WuXi Biologics non-GMP pilot plant (NPP) was established in September 2011. Located in the Waigaoqiao Pilot Free Trade Zone, Shanghai, it has 1,400m2 clean suite space and offers the following capabilities:
- Material generation, for drug feasibility studies process and method development and early R&D client material requirements (e.g., preliminary toxicology or PK studies)
- IND-enabling toxicology study material generation and process evaluation for scaling up to GMP
- 1 to 3 lots non-GMP Drug Substance (DS) production for NMPA filing, including, process scalability and robustness evaluation
- Process scale-up and GMP manufacturing support, including optimization of scale-up strategy, risk assessment and mitigation for eventual GMP production
- Late-stage PC study support
- Non-GMP EOPC cell bank creation
- Non-GMP formulation buffer preparation