Drug Product cGMP Fill & Finish
We provide fully automated final drug product formulation and filling under cGMP conditions as defined by the worldwide regulatory agencies including US FDA, EMA, NMPA and agencies from other countries or regions such as Japan, Korea, Taiwan, Singapore, Australia, Israel and India.
- Both liquid and lyophilization formulation and fill
- Both biologics and aqueous non-cytotoxic and non-antibiotic small molecule parenterals
- Dedicated formulation and filling facility for antibody drug conjugate (ADC) drugs or other highly-potent drug products
- Multiple validated container & closure configurations (2 mL, 6 ml, 8 mL, 10 ml, 14 ml, 20 mL and 50 mL)
WuXi Biologics only utilizes the highest qualified containers, closures and raw materials provided by the world’s leading suppliers.
Equipment / Capacity
- Fully automated vial wash, depyrogenation, filling and capping line with restricted access barrier system from Bosch offering a capacity from 3,000 to 12,000 (2 mL) vials per hour or 24,000 to 100,000 (2 mL) vials per batch.
- Tofflon 5 square meter lyophilizer with fully automated loading/unloading, WIT and CIP/SIP offering capacity from 5,000 to 20,000 vials per batch
- Flexible small-scale sterile filling, up to 3000 vials per batch, with Nitrogen blanketing (Flexicon bench-top filling line)
Future Planned Expansion of Global Capacity
|Site||DP Capacity||GMP Ready||Location||Comments|
|DP2||Liquid vial with lyophilization||2020||Wuxi city||Commercial|
|DP3||ADC conjugation and DP||2020||Wuxi city||Clinical|
|DP4||PFS||Q3 2019||Wuxi city||Clinical|
|DP5||Commercial PFS||2021||Wuxi city||Commercial|