Drug Product Manufacturing of Microbial-derived Products
WuXi Biologics provides a full scope of drug product (DP) manufacturing services for microbial fermentation-derived therapeutics and vaccines, which includes process development, tech transfer, facility fit, robustness evaluation of DP manufacturing process.
Highly flexible and automated DP GMP manufacturing
- 2× Vanrx SA25 robotic aseptic filling lines for clinical DP manufacturing (see below for more information on this state-of-the-art isolator-based system)
- Aseptic formulation for Alum adjuvanted vaccines
- Flexible container-closure systems including vials (2R to 20R) and prefilled syringes (1 mL to 3 mL long and normal). All primary packaging materials are ready-to-use (RTU)
- Single-use systems covering the entire equipment train with no shared product contact surfaces
Fully-automated, robotic, gloveless, isolator-based Vanrx aseptic drug product fill system at WuXi Biologics
In addition to Hangzhou site, fill of biologics and vaccines drug substance produced via microbial fermentation can also be performed in our various manufacturing facilities globally, including lyophilized dosage forms.