Large Scale Purification
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- Solid-state development
- High-temperature reactions
- Preparative HPLC and large vessels ( >200 L)
- API purification from kg to tons
Many CROs are experienced with large scale API purification in full compliance with ICH Q7 guidelines and Annex 18 of the EU guidelines. They provide assistance and help develop best strategies for finalizing the manufacturing process for APIs including small molecules, formulations, and protein-based pharmaceuticals under GMP compliance.
Large scale API purification commonly is outsourced to CRO chemistry manufacturing experts for delivery of kg to ton quantity under GMP conditions. They will work with your team to develop solid-state chemistries with preparative HPLC for small molecules or large scale protein isolation chromatography, ultimately leading to launch phase manufacturing processes.
Timely and reliable API purification under GMP conditions is an essential element of scaling from drug discovery to the clinic. CROs can advise you on the best methods necessary to rapidly advance your lead compounds through the drug development process.
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