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.
Early phase development phasing
- POC vs long-term
- Adherent / suspension
- Large installed base
- Annual maintenance production
- Different lifecycle curve to recombinant protein
- From 50L for commercial to many 2k
- Design for multi-product
- Mobile Clean Room Technology
- Fully segregated and self-contained units
- VHP-based cleaning and rapid change-over
- Connectable MCRs as needed (i.e., Upstream, Recovery, Downstream)
- Near exclusive use of single-use technology, from cell bank to product vial
- Fully functional Process and Analytical development, and Virology sections
- Extensive Quality system, multiple clinical viral and non-viral bulks released
- High-speed robotic viral product fill finish 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.