Capabilities:

• Easy transfer, verification and optimization of clients’ existing bioreactor process
• Platform bioreactor processes for a variety of mammalian and microbial expression systems
• Medium Development
• Identification of critical process parameters based on design space mapping/process characterization
• Development of process control strategies
• Bench-scale process characterization and validation
• Scale-down validation studies

Downstream Process Development

We have a proven track record of developing successful downstream processes for multiple biotherapeutics, including: monoclonal antibodies, recombinant proteins, glycoproteins, bacteria, and yeast.

We have optimized our downstream impurity removal processes to minimize steps and maximize yield resulting in cost savings to the customer.

For our microbial processes, we have the ability to purify directly from harvest or to refold proteins from inclusion body preparations.

Additionally, our process development teams are fully integrated with our analytical development teams to ensure we achieve rigorous product quality attributes.