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Manufacture Facilities, Advanced Medicine, Contract Manufacturing Services, Business Practice

FUJIFILM Diosynth and Regeneron Sign 10-Year, $3 Billion Manufacturing Agreement

Credit: FUJIFILM Diosynth Biotechnologies' Holly Springs, N.C. campus

FUJIFILM Diosynth Biotechnologies and Regeneron Pharmaceuticals have signed a 10-year manufacturing agreement valued at more than $3 billion. Under the agreement, FUJIFILM Diosynth will manufacture commercial and clinical biologics for Regeneron at its new facility in Holly Springs, North Carolina.

The Holly Springs site, expected to be operational later in 2025, is part of the company’s global kojoX manufacturing network, designed to standardize processes and equipment across facilities, with the aim of enabling efficient technology transfers and supply chain continuity.

The agreement will support large-scale drug substance manufacturing for Regeneron’s biologic medicines. According to the companies, the arrangement is intended to address current and future manufacturing needs related to Regeneron’s commercial portfolio and pipeline.

No specific products or volumes were disclosed as part of the announcement. The companies also did not disclose financial details beyond the total value of the agreement.

In a statement, Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division at FUJIFILM in Japan said: “As the U.S. is the largest market for biopharmaceuticals, FUJIFILM Corporation has made significant investments in the U.S. of about $4 billion in building world-class biopharmaceutical manufacturing sites, life sciences capabilities, and growing its technical talent. Additionally, through our previously announced expansion efforts, we are pleased to share that we’ve already added 500 new positions as part of our overall goal of creating 1,400 new jobs in North Carolina by 2031.”

The facility in Holly Springs will feature single-use bioreactor technology and is designed to support large-scale, late-stage, and commercial production. The companies stated that the site will also incorporate capabilities for continuous manufacturing.

The agreement follows a broader trend of long-term outsourcing partnerships in the biopharmaceutical industry, particularly for large-scale biologics manufacturing. Both companies indicated that the collaboration is focused on meeting projected global demand and reinforcing US-based manufacturing capacity.

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