SJD Barcelona has been awarded European MIA accreditation to produce advanced therapies for other centres

The Advanced Therapies Platform (PTA) at SJD Barcelona Children's Hospital has been awarded European MIA (Manufacturing and Import Authorisation) accreditation, which enables it to operate as a fully-fledged pharmaceutical laboratory. Thanks to this authorisation, the PTA can produce medicines, not only for its own patients but also for other hospitals and companies, and even ship them to other European countries.

As a result, SJD Barcelona has become the first hospital in Spain whose manufacturing facilities can operate at this level – that is, as a pharmaceutical company capable of exporting medicines produced on its premises throughout Europe.

This achievement is of great significance for SJD Barcelona, as it confirms that the hospital is one of the leading centres for advanced therapies and personalised medicine. Furthermore, it enables the hospital to continue developing innovative treatments and to speed up the process by which patients can benefit from the results of its research, thereby strengthening its reputation both in Spain and abroad.

Up to 150 CAR-T therapies per year

Advanced therapies include gene, cell and tissue engineering therapies, designed to correct genetic abnormalities, restore cellular functions or regenerate damaged tissues. These represent a new generation of treatments for complex diseases, particularly those for which there are no effective therapeutic alternatives, such as rare, immunological and oncohaematological diseases.

In this context, the Advanced Therapies Platform will be able to achieve a production capacity of up to 150 CAR-T therapies per year, significantly expanding access to this type of advanced treatment and facilitating its development both for in-house projects and in collaboration with other centres and institutions.

With MIA accreditation, alongside the GMP (Good Manufacturing Practice) accreditation obtained in 2024, the Advanced Therapies Platform guarantees that its manufacturing processes are safe, reliable and of high quality. This is essential to ensure that the treatments being developed can subsequently be used on patients, whilst complying with all the required standards. As a result, it will be easier to drive forward clinical trials and ensure that new treatments reach the people who need them sooner.

Alessandra Magnani, head of the Advanced Therapies Platform, comments that “obtaining MIA accreditation recognises the work carried out over recent years by the entire Advanced Therapies Platform team and reinforces our commitment to developing new, innovative therapies for paediatric and adult patients with serious illnesses”.

Magnani also emphasises that “this accreditation will enable us to expand our capabilities in the production and development of advanced therapy medicinal products, as well as to establish new collaborations with research groups, hospitals and institutions both nationally and internationally”.