FUJIFILM Diosynth Completes California Cell Therapy Facility Expansion

FUJIFILM Diosynth Biotechnologies, a leading contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, celebrated the completion of an expansion at its cell therapy manufacturing facility in Thousand Oaks, California. The event also marked the issuance of a Certificate of GMP (Good Manufacturing Practice) Compliance by the European Medicines Agency (EMA), affirming the site’s regulatory approval for manufacturing sterile biological medicinal products.

The facility expansion includes upgraded development labs and the addition of two independent cell therapy production suites, increasing the cleanroom capacity to accommodate new client programs. These cGMP suites are equipped with advanced technology such as automated cell separation, selection, and expansion systems, as well as robust decontamination features to facilitate rapid changeovers. Additionally, the HVAC systems support flexible environments with Grade B or C backgrounds, essential for adapting to new modalities and evolving regulatory demands. The new suites are large enough to handle both open and closed processing, catering to autologous programs (using a patient’s own cells) or larger batch volumes for allogeneic programs (using donor cells) for clinical and commercial clients.

Cell therapy, a promising treatment for a variety of diseases, offers significant hope to patients by improving their quality of life. The global cell therapy market, valued at $4.8 billion in 2023, is expected to grow at a compound annual growth rate (CAGR) of 37% from 2023 to 2030, driven by increased research, clinical trials, and growing regulatory approvals.

The California site’s recent achievement includes EMA approval for manufacturing and quality control testing for Atara Biotherapeutics’ Ebvallo™ (tabelecleucel or tab-cel®), a therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease (r/r EBV+ PTLD) in Europe.

Lars Petersen, president and CEO of FUJIFILM Diosynth Biotechnologies, emphasized that the expansion reflects the company's ability to support the growing demand for both early-to-late-stage allogeneic and late-phase autologous commercial therapies. Petersen highlighted the company’s role in advancing precision medicine and its readiness to support production with the expertise of its California team.

Thousand Oaks Mayor Al Adam expressed pride in having FUJIFILM Diosynth as part of the local biotech hub, noting that the expansion will boost scientific research and create new jobs. Dave Bolish, site head of the California facility, praised the team’s achievements, especially the EMA GMP certification, which underscores the site’s high-quality manufacturing processes and regulatory compliance.

The expansion was part of FUJIFILM Corporation’s $200 million investment in cell therapy development, which also includes the construction of FUJIFILM Cellular Dynamics’ new headquarters in Madison, Wisconsin, set to begin operations in 2026.