FUJIFILM Celebrates Expansion completion of California Cell Therapy Facility

• FUJIFILM Diosynth Biotechnologies completed the expansion of its cell therapy manufacturing facility in Thousand Oaks, California, adding two new production suites.

• The site also received EMA GMP certification for manufacturing sterile biological medicinal products.

FUJIFILM Diosynth Biotechnologies, a global CDMO for biologics and advanced therapies, has completed the expansion of its cell therapy manufacturing facility in Thousand Oaks, California. The investment includes two new cGMP production suites and enhanced development labs, significantly increasing capacity for both clinical and commercial programs.

The new suites, designed for flexibility, feature advanced equipment for automated cell processing and robust decontamination systems. They are capable of supporting both autologous and allogeneic cell therapy manufacturing, meeting evolving regulatory standards. Lars Petersen, President and CEO, commented, “The completion of the expansion demonstrates our ability to support the growing needs of allogeneic and autologous customers for commercial cell therapies.”

This expansion coincides with the European Medicines Agency (EMA) granting the site GMP certification for manufacturing sterile, biological medicinal products, including production for Atara Biotherapeutics’ Ebvallo. Ebvallo is a monotherapy approved in Europe for patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease.

“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.”