Advanced Therapies Unit

The Advanced Therapies Unit of the Instituto de Investigación Sanitaria La Fe, is a Transversal Platform that offers its services both to groups belonging to the hospital itself, as well as to those external users who require specially designed infrastructures under the most demanding regulatory framework for the development of pre-clinical and clinical studies within the Advanced Therapies programs.

The Unit complies with the requirements established in the European Union's Good Manufacturing Practices for Medicinal Products (NCF Compliance Certificate No. ES/0051/19), guaranteeing the quality, safety and efficacy attributes of the medicinal products produced there.

Advanced therapy medicinal products are medicinal products for human use based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering) and include products of autologous, allogeneic or xenogeneic origin. They constitute new therapeutic strategies, and their development will contribute to offering opportunities for some diseases that so far lack effective treatments.

The development of advanced therapies is one of the most important challenges of 21st-century medicine. The incorporation of these therapies into clinical practice provides a direct connection between basic research and clinical research. The medicine of the future is focused on personalized medicine, where advanced therapies will undoubtedly play a very important role. Being able to offer patients the possibility of having this medicine within their reach would contribute to excellence in clinical practice.

The Unit promotes and provides scientific-technical support for the correct manufacture of advanced therapy drugs under investigation, used in clinical trials, or provided under compassionate use, all with the authorization of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).