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Cell and Gene Therapy cGMP Production

End-to-End Services

As a leading CDMO with world-class cGMP-compliant facilities, FUJIFILM Diosynth Biotechnologies offers end-to-end services for the production of cell and gene therapy products and recombinant vector vaccines.

Fully Equipped Facilities, Leading Edge Technology

Our GMP facilities represent the leading edge of mobile clean room (MCR) and single-use technology implementation, able to support cGMP manufacturing and QC release of drug substance and drug product for pre-clinical, clinical, and commercial supply.

Local Service, Global Partnership

We continue to expand our global footprint in the United States and in Europe, and have recently established hubs in Darlington, UK, Watertown, Massachusetts, USA, and Thousand Oaks, California, USA, in addition to our facility in College Station, Texas, USA.

Already committed investment plans mean that we will soon be able to support late phase clinical and commercial cell and gene therapy manufacturing in the United Kingdom in addition to the United States.

  • Dedicated facilities to support early phase, ’First in Human’ programs
  • Lines of sight to late phase clinical and commercial supply as programs evolve
  • Globally integrated equipment and quality systems
  • Seamless technology transfer with single, main point of contact for client

Drug Product Capabilities

Our drug product manufacturing (fill/finish) facility in College Station, Texas, USA, contains two Vanrx SA25 Aseptic Fill Workcells, each housed in a Generation 3 Mobile Clean Room (MCR).  The state-of-the-art integrated, touchless robotic systems deliver the highest standards of precision and containment, with minimal product losses, providing high value, cGMP compliant products, without compromising product quality attributes.

Please see Extended Full Services, for more details about our drug product manufacturing (fill/finish) capabilities including formulation development, vial filling, stability testing and release of licensed products.