,” Meeson said. We know how to go about making this a successful project, and it’s getting people in there, not just people who know how to build things, but how to operate things.”

Those hires, he added, were needed to help Fujifilm Diosynth Biotechnologies fulfill its goal of building a sustainable facility targeting 100% clean energy use, plus waste disposal and recycling consistent with its goal. The Holly Springs facility is being developed to align with parent Fujifilm’s Sustainable Value Plan 2030the company’s Environmental, Social, and Governance (ESG) plan articulating goals the company has committed to achieving by the end of 2030, the third quarter of Fujifilm’s 2031 fiscal year.

Holly Springs and Hillerød, Denmark, are two of four sites where Fujifilm Diosynth Biotechnologies has been carrying out expansions:

  • In the Boston suburb of Watertown, MA, the company joined MIT, Harvard University, Cytiva, and Alexandria Real Estate Equities in breaking ground in August on Landmark Bio (formerly the Center for Advanced Biological Innovation and Manufacturing), a $50 million, 40,000-square-foot  biopharma manufacturing facility designed to advance cell and gene therapy, gene editing, and mRNA products. The facility is set to open in 2022.
  • In College Station, TX, the company has tripled its advanced therapies process development capabilities by completing a $55 million Advanced Therapies Innovation Center that houses dedicated process development and innovation laboratories with BSL-2 capabilities and upstream, downstream, and analytical development technologies. The facility added 100 jobs to the company’s College Station workforce.

Fujifilm Diosynth Biotechnologies isn’t the only CDMO in expansion mode. In recent years, Catalent, Lonza, Patheon by Thermo Fisher Scientific, and Recipharm have grown by building new facilities as well as through mergers and acquisitions.

Carolina calling

College Station and Holly Springs emerged as Fujifilm Diosynth Biotechnologies’ short list of top choices for locating the U.S. cell culture facility. The North Carolina site won out despite Texas officials assembling a larger package of economic development incentives for College Station that according to the Austin Business Journal totaled $300 million.

The city of Holly Springs and Wake County, NC, combined to deliver up-to-$90 million in economic incentives, while officials in North Carolina assembled some $33 million in economic incentives—the state’s largest sum awarded to a life sciences company.

The largest component of state funding was a Job Development Investment Grant of more than $19.7 million spread over 12 years, with Fujifilm Diosynth Biotechnologies required in return to invest $1.5 billion in capital in the new facility and meet incremental hiring targets.

North Carolina also awarded the company a $2 million grant through its One North Carolina Fund, a discretionary cash-grant program through which the Governor’s Office can quickly fund job-creation projects for which the state is competing with other states; as well as funds toward job training and road improvements.

Meeson said the state and local economic incentives will be more than recouped by the $5.5 billion in direct and indirect economic impact the Holly Springs cell culture facility is projected to generate over the next 12 years, such as increased local hiring, which he said has already begun.

Over those 12 years, new state tax revenues generated by the new jobs will exceed $160 million, according to the office of Gov. Roy Cooper (R). He joined executives from Fujifilm Diosynth Biotechnologies and dignitaries from Holly Springs, Wake County and state governments in a groundbreaking ceremony for the cell culture facility, held October 14 under sunny skies.

Sense beyond dollars

Meeson said Fujifilm’s decision to build its cell culture facility in Holly Springs made sense for reasons beyond incentive dollars. Holly Springs is near RTP, which along with the cities of Raleigh and Durham have grown over the past half-century into a regional cluster ranked ninth by GEN in its updated A-List of “Top 10 U.S. Biopharma Clusters,” published March 10.

Many of the region’s life sciences attractions and expansions have been gene and cell therapy facilities by Astellas Gene Therapies (formerly Audentes Therapeutics, Sanford, NC), Bluebird Bio (Durham), Novartis (formerly AveXis; RTP), and Pfizer (Sanford). The region also has manufacturing sites planned by Eli Lilly (pharmaceuticals, RTP), Grifols (blood plasma, Clayton, NC); and an expanded HQ/”innovation” space by single cell genome sequencing company BioSkryb Genetics (Durham).

At RTP, Fujifilm Diosynth Biotechnologies already bases about 800 jobs (Morrisville, NC, address) at its largest of four facilities worldwide. The company opened its RTP site in 1996, on a campus that has since expanded to include three buildings that house the company’s Process Development and Analytical Laboratories, cGMP Manufacturing Facility, and Administration.

Some Morrisville-based jobs will be shifted from RTP, and across the company’s other sites, to Holly Springs, Meeson said: “That’s one of the advantages of an organization like ourselves: It’s got such a broad level of experience. We’re able to move that experience around to benefit all of the projects that we work on.”

In Holly Springs, Meeson said, Fujifilm Diosynth Biotechnologies found a city that, along with Wake County and the state, had been purposeful in supporting the biotechnology industry by addressing environmental and social issues as well as workforce and land-use needs.

“When I say ‘purposeful,’ I think about not just the talent that they’ve got there, but also the way they went about focusing on delivering the project from a ‘build’ point of view, and how they have very long-term aspirations to work with us,” Meeson said. “It was not just about building something. It was about “How do we help you run this? How do we help you integrate and engage in the community? How do we make this a success over all the elements of the project that you are looking at? And that was something we were very impressed with right from the start.”

Holly Springs’ Strategic Plan, which lays out goals and development priorities, commits the city to “support land use planning and policies that provide for sustainable and economic growth while balancing small town characteristics.” The city has also developed a reclaimed water system designed to facilitate sustainable industrial growth, and has identified life sciences and biomanufacturing as a key industry for attraction.

Biopharma strengths

Among Holly Springs’ biopharma strengths is the presence of a cell culture-based influenza vaccine developer, Seqirus, a wholly-owned subsidiary of CSL. The company operates a 185-acre, $1 billion+ plant built by Novartis in 2014 with the U.S. Biomedical Advanced Research and Development Authority to help combat pandemic threats. A year later, CSL bought Novartis’ influenza vaccine business for $275 million and acquired the facility as a result.

“The city, county and state have done a really good job in making sure that there is available talent. It’s obviously one of the key things that we need. And the development here in North Carolina is extremely strong,” Meeson said.

He cited the state-funded North Carolina Biotechnology Center, created in 1984 to advance the industry statewide and wean the state’s economy from the declining tobacco, textiles, and furniture sectors.

“You’ve got the universities, the community college and network, all of which we use today and will continue to use them going forward,” That’s what’s more important when you’re doing these things,” Meeson added

Fujifilm Diosynth Biotechnologies has developed relationships with numerous regional academic institutions, from Wake Technical Community College and the rest of the 58-school North Carolina Community College System to NC State, UNC-Chapel Hill, Duke University, and North Carolina Central University.

Wake Tech is leading training of new employees at Holly Springs, and has offered temporary space at its Morrisville campus to help conduct hiring and training, while NC State will provide customized workforce training at its Biomanufacturing Training and Education Center.

Meeson said no new workforce development programs were created with schools as a result of Holly Springs.

“What there will be is some increased volume [of trainees], and we know we have a commitment from the state to make sure that they continue to invest and make this available,” Meeson said, “not just for us but the other life science companies that they have attracted and are already operating here.”