Sant Joan de Déu, the first Spanish hospital to produce advanced therapies for public and private institutions in Europe

The Advanced Therapies Platform (PTA) at SJD Barcelona Children's Hospital has obtained MIA (Manufacturing and Import Authorization) accreditation, the regulatory authorization that enables a center to operate as a pharmaceutical laboratory for the production and distribution of advanced therapy medicinal products.

Unlike the GMP (Good Manufacturing Practice) certification that the PTA already held-which guarantees the quality of manufacturing processes-MIA grants the legal capacity to produce medicinal products for other centers and pharmaceutical companies, and to export them to other countries within the European Union. With this authorization, SJD Barcelona Children's Hospital (HSJD) becomes the first Spanish hospital whose cleanrooms can operate with this industrial and European export scope.

Advanced Therapies

Advanced therapies include gene therapies, which introduce, correct, or modify genes to treat the cause of a disease; cell therapies, which use cells that have been selected, cultured, or modified to restore function or combat disease; and tissue engineering therapies, which regenerate, replace, or repair damaged tissue. All of these represent a new generation of treatments aimed at addressing complex diseases, often without effective therapeutic alternatives, especially in the areas of rare diseases, immunological diseases, and hematological malignancies.

This accreditation represents a strategic milestone for Sant Joan de Déu, as it consolidates the institution's position as a leading center in the field of advanced therapies and precision medicine. Furthermore, it will strengthen the center's capacity to develop innovative new treatments, accelerate the translation of research results from the Institut de Recerca Sant Joan de Déu into clinical practice, and reinforce its national and international standing. In this context, the Advanced Therapies Platform will be able to reach 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 its own projects and in collaboration with other centers and institutions.

"Obtaining MIA accreditation represents recognition of the work carried out over the past few years by the entire Advanced Therapies Platform team and reinforces our commitment to developing innovative new therapies for pediatric and adult patients with serious illnesses," emphasizes Alessandra Magnani, head of the Advanced Therapies Platform.

Magnani also underlines that "this accreditation will allow us to expand our production capabilities in the academic field and complement the activity of the pharmaceutical industry, since our therapies are geared towards compassionate use and the development of advanced therapy medicinal products. Furthermore, it will facilitate the establishment of new collaborations with research groups, hospitals, companies, and institutions, both nationally and internationally."

Regulatory Standards

This accreditation confirms that the platform meets the established requirements to guarantee the quality, traceability, and safety of production processes-essential aspects for ensuring that the treatments developed comply with the regulatory standards necessary for their clinical application. All of this is crucial for promoting academic clinical trials and facilitating the delivery of new treatments to patients.

In short, with MIA accreditation, the Advanced Therapies Platform at Sant Joan de Déu takes a significant leap forward in its impact: it moves from producing medicines for its own patients to becoming a leading manufacturing hub for hospitals, research groups, and pharmaceutical companies across Europe. This step reinforces the Hospital's role as a bridge between academic research and clinical practice, and expands access to advanced therapies for patients with diseases that currently lack effective treatment options.

About the Sant Joan de Déu Advanced Therapies Platform

The Sant Joan de Déu Advanced Therapies Platform is a specialized infrastructure dedicated to the development, production, and validation of advanced therapy medicinal products. The platform, which consists of four cleanrooms with a total area of ​​1,280 m², supports translational research projects and clinical trials led by researchers from the Institut de Recerca Sant Joan de Déu and healthcare professionals from the SJD Barcelona Children's Hospital, with the aim of accelerating the delivery of innovative new therapies to patients.