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Scale increase

Pilot scale (3-12 kg)

  • Preparation of pilot scale production technology
  • Preparation of production documentation, production validation
  • Production of pilot scale batches (with ICH stability analysis)

Industrial scale (50-250 kg)

  • Preparation of industrial production technology
  • Preparation of production documentation
  • Preparation of production validation plan
  • Production of industrial batches (with ICH stability analysis), validation
  • Validation report