Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization (CDMO), has completed 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 solutions such as automated cell separation, selection, and expansion equipment, 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.
 
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.”
 
“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 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.