Pilot Facility for Non-GMP Drug Substance Manufacturing
Gallus’ Princeton site has a designated pilot plant facility designed to serve as the final stage of process development, for engineering runs and for production of pre-clinical non-cGMP material at intermediate scale. The suite currently features 50 L and 200 L stainless steel bioreactors and a separated downstream purification suite for production of pre-clinical toxicology materials and reference standard.
Equipment
- 50 L and 200 L ABEC stainless steel bioreactors
- 10 L to 200 L WAVE® Bioreactors for seed train scale up
- Harvest by depth filtration
- Multiple downstream processing skids
- Uniflux 30 UF/DF skid