Process Development

Process-Development

From cell culture through recovery and purification, the process scientists at Catalent Biologics develop processes that ensure consistent cGMP manufacturing performance and a reliable product supply.

How Process Development Works

In preparing for Current Good Manufacturing Practices (cGMP) production, the process development group’s initial goal is process characterization, which provides an understanding of how robust the process is, how it behaves as conditions change, and what the critical parameters for success are. The development laboratory is equipped with best-in-class scale models for strong predictive power in the cGMP production environment. 

Catalent Services

Process development can be performed on monoclonal antibodies, recombinant proteins and biosimilars in mammalian cell culture.

Key Services:

  • Vector design
  • Cell line development
  • Media and feed screening and optimization
  • Bioreactor process definition
  • Optimization and scale up
  • Harvest optimization
  • Chromatography optimization
  • UFDF optimization
  • Viral clearance

Cell Culture Equipment:  Sixteen 2 L, four 20 L, one 50 L, one 200 L and two 250 L bioreactors; 10 L and 25 L WAVE Bioreactors™; POD filtration systems
Purification Equipment:  ÄKTAexplorer, ÄKTApilot, ÄKTA avant, ÄKTAready, ÄKTAcrossflow, and Pellicon hodlersWAVE Bioreactor and ÄKTA are trademarks of GE Healthcare Bio-Sciences Corp.