Pilot Scale Production
Pilot scale production that bridges development and GMP supply. We run representative batches at intermediate scale to confirm process performance, generate material for tox and stability work, and de-risk the transfer into cGMP before the expensive campaign begins.
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)
