Implementación de las normas de correcta fabricación de una terapia avanzada en una institución hospitalaria

Advanced Therapy Medical Products (ATMPs) are innovative treatments which include somatic cell therapies, genetic therapies and tissue engineering. The most important discoveries regarding these therapies are and have been driven by academic institutions, but only pharmaceutical industries used to have the facilities and the expertise to manufacture them under the regulatory framework of Good Manufacturing Practices (GMP) standards, essential to obtain manufacturing authorization from health authorities in Europe. However, in the past decades we have seen a revolution in this traditional paradigm, as academic centers, including hospitals and public research institutions, have built their own GMP compliant facilities in order to develop their own personalized patient treatment programs. This change of model brings enormous benefit to patients and to the healthcare system, as the costs of these therapies are considerably reduced, more patients can receive them, and the development of new therapies is boosted by the possibility of carrying out early-phase clinical trials with drugs discovered, developed and manufactured by academic institutions in a personalized way attending to the patients demand. In this project, the corresponding validations of the environmental conditions of the facilities, the qualification process of an equipment involved in quality control, and the production process of a T-cell based with a chimeric antigen receptor therapy (T-CAR), were carried out to verify that the Advanced Therapies Production Unit (up-MTA) of the Hospital Universitario La Paz fulfills the GMP guidelines for ATMPs. Once the tests have been carried out, the results obtained indicate that the up-MTA complies with the specifications of the GMP guidelines and that therefore it is closer to its goal of obtaining the manufacturing authorization from the Spanish Medicines Agency (AEMPS)