Large Scale Microbial

A new option for very large scale microbial biologics cGMP manufacture


Complete Microbial Fermentation Solutions

Large scale microbial manufacturing has been considered a niche market. Today, drug developers are coming closer to overcome the challenges of developing orally dosed biologics, with several candidates advancing through the clinical pipeline. Other drug developers face challenges with promising candidates low yielding processes, which would require large scale production to minimize the COGs, especially as a it comes closer to commercial approval.

As a complete solutions and leader in microbial fermentation, FUJIFILM Diosynth Biotechnologies offers 20,000-Liter Microbial Biologics capacity for late-stage clinical and commercial supply. This capacity is the result of a long-term collaboration with MSD (known as Merck in the U.S. and Canada), to operate its Ireland based large scale microbial biologics facility.

Benefits

  • Addresses a market need for large-scale microbial biologics manufacturing
  • Complements Fujifilm Diosynth’s existing microbial capacity that ranges from 100L up to 5000L both in the USA and UK including refold of inclusion bodies up to 10,000L capacity
  • Enables partners to benefit from MSD’s strong track record with large-scale microbial operations and FUJIFILM Diosynth’s leading technical expertize in the development and production of microbial processes

About the facility

The facility was designed for flexible configuration and incorporating Disposable Technology (DT) such as:

  • Aseptic connections
  • Aseptic Sampling Single use filters
  • Single use bags
  • Single use Tubing and transfer sets

Additional capabilities include:

  • High intensity fermentation
  • Buffer prep using In-Line dilution

Program Execution: Right First Time

  • FUJIFILM Diosynth Biotechnologies will serve as the Primary Customer Contact including Program Management
  • Microbial processes with either be developed or established by FUJIFILM and will then be directly transfer to MSD for GMP production with FUJIFILM Diosynth technical team providing process and analytical support all through the campaign