Integrated project development
APR manages 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 - in order to minimize possible risks
> Production of batch for clinical purpose: If required a batch for a clinical purpose is manufactured as well as the formal analytical validations. On this batch a stability study according to the ICH guidelines is then performed.
> Validation: is completed , if required, with the manufacture of three validation batches.