Dedicated facilities to advance the monoclonal antibody therapies of tomorrow
FUJIFILM Diosynth Biotechnologies offers a full range of process and analytical development services, combined with flexible cGMP contract manufacturing assets, to support you through the full life cycle of your product, from cell line development to clinical supply and all the way to commercial production.
Developers of cell culture-based therapies need reliable and proven partners with the development and manufacturing experience to support the delivery of therapies to patients.
What is Saturn?
The foundation of FUJIFILM Diosynth’s Saturn mAb Platform lies on over 25 years of analytical and process development and manufacturing experience. The platform has built-in best practices and latest equipment and process technologies.
It provides regulatory compliant processes, facilities and systems with the potential for providing earlier access to mAb cGMP manufacturing and disposition, allowing our partners to meet critical timelines in their CMC journey.
Features of the Saturn mab Platform™
- Dedicated Saturn laboratories and Saturn GMP production facility. No need to share manufacturing capacity with non-mAb programs.
- Designed to support mAb therapies from Early to Late Phase Clinical Stage all the way to Commercial Manufacturing in a high throughput, multi-product facility.
- Analytical Platform Methods already developed, ready for implementation, mitigating Analytical Development related risks. Analytical Methods supported by extensive characterization capabilities.
Built-in options to meet customer needs
Our customers have different needs, based on the stage of development of their therapeutic mAb candidate. This was a guiding principle in the development and design of the Saturn mAb Platform™.
Saturn mAb Plus™ Programs
We offer Saturn Programs that are suitable for customers that do not have an established cell line and are looking for a full service solution. The Saturn mAb Plus incorporates FUJIFILM’s Apollo™ Mammalian Expression System to the full Saturn Process Platform Implementation. Manufacturing capacity access is built-in within the full program offer.
Saturn mAb Transfer™ Programs
The Saturn Programs were also designed to support customers with already established cell lines. These programs start with a rapid Platform Fit Assessment to ensure long-term program success. Manufacturing capacity access is built-in within the full program offer.
- High-throughput manufacturing approach provides built-in capacity access to support critical customer deadlines
- Saturn mAb Programs do not compete with non-mAb programs for manufacturing capacity.
- Platform was designed to be robust and easily optimized from Early Phase programs to Late Phase
- Platform is validation-ready
- Facilities designed to support long-term Commercial Manufacturing
- Supply chain risk mitigation to avoid program delays
- All Saturn mAb Programs incorporate FUJIFILM Diosynth Biotechnologies Quality Standards