2026 ISPE Facility of the Year Awards (FOYA) Honorable Mention

FUJIFILM Biotechnologies

Location: Holly Springs, North Carolina, USA
Project: Galaxy Project

FUJIFILM Biotechnologies invested in a large-scale, next-generation biologics manufacturing facility in Holly Springs, North Carolina, designed to be North America’s largest end-to-end call culture manufacturing sites across two phases. The campus was designed to enable rapid, scalable, and resilient supply of monoclonal antibody therapies for global markets. The project is recognized as an honorable mention for its innovative application of modular replication, digital delivery, and advanced safety practices in large-scale biomanufacturing.

Innovation is driven by FUJIFILM Biotechnologies’ proprietary kojoX™ modular replication strategy, which standardizes facility layouts, equipment, and processes to support a “design once, build many” approach. Through digital replication, proprietary design tools, and the use of digital twins, the project achieved high first-pass design accuracy and significantly reduced engineering effort, supplier design time, and execution risk across replicated facilities. This approach demonstrates how digital standardization can accelerate delivery while maintaining quality and compliance in complex biologics manufacturing environments.

The facility includes two drug substance manufacturing buildings, each equipped with four 20,000-liter bioreactors and standardized upstream and downstream process platforms. Advanced execution technologies—such as 4D construction simulation, AI-driven progress tracking, drone-based site monitoring, and robotic layout systems—were applied to improve predictability, coordination, and scalability of operations, aligning the site with Pharma 4.0™ principles.

Safety was a core element of project delivery. More than 13 million work hours were completed with an exceptional safety record, supported by Prevention-through-Design methodologies, modularization, and extensive offsite fabrication. These measures significantly reduced high-risk construction activities and were reinforced by virtual reality-based safety training, strong site governance, and an integrated on-site medical capability.

The project incorporates comprehensive sustainability measures and is targeting LEED Gold certification. Key initiatives include water reuse strategies, high-efficiency utility systems, ultra-low NOx boilers, on-site renewable energy generation, and biodiversity restoration. Together, these measures significantly reduced water consumption and carbon emissions compared to conventional large-scale manufacturing facilities.

The successful delivery of the Holly Springs project was enabled through close collaboration between FUJIFILM Biotechnologies and its key partners, including:

Jacobs, an engineering, procurement, and construction management partner, responsible for program management, engineering, and construction delivery
Strategic trade partners and equipment suppliers supporting modular fabrication, automation, and digital execution
Local and regional contractors contributing to construction, commissioning, and site development

This integrated partnership model was essential to achieving the project’s scale, speed, and safety performance.

The FUJIFILM Biotechnologies Holly Springs project represents a strong example of innovation in large-scale biologics manufacturing. Its application of modular replication, digital delivery, and strong safety culture merits a 2026 ISPE FOYA Honorable Mention recognition.