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DEVELOPMENT
Process Development
Ensure Consistent CGMP Performance
In preparing for 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 are for success. 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 |
(12) 2 L, (4) 20 L and (1) 250 L bioreactors; 10 L and 25 L WAVE Bioreactor®; POD filtration system |
| Purification Equipment |
ÄKTAexplorer®, ÄKTApilot®, ÄKTApurifier®, ÄKTAready® purification skid and UFDF |
ÄKTA, ÄKTAexplorer, ÄKTApilot, ÄKTApurifier and WAVE Bioreactor are registered trademarks of GE Healthcare Bio-Sciences.
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ONE SOURCE
ONE LOCATION
How can our one-source, one-location model simplify your contract manufacturing?
Contact us to learn more
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