Integrated project development
APR manages all steps in the transfer to GMP facility (technical and analytical transfers) and the activities are the following:
> Up-scaling: Usually, before the preparation of the GMP Batch, it is necessary the preparation of an up-scaled batch
> Production of batch according to GMP for clinical purpose: If required a GMP 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: is completed with the manufacture of three validation batches.