Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, announced the completion of an expansion of its cell-therapy manufacturing facility in Thousand Oaks, California. The event also celebrated the recent European Medicines Agency (EMA) site issuance of a Certificate of GMP Compliance of a Manufacturer.

This expansion upgrades the development labs and adds two new independent cell therapy production suites, significantly increasing cleanroom capacity for new client programs. The cGMP suites are equipped with innovative solutions such as automated cell separation, selection, and expansion equipment, robust and in-built decontamination for rapid changeovers, and HVAC systems that can support either Grade B or C backgrounds which enhances the flexibility needed to support new modalities and meet evolving regulatory expectations. The new suites can accommodate open or closed processing and are large enough to support multiple patients' lots for autologous programs or larger volume batches for allogeneic programs for clinical and commercial clients.

Cell therapy is a transformative approach to treating a wide range of diseases, offering hope to patients through improved quality of life. The global cell therapy market size was estimated at USD 4.8 billion in 2023. As investment in research and clinical trials is intensified and the approval pipeline continues to grow, there is significant traction for cell therapies manufacturing in 2024 and beyond, with predictions suggesting the market will continue to expand at a compound annual growth rate (CAGR) of 37% over the 2023 to 2030 forecast period.

The celebration also noted that the California site recently was granted EMA regulatory approval for the manufacturing of sterile, biological medicinal products, and quality control testing specifically for Atara Biotherapeutics' Ebvallo™ (tabelecleucel or tab-cel®), a monotherapy approved in Europe for adults and children with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (r/r EBV+ PTLD).

"The completion of the expansion at our California cell therapy facility demonstrates our ability to support the growing needs of our early-to-late-stage allogeneic customers and late-phase autologous customers for commercial cell therapies," said Lars Petersen, president and CEO, FUJIFILM Diosynth Biotechnologies. "As our industry realizes the promise of precision medicine, we are pleased to be at the ready to support production at our California facility, with the specialized skill and expertise of our team on-site."

"We're thrilled to have FUJIFILM Diosynth Biotechnologies as part of our biotech hub, contributing to our community's growth and prosperity. This expansion will not only advance scientific research but also create new job opportunities for local residents," said Thousand Oaks Mayor Al Adam.

"I am very proud of our entire team for reaching these important milestones, which will benefit patients that rely on these important cell therapies," said Dave Bolish, site head of FUJIFILM Diosynth Biotechnologies, California. "The recent EMA GMP certification exemplifies that our high-quality manufacturing processes, systems, talent, and world-class facility meet regulatory requirements, and we have the agency's trust to manufacture and deliver product on behalf of our partner."

FUJIFILM Diosynth Biotechnologies' site in California has the flexibility to produce both clinical and commercial cell therapies, with significant experience in allogeneic T cell and CAR T immunotherapies.

The expansion was announced in December 2023 as part of FUJIFILM Corporation's overall $200 million investment package in cell therapy development and manufacturing to grow the Company's network of life sciences offerings. The investment package funded expansion of FUJIFILM Diosynth Biotechnologies' California site, and FUJIFILM Cellular Dynamics, Inc.'s new headquarters in Madison, Wisconsin. FUJIFILM Cellular Dynamics' new headquarters with cell therapy manufacturing will be operational in 2026.