GMP Development and Manufacturing

gmpAs a result of our experience coordinating the ten GMP laboratories belonging to the Andalusian Public Health System, we have been able to improve and shorten the timeframe required for the development and manufacture of advanced therapy medicinal products.

This proven experience has allowed us to develop more than ten products in advanced therapies according to the strictest national and international guidelines with the collaboration of experts in the establishment of appropriate quality systems.

The network of GMP laboratories coordinated by the Coordination Unit of the Andalusian Initiative for Advanced Therapies represents the most important network of public GMP laboratories in Spain. They are mostly located on hospital complexes allowing keeping all clinical aspects under one roof and enhancing profitability as a result of economies of scale. This network, open to collaboration with biotechnology and pharmaceutical companies, facilitate the development of different parallel projects and their localization in the most suitable hospital centres according to efficiency criteria. + info at Network of GMP Laboratories

 

The Coordination Unit of the Andalusian Initiative for Advanced Therapies is committed to fostering synergies. In this regard, we have developed several alliances with institutions, research groups and companies.

The areas of cooperation are wide ranging. They cover every step in the development of advanced therapy medicinal products including basic research, pre-clinical regulations, regulatory and scientific advice, and clinical development as well as the processes involved in patent licensing and know-how.

All these collaborations have been developed in a framework of mutual and strategic benefit striving to enhance the generation of an effective business hub in the field of advanced therapies and regenerative medicine.