cGMP Contract Manufacturing

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.

FermentationOur track record includes the production of over 1,000 cGMP batches and outstanding regulatory record that includes being licensed for the manufacturing of six commercial products. As a partner, we provide tailored and cost-effective manufacturing solutions to our customers, based on the unique requirements of their programs.

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 cultureCell 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

microbial fermentationMicrobial Manufacturing

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 containmentHigh Containment Manufacturing

Our manufacturing capabilities include viral and microbial vaccine production which allows us to offers a unique manufacturing proposition, with state of the art segregation and containment in flexible purpose built facilities, for these challenging product types.

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