The treatment of patients with advanced therapy medicinal products demands that these medicinal products be manufactured in specially designed infrastructures under the strictest regulatory standards. These infrastructures are known as white rooms or Good Manufacturing Practice (GMP) laboratories.
The Coordination Unit of the Andalusian Initiative for Advanced Therapies coordinates a network of GMP laboratories which belong to the Andalusian Public Health System. They are for the most part located in hospital centres, regional blood transfusion centres or science parks.
This network of GMP laboratories is accessible to the scientific community and to society. Services are situated close to the patient and benefit from the economy of scale and scope by reducing the costs entailed in outsourcing services provided. This network also allows us to diversify and be of the assistance to multiply parallel projects.
This network of GMP laboratories requires demanding and complex quality systems designed and maintained by highly qualified personnel. It supports projects and research in the field of advanced therapies at regional level as well as nationally and internationally. The creation of this organizational network also facilitates the development of diverse parallel research projects in the most suitable hospital centre according to the competence criteria required. Similarly, the manufacturing requirements for the manufacture of advanced therapy medicinal products also vary according to the type of processing required.