Sunday, December 4, 2022

Andalusian laboratories for advanced therapy drugs: the place where hope is created

July 22, 2022
Andalusian laboratories for advanced therapy drugs: the place where hope is created

Andalusia’s public health system has recently achieved a major milestone in improving the health of the population. Professionals from up to seven organisations linked to the Regional Ministry of Health and Families have for the first time successfully implanted personalised veins in a patient suffering from deep vein insufficiency.

This achievement is the result of a clinical trial developed in the Andalusian healthcare system and promoted by the Swedish company Verigraft Iberia, under the coordination of the Andalusian Network for the Design and Translation of Advanced Therapies (Radytta) of the ‘Progreso y Salud’ Foundation. It has been possible thanks to the work of all the professionals involved from the different participating organisations (regional transplant coordination; Andalusian public hospitals; Radytta coordination unit) but also, and at the same time, thanks to the research infrastructures of the Andalusian public health system.

In order to carry out this clinical trial of advanced therapies, focused on the generation of artificial veins through tissue engineering, the Andalusian network of GMP laboratories of advanced therapies of the Andalusian public health system has been used. This is the largest public network of its kind in the country and, thanks to it, clinical trials such as this one can be carried out, research work that allows advances to be made in the knowledge of diseases and their treatment, especially those for which there is currently no cure.

GMP (Good Manufacturing Practices) laboratories are laboratories in which medicines for human use are manufactured, in this particular case advanced therapies, i.e. medicines obtained from cells, genes, or tissues. There are 10 such laboratories in the Andalusian public health system in the provinces of Cordoba, Granada, Malaga, and Seville, one of which is for training purposes only (located in Granada’s clinical simulation centre).

In these spaces, which meet the requirements of the Spanish Agency for Medicines and Health Products for the manufacture of these medicines, 1,115 doses of advanced therapy medicines have been manufactured to date, which have either been used to treat more than 700 patients in clinical trials or have been administered on a compassionate use basis. They have even been incorporated into the service portfolio of Andalusian public hospitals, as in the case of artificial skin for severe burns or chondrocytes for joint injuries.

Currently, there are 16 clinical trials underway in the field of advanced therapies coordinated by the Andalusian Network for the Design and Translation of Advanced Therapies. They cover the areas of ophthalmology, cardiology, dermatology, neurology, vascular pathology, and infectious diseases. A further seven are in the preparation phase.