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Non-GMP Pilot Production

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