Image Credit: Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization (CDMO) for biologics, viral vaccines, and viral vectors, recently celebrated the completion of an expansion project for its cell therapy manufacturing facility in Thousand Oaks, CA.1 The celebration was actually twofold, as it also recognized the site issuance of a Certificate of GMP Compliance of a Manufacturer via the European Medicines Agency (EMA).
The investment project was originally announced2 in December 2023 as one component of the CDMO’s $200 million cell therapy development and manufacturing investment project; the plan also involves financially supporting its Fujifilm Diosynth Biotechnologies’ California site, Fujifilm Cellular Dynamics, Inc.’s new HQ in Madison, WI, and the Cellular Dynamics’ new HQ with cell therapy manufacturing services, which is expected to be up and running by 2026.
When it comes to the Thousand Oaks location, the development project features the advancement of the development labs and welcomes two new independent cell therapy production suites to the mix, which boosts cleanroom capacity. The current good manufacturing practice (cGMP) suites are capable of automated cell separation and selection, with expansion equipment, in-built decontamination for rapid changeovers, and HVAC systems that can support either Grade B or C backgrounds.
Further, these suites can handle either open or closed processing—they’re also large enough to accommodate multiple patients’ autologous program lots, or even greater volume batches for allogeneic programs for both the clinical and commercial marketplaces.
“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.”
As alluded to previously, the California plant recently was given EMA regulatory approval, specifically for the manufacturing of sterile, biological medicinal products, and quality control testing specifically for Atara Biotherapeutics’ Ebvallo (tabelecleucel or tab-cel), which is a monotherapy that was approved in Europe for adults and children with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (r/r EBV+ PTLD).
Overall, in 2023, the global cell therapy market size was estimated to be valued at $4.8 billion, and forecasts are anticipating that the market will continue to grow at a compound annual growth rate of 37% during 2023 to 2030 forecast period.3
“I am very proud of our entire team for reaching these important milestones, which will benefit patients that rely on these important cell therapies,” commented 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.”
References
1. Fujifilm Diosynth Biotechnologies Celebrates the Expansion Completion at its California Cell Therapy Facility. Fujifilm Diosynth Biotechnologies. November 20, 2024. Accessed November 21, 2024. https://www.fujifilm.com/us/en/news/biotechnology/fujifilm-diosynth-biotechnologies-celebrates-the-expansion-completion
2. Fujifilm to Invest USD 200 Million to Expand Cell Therapy Development and Manufacturing Capabilities. Fujifilm Diosynth Biotechnologies. December 4, 2023. Accessed November 21, 2024. https://www.fujifilm.com/us/en/news/200_Million_Cell_Therapy_Investment
3. Fujifilm estimates based on Evaluate Pharma November 2023.