ChemPartner’s pilot-scale Drug Product service experts manufacture cGMP compliant liquid and lyophilized drug product. Aseptic drug product manufacturing includes selection and qualification of the primary packaging materials, process development, manufacturing of biologics as liquid and lyophilized products under cGMP compliant conditions. The drug product batches can be used for toxicological and stability studies as well as for clinical studies.
Upstream
- Cell banking (class A/C)
- Media prep ( class D)
- Cell culture area (class D)
Downstream
- Buffer prep (class D)
- Initial Purification (class C)
- Final purification (class C)
Filling and Finishing
- Component prep (class C)
- Aseptic Filling and Capping (class A/B)
- Lyophilizaton (class A/B)
