FUJIFILM Diosynth Biotechnologies Celebrates the Expansion Completion at its California Cell Therapy Facility

Celebration also includes achieving EMA regulatory issuance of GMP certification at the site

/EIN News/ -- THOUSAND OAKS, CALIF., Nov. 20, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, today hosted a celebration for 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 GMP¹ 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.²

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.

 

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization partner to development and manufacture of biologics, vaccines, and advanced therapies. The company operates a global network with major locations in the United States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. For more information, go to: www.fujifilmdiosynth.com

 

About FUJIFILM Holdings Corporation

FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: www.fujifilmholdings.com.

For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030, click here.

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¹Good Manufacturing Practice

² Fujifilm estimates based on Evaluate Pharma® November 2023

Attachments

• FUJIFILM Diosynth Biotechnologies celebrates the expansion completion at its California cell therapy facility
• Celebration of FUJIFILM Diosynth Biotechnologies cell therapy facility expansion opening

Christine Jackman
                    FUJIFILM Holdings America Corporation
                    9142614959
                    christine.jackman@fujifilm.com