Cell Culture cGMP Production

Advanced cell culture cGMP manufacturing

FUJIFILM has extensive expertise and capabilities in the development and optimization of cell culture-based processes, as well as the ability to scale up for manufacturing. This experience includes:

  • Development and/or process transfer of CHO monoclonal and non-monoclonal antibody programs
  • Large scale insect cell / baculovirus expression of vaccine products including VLPs
  • Experience with adherent and suspension based cultures
  • cGMP production of clinical and commercial products

Efficient Monoclonal Antibody Manufacturing

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 lifesaving treatments. Developers of monoclonal antibodies need reliable and proven partners with the development and manufacturing experience to support their programs.

The Saturn mAb platform is a Monoclonal Antibody Platform for reliable delivery of therapeutics. The dedicated cGMP 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. Some of the benefits of the Saturn GMP cell culture production facility include:

  • 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

Global Manufacturing Capabilities

  • 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