Integrated project development
APR manages all steps in the transfer to qualified facility (technical and analytical transfers) and the activities are the following:
> Up-scaling: Usually, before the preparation of the Industrial Batch is necessary the preparation of an up-scaled batch
> Production of batch for clinical purpose: If required a batch for a clinical purpose is manufactured as well as the formal analytical validations. On the GMP Batch a stability study according to the ICH guidelines is then performed.
> Validation: if required is completed with the manufacture of three validation batches.