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Gene therapy and viral products cGMP production

Facilities and capabilities

FUJIFILM Diosynth Biotechnologies is a leading CDMO with world-class cGMP compliant facilities that offer effective and reliable production of gene therapies and vaccines.

Our solutions are highly flexible and support both upstream production based on cell culture expression and microbial fermentation, as well as optimized downstream purification.

Two state-of-the-art facilities offer global services based on extensive experience in the scale-up and cGMP production of gene therapy and viral products.

  • The National Center for Therapeutic Manufacturing is designed for Process Development and Phase I/II GMP production of gene therapies (Viral, Microbial, Plasmid)
  • The Flexible BioManufacturing Facility is designed for cGMP production of Viral and Gene Therapy products Phase I-III and Commercial

Assets for every stage of product lifecycle

We provide manufacturing assets for every stage of your product lifecycle, from pre-clinical development to commercial production.

Clinical Trial Production graph
Brochure corporate capabilities

Fill Finish Capabilities

Our fill/finish services in gene therapy deliver high value at minimum patient risk. We provide a fully cGMP compliant and minimum risk service. We use a carefully selected gloveless robotic isolator, Vanrx SA25 Aseptic Filling Workcell with no contact hazard pathway – and robust Gen 3 Mobile Cleanroom for efficiency and safety containment.

Please see Extended Full Services, for more details about fill/finish including formulation, vial filling, stability testing and release of Licensed Products.