Viral Vector and Vaccine cGMP Production
Facilities and capabilities
As a leading CDMO with world-class cGMP compliant facilities, FUJIFILM Diosynth Biotechnologies offers effective and reliable production of viral vectors and recombinant vaccines.
We develop processes designed to support both adherent and suspension cells.
Two state-of-the-art facilities offer global services based on extensive experience in the scale-up and cGMP production of viral products with manufacturing scales up to 2,000L.
- The National Center for Therapeutic Manufacturing – process development and cGMP production to support Phase I/II clinical requirements.
- The Flexible BioManufacturing Facility – cGMP production to support Phase I-III clinical and commercial requirements.
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.
Phase-appropriate process development
- Scalable process development strategies
- Process development strategies that support both early and late- phase CMC requirements
- Adherent: CellSTACK and HYPERStack platforms
- Suspension: 10L to 2000L Single-Use Xcellerex and WAVE Bioreactors
- 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
Our state-of-the-art fill/finish facility delivers high value, cGMP compliant products, without compromising the product quality attributes. To achieve this, we use the Vanrx SA25 Aseptic Fill Workcell, an integrated, touchless robotic isolator, housed in a Generation 3 Mobile Cleanroom to ensure the highest standards of precision and containment, with minimal product losses.
Please see Extended Full Services, for more details about fill/finish including formulation, vial filling, stability testing and release of Licensed Products.