Downstream Process Development

At Fujifilm Diosynth Biotechnologies we have a wide range of column sizesRepresentative Material is Key

The Downstream Process Development team is instrumental for the production of material that will support critical Process and Analytical activities such as Pre-Formulation and Formulation Development, Analytical Development, preparation of Reference Standards and cleaning verification among others.

Our Team also can meet our customer’s needs of material to support a variety of Pre-Clinical activities such as toxicological studies.

Downstream Solutions for Long Term Success

TecanOur Downstream experts can develop a solution for the purification of biologics and vaccines using a very broad range of purification chemistries. We have developed platforms for formats such as Monoclonal antibodies, as well as utilizing a streamlined approach for the purification of other proteins. In addition we offer specialized virus purification experience.

Employing the latest equipment, including ÄKTA Avant/ Explorer systems, large scale bioprocess systems, Tecan robotic among other technologies, we efficiently develop processes that are scalable, robust and cost effective. During a process transfer, we work with our customers to improve and optimize the processes they have developed, with a focus on providing long term manufacturability and cost-of-goods reduction.

Downstream Development Activities include:

  • Resin screening
  • Intermediate stability
  • UFDF development
  • Protein refolding
  • Protein modifications
  • Pegylation, hapten conjugation, enzymatic cleavage
  • Set processing targets
  • Virus clearance studies support
  • Process characterization
  • Scale down models
  • Scale up of Downstream Process
  • Ultracentrifugation (viral products)