Building a Global Network to Increase Speed and Reliable Supply of Biopharmaceuticals

As global demand for life-saving medicines continues to rise, FUJIFILM Diosynth Biotechnologies (FDB) is expanding its biomanufacturing network to boost production capacity and accelerate delivery, ensuring a reliable supply of essential therapies worldwide.

To advance biomanufacturing, FDB is building an interconnected network of sites across key locations in the US, Europe, and Japan. A major milestone was recently reached at our Denmark site in
November 2024 where we double the current capability from 6 x 20,000L to 12. This expansion is just the beginning, with additional capacity coming online in the coming years.

These developments reinforce FDB’s commitment to creating a unified, global manufacturing network that enhances speed and resilience, providing critical support for our customers’ pipelines. Backed by decades of experience and a proven track record in process development (PD), clinical, and commercial production, FDB continues to build on this strong foundation as we expand our global capabilities.

Transforming Biomanufacturing with kojoX™: Replicating Modular Design across Geographies

FDB’s global network of facilities is designed to support customers throughout the entire product life cycle, we call this ‘Partners for Life’. The global, flexible, and scalable network supports products at every stage of development, from preclinical trials through to commercial production, ensuring that manufacturers can quickly adapt to changing market demands. Our customers can enter the value chain at any stage, leveraging modular solutions tailored to their specific needs. With facilities and equipment designed for fast adaptability, FDB can scale manufacturing operations in response to both product and market requirements— whether by increasing capacity or shifting production strategies.

At the core of the ‘Partner for Life strategy’ is the creation of a global, modular network of interconnected manufacturing assets that spans multiple locations, scales, and modalities. kojoX™ harmonizes facility designs, equipment, processes, and procedures to support the rapid development and manufacturing of life-saving therapies.

Flexible, Scalable Manufacturing: kojoX™ in Action

One of the standout examples of the kojoX philosophy is FDB’s leading single-use cell culture facility in Billingham, UK. This site is a part of the global kojoX network and demonstrates FDB’s commitment to flexibility and scalability in biomanufacturing. The facility’s 10,000 m² expansion, with first engineering batch planned for 2025, will increase FDB’s mammalian cell culture production capabilities. This expansion will support a range of cell culture-based products, including monoclonal antibodies (mAbs) and, in the future, viral gene therapies.

The design of the Billingham facility has flexible “lanes” that can be adapted to different product needs and process requirements. Each lane will feature single-use bioreactors in 2,000 L and 5,000 L configurations, with a closed process operation that enables easy scale-out and scale-up.

This modular design ensures that the facility can quickly adapt to the needs of clients, allowing for efficient tech transfers and reducing time-to-market. Moreover, the network’s single-use technology allows for multiplexed scale-up and scale-out strategies that enable programs to be supported across the entire network, from clinical trials to commercialization, without requiring additional technology transfers
between sites.

We are replicating the Billingham facility to both our site in Texas and in Toyama, Japan.

Expanding Capacity Across the Globe

As mentioned, FDB’s kojoX philosophy extends beyond the UK. Our facilities in Denmark and the U.S. are rapidly expanding to support both late phase clinical and commercial production. Ultimately, the total capacity in Hillerød, Denmark will reach 400,000L and the upcoming site in Holly Springs, North Carolina, will feature replicated designs with large-scale stainless-steel bioreactors (up to 20,000L) for commercial production. These sites will be fully integrated with the network’s flexible single use systems, enabling efficient and cost-effective production scaling.

A Future-Proof Network for Rapid Manufacturing

FDB’s commitment to bringing safe and efficacious medicines to the world as fast as possible, combined with our 30+ years of expertise in drug substance development and manufacturing, positions us as a leader in the biopharmaceutical space.

The kojoX model and the global network approach represents the future of biomanufacturing. As FDB expands its network and continues to roll out new facilities and technologies, it will help drive the next generation of life-changing medicines, ensuring that they reach patients who need them most. With a vision that spans the entire product life cycle, FDB is transforming the biomanufacturing landscape for the better.

Learn more about kojoX and contact us if you would like to discuss with our team.