SCALE-UP PROGRAM

Scale-Up

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing with a succesfull track record since 1997.

Using state of the art development tools, we optimize and ensure a smooth transition from small scale to full scale development, through validation and process control all along the drug development cycle.

We ensure :

  • Equipment qualification
  • Process validation
  • Single point of contact with a dedicated project team
  • Regular process review and optimisation
  • Competent and highly qualified team

Manufacturing of Clinical Trial Materials

We use our cGMP facilities to supply materials for clinical studies supporting the regulatory process.

Skyepharma’s oral drug delivery services include scale-up and the manufacture of clinical trial materials : regardless of your starting point, we lead your projects to the next manufacturing stage quickly and professionally whether it is a new, modified or existing formulation.

  • Small API needs
  • Process validation – Design of Experiment support
  • Process robustness
  • Rapid study of parameter impact on product specifications
  • Support for choice of best equipment for production
  • Technology transfer issue anticipation