Dedicated facilities to advance the monoclonal antibody therapies of tomorrow
Monoclonal Antibodies are among the fastest molecules in development for therapeutic applications. Many companies are building their clinical pipelines around monoclonal antibodies because of their wide range of disease targets, including new areas such as immunotherapies for the treatment of many cancers. Other reasons include relative ease of manufacturing and well established regulatory precedence. As of January 2017, the FDA has approved 68 therapeutic Monoclonal Antibodies. This number is expected to increase with over 400 Monoclonal antibodies currently in development.
Expeditious development of monoclonal antibody processes and efficient transfer to GMP production are of the essence in the race to find what in many cases are life saving treatments. Developers of monoclonal antibodies need reliable and proven partners with the development and manufacturing experience to support their programs.
What is Saturn? A new approach to deliver to monoclonal Antibodies
Saturn is a monoclonal antibody process platform with dedicated Process Development laboratories and dedicated GMP manufacturing facilities capable of delivering clinical and commercial therapeutics.
The foundation of FUJIFILM Diosynth’s Saturn mAb Platform was built on its 25+ years of analytical and process development and manufacturing experience. The platform has built-in best practices and latest high throughput process development technologies, such as the ambr™ platform which provides a high precision environment to assess production processes and perform DoE studies without extending timelines.
The dedicated GMP facilities are built around single-use technologies and offer 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