Spain's First Hospital Authorized to Manufacture Gene and Cell Therapies for Europe
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Sant Joan de Déu Barcelona Children's Hospital has become the first hospital in Spain to receive official authorisation to manufacture and export Advanced Therapy Medicinal Products (ATMPs) throughout the European Union.
The milestone represents an important step not only for Spanish healthcare but also for the continued development of personalised medicine across Europe.
European Manufacturing Authorisation
The hospital's Advanced Therapies Platform (PTA) has been granted a Manufacturing and Import Authorisation (MIA), enabling it to manufacture, distribute and export advanced cell and gene therapies to healthcare institutions across the European Union.
Until now, many of these therapies were produced primarily for patients treated within the hospital itself. The new authorisation allows Sant Joan de Déu to supply innovative therapies to other hospitals and research organisations throughout Europe.
Expanding Access to CAR-T Therapy
One of the platform's principal activities will be the manufacture of CAR-T cell therapies.
CAR-T therapy is an advanced form of cancer treatment in which a patient's own immune cells are genetically modified to recognise and attack tumour cells.
The facility has the capacity to manufacture up to 150 CAR-T products each year, increasing the availability of these highly specialised treatments for patients.
Advanced Therapy Medicinal Products
The platform supports the development and manufacture of several categories of advanced therapies, including:
- gene therapies;
- cell-based therapies, including CAR-T products;
- tissue-engineered products designed to repair or regenerate damaged tissues.
These technologies are creating new treatment possibilities for complex diseases, particularly haematological cancers, immune disorders and rare inherited conditions, where therapeutic options have traditionally been limited.
Meeting European Quality Standards
The MIA accreditation confirms that the platform complies with the European Union's stringent requirements for pharmaceutical manufacturing, including quality assurance, patient safety and full product traceability.
In addition to supporting clinical care, the authorisation is expected to facilitate academic clinical research by enabling promising therapies to move more efficiently from laboratory development into clinical practice.
As advanced therapies continue to evolve, facilities such as the Advanced Therapies Platform at Sant Joan de Déu will play an increasingly important role in making personalised treatments available to patients across Europe.