Advanced Therapies Unit

The Unit has highly trained and qualified personnel for the production of advanced therapies. These services are primarily carried out in the cellular clean room facilities of the Institute. All production is performed in accordance with Good Manufacturing Practices (GMP) and complying with the Spanish control authority (AEMPS).

This Unit has a 39 m² clean room infrastructure and provides validation and manufacturing services for Advanced Therapy Medicinal Products (ATMP) and their compliance with Good Manufacturing Practices (GMP) according to the guidelines set by the AEMPS (Spanish Agency of Medicines) from an academic/hospital environment. Additionally, the IR Sant Pau facility is authorized by the Ministry for the Ecological Transition (National Biosafety Commission) for the contained use of genetically modified organisms (GMOs) with code A/ES/19/I-09.

All GMP procedures for CAR-T cells (ATMP) are performed in the Institute’s clean room using CliniMACS Prodigy® (Miltenyi Biotech) automated cell processing devices, which offer a flexible and closed system for cell processing applications, from cell separation through cell culture to the formulation of the final product.

Since July 2020, we have been authorized by the AEMPS as manufacturers of 2 CAR T cells (HSP-CAR30 and HSP-CAR19M) for the treatment of Oncohematological Diseases in a phase I/II clinical trial led by the Oncology/Hematology and Transplantation research group. This manufacturing is carried out in close collaboration with the Blood and Tissue Bank (BST) as a co-manufacturer.

Consult the plan of the future Unit by clicking here.