cGMP Microbial Production

Complete solutions for microbial fermentation production

FUJIFILM Diosynth Biotechnologies is the leading CDMOs with expertise and capabilities in the development and optimization of microbial-based processes as well as scale up for manufacture. This experience includes:

  • Developing our microbial-based expression technology: pAVEway™ , for the efficient microbial expression of proteins.
  • Developing a license-free Pichia pastoris expression system.
  • Working with a wide range of systems including E.coli and P.pastoris, Saccharomyces and Pseudomonas.
  • cGMP production of clinical and commercial products.
3d Germs
3d render of a germ bacteria under microscope

Leaders in Microbial Process Development

We work with our partners to help establish the initial goals for a successful microbial program that will result in a High cell density process with High titers and high-yield recovery. Our Microbial Process development is supported by comprehensive in-house analytical capabilities which include mass spectroscopy, advanced biophysical methods and formulation development.

Our Microbial experience includes working with proteins that are secreted, periplasmic, or insoluble (inclusion bodies).

Upstream activities are supported by a range of fermenters including ambr250™ and DASGIP micro-reactor systems for small scale fermentation and process optimization through to 5 – 140L glass and stainless steel vessels for larger scale development activities.

Recovery and downstream equipment, ranging from bench top instruments to larger scale continuous centrifuges and process scale chromatography systems, ensures that we can properly develop and test processes which readily fit our large scale cGMP manufacturing facilities.

Microbial Manufacturing 

  • FermentationcGMP Microbial Cell Banking
  • 50L, 100L, 200L, multiple 2,000L and multiple 5,000L fermenters
  • Dedicated suites for the production of High Potency Biologics
  • Refold of inclusion bodies up to 10,000L capacity