Process Development
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.
Ensure Consistent CGMP Performance
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. From cell culture through recovery and purification, the process scientists at Cook Pharmica develop processes that ensure consistent CGMP manufacturing performance and a reliable product supply.
Quick Capability Reference
| Product Types | Monoclonal antibodies, recombinant proteins |
| Expression System | Mammalian cell culture |
| Key Services | Vector design, cell line development, media and feed optimization, bioreactor process optimization and scale-up, harvest optimization, chromatography optimization, UFDF optimization, viral clearance studies |
| Cell Culture Equipment | Twelve 2 L, four 20 L and one 250 L bioreactors; 10 L and 25 L WAVE Bioreactor®; POD filtration system |
| Purification Equipment | ÄKTAexplorer®, ÄKTApilot®, ÄKTApurifier®, ÄKTAready® purification skid and UFDF |