The Coordination Unit of the Andalusian Network for the design and translation of Advanced Therapies fosters progress in the field of advanced therapies by supporting all phases related to the development of these medicinal products. The pre-clinical or non-clinical (regulatory term) research is one such phase which precedes the design of a clinical trial in humans.

Pre-clinical research is of extreme importance to guarantee the safety and efficacy of medicinal products in research which must be later demonstrated through clinical research in human beings.

There are nowadays many diseases for which there is still no effective treatment. In the case of certain of these, we are making some advances in the research to find a treatment using advanced therapy medicinal products (cell therapy, tissue engineering and gene therapy). The Andalusian Network for the design and translation of Advanced Therapies has, as one of its main objectives, to facilitate access to those therapies to the Andalusian population on an equitable basis whilst guaranteeing their administration under the strictest legal requirements and the highest safety.

In this regard, the work of this Andalusian Network ranges from manufacturing advanced therapy products considered in most cases as medicinal products, to setting up and monitoring a range of clinical trials in phase I/II and III, to show their safety and efficacy and subsequently to incorporate these therapies into routine clinical practice in the near future.

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 Network for the design and translation of Advanced Therapies (ANd&tTA) 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.

Advanced therapies comprise cell therapy, gene therapy and tissue engineering. For the most part, these are considered a special type of medicinal products. The only exception is the cell therapy which is considered as a cell transplant and not as a medicinal product when the cells are not subject to substantial manipulation and are used to carry out their normal function or essential functions.