Benefits

Time & Financial savings

  • Faster process: Hours instead of days
  • Fast iterations during formulation work
  • Major savings in later development stages: out-scaling, not upscaling
  • Manufacturing: No large batch consumption for upscaling revalidation
  • Regulatory : GMP drug candidate material in preclinical studies is comparable to clinical material
  • No manufacturing bottle-necks
  • Smaller equipment requiring less clean room space: Reduced CAPEX and OPEX
  • Zero risk of large batch loss
  • Short changeover times
continuous- vs batch-freeze-dried product
continuous-freeze-drying thermal imaging

Improved quality

  • Flexible freezing rates for optimal ice crystal formation
  • Process control at single unit dose level
  • No within-batch variability
  • No batch-to-batch variability
  • Pre-clinical materials comparable to clinical and commercial batches

Improved flexibility

  • Compatible with wide range of compounds
  • Flexible production volumes
  • Compatibility with upstream and downstream continuous manufacturing steps
continuous-freeze-drying lego concept multiplication-duplication