The Sant Pau Research Institute celebrated today the laying of the cornerstone of its new Advanced Therapies Unit. These new facilities, supported by the Josep Carreras Leukaemia Research Institute and the Josep Carreras Foundation against Leukaemia, solidify themselves as a strategic resource for the Sant Pau Campus. They enable the development and manufacturing of personalized biological medicines within the hospital center for the treatment of its patients, reaffirming Sant Pau’s position as a global reference center in this field.
The event was attended by various figures from the sector, including Acting Counselor Manel Balcells; the Director of the Sant Pau Research Institute, Dr. Jordi Surrallés; the President of the Executive Committee of the Josep Carreras Leukaemia Research Institute, Dr. Evarist Feliu; the Director of the Hematologic Oncology and Transplantation Research Group at the Sant Pau Research Institute and Director of the Hematology Service at Sant Pau Hospital, Dr. Javier Briones; and the Director of Sant Pau Hospital, Dr. Adrià Comella.
The project involves a total investment of 5.5 million euros over the next 4 years for the construction, launch, and operation of this new infrastructure, made possible through collaboration with the Josep Carreras Leukaemia Research Institute and the contribution of the Josep Carreras Foundation against Leukaemia. This foundation has contributed over 4.5 million euros, establishing the Josep Carreras Campus within Sant Pau, aimed at conducting scientific research activities related to leukemia, other hematologic malignancies, cancer in general, and particularly in immunotherapy, oncogenesis, cellular therapy, and other related areas.
Furthermore, the new Sant Pau Advanced Therapies Unit is supported by the Blood and Tissue Bank (BST), which provides professional expertise and manufacturing capacity for advanced therapy medicines as part of a recently signed collaboration agreement aimed at boosting the development and production of innovative medicines.
Dr. Jordi Surrallés, Director of the Sant Pau Research Institute, highlights that the new facilities will enhance the important work of research groups focused on developing new advanced therapies, such as those led by Dr. Briones in the field of hematology. “This new infrastructure positions us at the forefront of research in this field and will help us advance more rapidly towards more effective and personalized treatments for our patients, while continuing to contribute to the advancement of scientific knowledge.”
Moreover, the new unit will pave the way for the creation of additional research lines in various fields, aimed at developing therapies for other currently incurable pathologies using advanced techniques, facilitating highly personalized and precise medicine.
“This infrastructure is an asset that can serve not only other research centers in Catalonia and Spain but also opens the door to establishing international collaborations with centers worldwide for the benefit of many patients and the advancement of knowledge in this area,” adds Dr. Surrallés.
The facilities will expand from 39 m² – the current clean room area at Sant Pau – to a total of 163 m², multiplying the production capacity of CAR-T products. The new unit is designed to meet the strictest quality and safety criteria established by regulatory agencies, allowing the manipulation of biological products such as genes, cells, and tissues. The infrastructure will include 4 clean rooms for manufacturing with specific cleanliness and containment levels for the production of advanced therapy medicines – one equipped for the production of viral vectors and recombinant viruses – and two laboratories, one for cultures and one for quality control.
Clean rooms are specially designed and controlled spaces for conducting high-precision biomedical research. These facilities enforce rigorous protocols for personal hygiene and equipment and surface cleaning, as well as strict environmental control. Variables such as temperature, humidity, and air pressure are precisely regulated to ensure optimal working conditions. Additionally, air is continuously filtered to remove particles and microorganisms that could interfere with experimental processes.
Dr. Surrallés notes that, in addition to state-of-the-art facilities, “Sant Pau has highly specialized technical personnel who not only ensure compliance with the highest quality standards but also enable us to fully exploit the potential offered by clean rooms.”
“It’s a dream come true. For over 20 years, we’ve been working in immunotherapy, and in the last 10 years, we’ve focused on CAR-T therapies. This new unit will allow us to increase our production capacity and reach more patients, offering personalized treatments for diseases that were previously incurable,” says Dr. Briones.
Sant Pau is one of the two authorized hospitals in Catalonia – and one of the few worldwide – to produce CAR-T immunotherapy drugs. So far, researchers at the Sant Pau Research Institute have developed two academic CAR-T medicines: HSP-CAR30 and HSP-CAR19M. “There are very few centers worldwide that produce their own CAR-T therapies, meaning they have the technology, capacity, expertise, and facilities to develop these therapies,” says Dr. Briones.
The new Sant Pau Advanced Therapies Unit will not only allow for increased medicine production but also centralize the entire development process within the same institution, from producing recombinant viruses to the final manufacturing of medicines. This will ensure greater efficiency and quality control throughout the process. Dr. Briones emphasizes that “the new unit will not only increase our production capacity but also enable us to conduct clinical trials from start to finish, with all the advantages that entails.”
The Cellular Immunotherapy and Gene Therapy Research Group at the Sant Pau Research Institute has developed two academic CAR-T medicines so far: HSP-CAR30 and HSP-CAR19M, with an ambitious project led by Dr. Briones.
HSP-CAR30 is currently in phase II clinical trials and represents Europe’s first CAR-T30 immunotherapy medicine (academic). Phase I trials demonstrated that CAR30 memory T cells (HSP-CAR30) have an excellent safety profile with very low toxicity, along with high efficacy, as 50% of patients achieved a complete response to lymphoma treatment with disappearance of the disease.
“The CART 30 is the first one developed in Europe, with only three more in the world, in the United States and China. Therefore, it is a pride for us to develop these types of therapies and, most importantly, to offer them to our patients. Moreover, as it is currently the only CAR 30 developed in Europe, we also treat patients who come from other countries. This is a pride and a professional enrichment for us, as it gives us the opportunity to generate knowledge,” adds this expert.
HSP-CAR19M offers a therapeutic proposal unique in Spain for patients with certain types of lymphoma (diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma) that have not responded to other treatments, through the generation of memory CART19 cells. Currently, clinical trials are underway, promoted, coordinated, and led from Sant Pau, in collaboration with the Hematology Service of Virgen del Rocío Hospital in Seville, within the Advanced Therapies Network, one of the Health Results-Oriented Cooperative Research Networks (TERAV) promoted by the Carlos III Health Institute (ISCIII). These two major projects have received financial support from multiple institutions such as ISCIII, the Josep Carreras Foundation against Leukaemia, La Caixa Foundation, and the European Union Commission (EU).
The Sant Pau Research Institute is part of the European research project on CART-T therapy (T2Evolve) and is one of the accredited centers in Spain authorized to use CAR-T medicines by the Directorate General for Basic Portfolio of Services of the National Health System and Pharmacy under the Ministry of Health. The Sant Pau Research Institute has state-of-the-art facilities, as well as highly qualified and specialized professionals, enabling the development of unique CAR-T immunotherapy projects in Europe. Moreover, it has been selected as a center for the State Consortium for the Development of Advanced Therapies (CERTERA) by ISCIII, and is a member of the Advanced and Emerging Therapies Network of Catalonia, promoted by the Department of Health of the Generalitat and coordinated by BIOCAT. The Sant Pau Research Institute has a strategic agreement to promote these techniques with the Blood and Tissue Bank, with whom it shares Technical Direction.
The new facility includes 4 manufacturing rooms equipped with defined cleanliness and containment levels for the production of advanced therapy medicines:
3 positive pressure rooms with different levels of environmental cleanliness for manufacturing ATMP in bioreactor (2 rooms) or open systems (1 room).
1 negative pressure (containment) room for manufacturing gene therapy ATMP and generating genetic modification tools (viral vectors).
All new spaces have been designed considering environmental classifications according to EU GMP Part IV, Chapter 4.3.1 Design and Construction.
The ceremony to lay the first stone of its new Sant Pau Advanced Therapies Unit was also attended by the Councilor of the Barcelona City Council, Josep Lluís Franco; the deputy director general of Health Research and Innovation of the Department of Health, Montserrat Llavayol; the manager of Personalized and Precision Medicine of the Ministry of Health, Gemma Valeta; the executive director of the Eixample i Gràcia health sectors, and the Barcelona Dreta Comprehensive Health Area, Luis Espinosa, and the director of the BST, Ana Millán.
Last update: 18 de June de 2024
