As a manufacturing network, we offer our partners highly flexible clinical and commercial cGMP facilities for the production, by microbial fermentation and cell culture, of biologics including gene therapy and vaccine products, including viral vaccines requiring high containment.
Our Technology Transfer approach is well-established and protocol-based. Whether it is transferring a customer process to our facility or implementing a process we have developed, we start the Manufacturing Process by defining Operational Success with our customers. Excellence in execution is achieved by our leading approach that encompasses Process training, On-floor support, Batch Release, and Campaign review.
Manufacturing Capacities Across Our Network
FUJIFILM Diosynth Biotechnologies is a world-leading CDMO in the cGMP production of cell culture and microbial-based biopharmaceuticals. We also have the ability of working with Virus Replication Host Platforms and Viral Vectors.
Cell Culture Manufacturing
As a leading manufacturer we offer our partners extensive expertise and capabilities in the development and optimization of cell culture-based processes as well as scale up for manufacture.
Our Global Cell Culture cGMP Capacity includes:
- Stainless Steel: 650L and 2,000L bioreactors
- Single Use: 200L, 500L, multiple 1,000L and multiple 2,000L bioreactors
- Hollow Fiber and Stack Cell Culture Systems
Our experience includes the development and scale up of PEGylation unit operations and refold of inclusion bodies up to 10,000L capacity.
Our Global Microbial Fermentation cGMP Capacity includes:
- Microbial cGMP Cell Banking
- 50L, 100L, 200L, multiple 2,000L and multiple 5,000L fermenters
- Dedicated suites for the production of High Potency Biologics
High Containment Manufacturing
Our cGMP High Containment Capabilities include:
- Mobile Clean Rooms and traditional manufacturing space offering flexible process siting and complete product segregation for cGMP production
- BSL-2+ ready and BSL-3 capable