Written by: Jordi Gibert, Head of Biotechnology Unit
At Klinea we work to contribute to the democratization of access to new cell therapies. As an example of this commitment, we present one of the most relevant projects in which we have participated during the last year.
New clean rooms for cellular therapies at Hospital Sant Pau
From Klinea, we have designed, directed and supervised the creation of the production facilities of the new Advanced Therapies Unit of the Sant Pau’s Research Institute. This infrastructure will become a strategic resource for the development and manufacture of personalized biological drugs for the treatment of oncohematological patients.
To triple the manufacturing capacity for CAR-T products and other personalized medicines, the Sant Pau hospital facilities have been expanded from 39m2 to a total of 163m2.
The new unit has been designed to meet the strictest quality and safety criteria defined by regulatory agencies, ensuring the safe handling of biological products such as genes, cells and tissues.
The infrastructure includes:
- Four manufacturing clean rooms with specific cleanliness and containment levels for the production of advanced therapies.
- Three positive pressure rooms for the production of advanced therapy drugs (ATDM) in closed automated bioreactors or in open systems.
- A negative pressure biocontainment room for the manufacture of gene therapy MTAs and the production of viral vectors and recombinant viruses.
- Two laboratories, one for cell culture and the other for quality control, are essential to guarantee the safety and efficacy of the treatments.
In addition, the development and manufacture of personalized biologic drugs within the same hospital – the centralization of the entire development process – will ensure greater efficiency and quality control throughout the process and will make it possible to offer personalized treatments for diseases for which there was no cure until now.
Sant Pau is one of the two authorized hospitals in Catalonia, and one of the few in the world, with the capacity to produce CAR-T therapies internally. This positions it as a reference center in the development of innovative treatments. To date, two academic CAR-T drugs have already been developed: HSP-CAR30 and HSP-CAR19M.
This ambitious project has been possible thanks to the financial support of the Josep Carreras Leukemia Foundation, as well as the collaboration with the Josep Carreras Leukemia Research Institute and the support of the Banc de Sang i Teixits (Blood and tissue bank).
This initiative establishes the Sant Pau Campus of the Josep Carreras Leukemia Research Institute, which was created with the aim of carrying out scientific research on cancer, leukemia and other hematological diseases, especially immunotherapy, oncogenesis and cell therapy.
For Klinea, having participated in this project is a real honor. “It has been a pleasure to contribute to the development of biomedical technology and to improve the well-being of all patients who will benefit from the increased availability of these therapies,” says Jordi Gibert, head of Klinea’s Biotechnology Unit.
With these initiatives, we continue to position ourselves as a key player in the development of infrastructures and technologies for the production of advanced therapies, reaffirming our commitment to innovation and progress in the field of healthcare.
