FUJIFILM signs $3B deal with Regeneron for biologics work in Holly Springs

FUJIFILM Diosynth Biotechnologies, a global contract development and manufacturing organization (CDMO) with major operations in North Carolina, has signed an agreement valued at over $3 billion to produce biologic medicines for Regeneron Pharmaceuticals.

Under the terms of the 10-year agreement, FUJIFILM Diosynth Biotechnologies will provide U.S.-based manufacturing for Regeneron through current and planned expansions at its new biopharmaceutical production facility in Holly Springs, N.C., when the site begins operations later this year.Regeneron logo

“This agreement with an industry-leading biologic medicines company demonstrates that FUJIFILM Diosynth Biotechnologies is trusted by our partners to deliver through our technical expertise, talented team and operational readiness,” said Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division of FUJIFILM Corp.

Regeneron, already one of the world’s largest manufacturers of biologics, will nearly double its U.S. large-scale manufacturing capacity by accessing FUJIFILM Diosynth Biotechnologies' facility in Holly Springs. 

“At Regeneron, we have the privilege of making some of the best and most innovative therapeutics in the industry, and we are acutely aware of Regeneron’s impact on people’s lives as we work to help treat or even cure devastating diseases,” said Daniel Van Plew, executive vice president and general manager, industrial operations and product supply at Regeneron. “We take our role seriously, and our decision to work with FUJIFILM Diosynth Biotechnologies reflects our belief that they will meet our high standards and grow with us. We are excited about this unique relationship, and we are already working to bring capacity online at FUJIFILM Diosynth Biotechnologies’ biologics manufacturing facility in Holly Springs.”  

Expanding footprint in N.C.

FUJIFILM Diosynth Biotechnologies, which produces biologics, vaccines and advanced therapies for biopharmaceutical companies under contract, operates a multi-product manufacturing facility in Research Triangle Park, N.C., that performs fermentation, cell culture, recovery, purification, and bulk fill. The site is also home to the company’s Bioprocess Innovation Center and related administrative functions.

FUJIFILM logoFUJIFILM Diosynth Biotechnologies is building the company’s largest end-to-end cell culture biopharmaceutical CDMO facility in North America in Holly Springs. The facility will offer large-scale cell culture manufacturing of bulk drug substance using eight 20,000-liter bioreactors.

While construction was underway in April 2024, the company announced a $1.2 billion expansion of the facility, bringing the total investment in Holly Springs to over $3.2 billion. The expansion will add eight 20,000-liter mammalian cell culture bioreactors by 2028.

The investments are expected to grow FUJIFILM’s workforce in Holly Springs to 1,400 by 2031, the company said.

The Holly Springs expansion is part of the company’s $7 billion expansion projects underway in the U.S. and Europe. In total, the company employs about 4,800 people, mostly at major facilities in the U.S., the United Kingdom and Denmark.

The Holly Springs site is part of FUJIFILM Diosynth Biotechnologies' kojoX interconnected manufacturing network, “which provides a first-of-its-kind modular approach with standardized equipment, processes and procedures across our sites around the globe to help ensure supply chain security and seamless tech transfers,” said Lars Petersen, president and chief executive officer of FUJIFILM Diosynth Biotechnologies. “Partnering with Regeneron, a global leader in biotechnology and scientific innovation, is a true honor for us, as we bring together our exceptional teams and shared vision to make transformative medicine accessible to patients. We are honored that Regeneron has the trust and confidence in our teams’ ability to help deliver capacity faster, ensuring continuity of supply for patients in need.”

With over 30 years of experience, FUJIFILM Diosynth Biotechnologies specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian and host/virus systems.

FUJIFILM Holdings Corp., the parent company of FUJIFILM Corp. and FUJIFILM Diosynth Biotechnologies, is a multinational company based in Tokyo.  The company employs over 70,000 people worldwide in four key businesses: healthcare, electronics, business innovation and imaging.

Fujifilm has 23 subsidiaries in the Americas with a cumulative revenue of about $4.3 billion and over 7,800 employees.

Regeneron growing

Regeneron Pharmaceuticals, based in Tarrytown, N.Y., is expanding its own capacities for drug development and production. In the last five years, the company has added more than 7,000 jobs, mostly in the United States. 

A $3.6 billion expansion of Regeneron’s Tarrytown campus is underway, creating 1,000 full-time, high-skill jobs and expanding research, preclinical manufacturing and support facilities. In addition, the company is constructing a new, state-of-the-art fill/finish manufacturing facility in Rensselaer, N.Y., and has acquired an over 1 million-square-foot property in Saratoga Springs, N.Y., for production support activities and, potentially, additional manufacturing capacity.

The company has medicines or medicines in development to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases and rare diseases.

“Regeneron is an American success story, with over 80 percent of our workforce and assets in the U.S.,” said Leonard Schleifer, M.D., Ph.D., board co-chair, president and chief executive officer of Regeneron. “Our innovative approach has filled our commercial and clinical pipeline with important new medicines and driven a need for even more manufacturing capacity to fulfill the promise of our science. We are meeting this need through increased investment in New York and North Carolina.”

Barry Teater, NCBiotech Writer
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