The Research Institute of the Hospital de la Santa Creu i Sant Pau – IBB Sant Pau, has successfully undergone the renewal inspection of the certificate of compliance with the Correct Manufacturing Standards for Advanced Therapy Medicines, issued by the Spanish Agency for Medicines and Health Products (AEMPS). With this achivement, it will be able to double its production capacity.
This certification, initially obtained in 2020 in collaboration with the Blood and Tissue Bank of Catalonia, authorizes the production and quality control of CAR-T cellular medicines in the Clean Room, equipment specially designed for the advanced therapy drug development that allows Sant Pau researchers to offer innovative treatments to their patients.
This recognition highlights the work of the research group in Hematology Oncology and Transplantation, where Dr. Javier Briones leads the line of research in cellular immunotherapy and gene therapy, together with the staff of the Clean Room and the Quality Unit of the institute.
Sant Pau is one of the two authorized centers in Catalonia to produce this type of CAR-T immunotherapy medicine. The experience of the institute’s research groups makes it possible to lead and develop translational research projects that, among others, include clinical trials and, therefore, patient treatment. In 2020, the first trial began with a pioneer CAR-T immunotherapy drug in Europe, for the treatment of classic Hodgkin lymphoma and non-Hodgkin T CD30 + lymphoma in relapse or refractory.
In this renewal, the AEMPS authorizes the production of a second advanced therapy drug HSP-CAR19M, a product that is based on T lymphocytes that express a chimeric antigen receptor (CAR) targeting the CD19 molecule. It is currently being investigated for autologous use in the treatment of relapsed or refractory non-Hodgkin B lymphoma in a phase I/II clinical trial at the Hospital de la Santa Creu i Sant Pau.
