Representative 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
Our 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)