Saturn mAb Platform™

Advancing the monoclonal antibody therapies of tomorrow

process characterization

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?

FUJIFILM Diosynth’s Saturn mAb Platform provides regulatory compliant processes, facilities and systems with the potential for providing earlier access to mAb cGMP production and disposition, allowing our partners to meet critical timelines in their CMC journey.

Features of the Saturn mab Platform™
  • Standard mAb Platform Units of Operations.
  • Best in Class technologies selected to support all Units of Operation.
  • Analytical Platform Methods already developed, ready for implementation, mitigating Analytical Development related risks. Analytical Methods supported by extensive characterization capabilities.
  • 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.

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 customer  that do not have an establish 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. This 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.


Benefits

 

Access to cGMP Cell Culture Capacity

  • 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.

Reliable/De-risked Manufacturing

  • 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

Quality
  • All Saturn mAb Programs incorporate FUJIFILM Diosynth Biotechnologies  Quality Standards

 

Advancing Tomorrow’s Medicines.