Fujifilm Diosynth Biotechnologies is proceeding with a multi-billion-dollar biomanufacturing expansion. Lars Petersen, President & CEO, Fujifilm Diosynth Biotechnologies, provided an update at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

The company is making significant capital investments to expand large-scale cell-culture bulk drug substance and flexible single-use cell culture capacity with the addition of commercial-scale drug product and finished goods capacity. The cell-culture expansions apply the company’s KojoX operational framework, which emphasizes process, equipment, and procedural modules.

The company announced a $1.6-billion capital investment for the expansion of large-scale cell culture capacity in its Denmark facility in 2022. With mechanical completion achieved in January 2024, the first drug-substance expansion is set to come on line later in the same year (2024). The new drug-product facility in Denmark is expected to be operational by early 2025, following a successful filling line test run in February 2024. The second drug-substance expansion is slated for online activation in 2026.

Building on the success of its Danish counterpart, the company is investing $2 billion in its Holly Springs, North Carolina, facility. Applying the KojoX principles throughout the design, operations, training, and supply-chain management, the facility is set to introduce large-scale cell-culture drug-substance suites in 2025. Suite 1, with four 20,000-liter bioreactors, is fully installed while two out of four bioreactors in Suite 2 are already in place. Current milestones include the facility becoming weather-tight in November 2023 on track for timely project completion.

An $850-million capital investment announced in 2021 signaled the company’s intent to establish a flexible cell-culture facility at its Billingham, UK location. A significant project scope change focused on applying modular principles, allowing lanes to mix 2,000-liter and 5,000-liter bioreactors. This design ensures flexibility while future-proofing infrastructure for rapid capacity additions as demand dictates. The facility is set to be operational by 2026.

In late 2023, the company announced a new investment for a cell-therapy expansion at its Thousand Oaks, California, facility. The project includes the creation of two new cleanrooms, with a flexible design to support Grade B/Grade C background classification. The facility is adaptable for various automated equipment platforms, with expansion plans accommodating multiple automated platforms and isolators. The construction timeline indicates foundations and steel completion by mid-April 2024, laboratories by the end of July 2024, and cleanroom construction concluding mid-September 2024. Commissioning and qualification are set to be completed by the end of January 2025.