Scale-up for clinical trial batches (Phases II and III)
The development trials support the characterization of the manufacturing process and define any critical processing parameters These data would provide the basis for further scale-up and necessary adjustments (SUPAC – Scale-Up & Post Approval Changes).

In the following Development Phase the process parameters will be defined for manufacturing instruction (MI), for the production for registration batches; long-term stability data will be generated based on the registration batches.

• Registration batches would be manufactured on production-scale equipment. The results will be summarized in a Development Report.
  
  
• Scale-up for full commercial production.
  Finalize process parameters for full-scale production prior to manufacture of validation batches and subsequent market supply.