Process Development

“Combining a purpose-built facility and experienced development scientists”

  • 001Pilot scale facility with relevant technology, equivalent to those used in GMP stages.
  • Services for developing and optimization of lyophilization cycles .
  • Challenge of complex aspects of the formulation, such as temperature, viscosity, contact with production materials that could induce aggregation or other changes in the molecule.
  • Simulation of formulation, filling, lyophilization and closing procedures.
  • Design space calculation based on DoE and other Six Sigma tools.
  • Engineering, stability, and validation batches and previous physico-chemical characterization.
  • All in-house validation support.

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