Written on 07 February 2024.
Thanks to the positive conclusion of the authorization process of the Italian Medicines Agency AIFA, which ended in October 2023 following an inspection visit by experts from the national regulatory body, theImmuno-Gene Therapy Factory (IGTF) IRST has been authorized, the only one to date in Emilia-Romagna, also for the production of genetically modified T lymphocytes, the so-called CAR-T therapies.
The authorization recognizes IRST’s professionalism, skills, procedures and infrastructures necessary to be able to carry out these therapeutic treatments in total safety and their distribution to hospital centers that can carry out the infusion to patients.
CAR-Ts are at the center of attention due to the excellent results obtained mainly in the treatment of leukemia. It is a therapy based on a type of white blood cell, T lymphocytes, responsible for the body’s defense. The reactivation of T lymphocytes is a treatment that can be obtained through various medical technologies, including their gene engineering: these cells are extracted from the patient, reactivated against the tumor, then reinfused to restore the patient’s immunity.
The AIFA authorization thus extends the production lines of the IGTF IRST Workshop which, in addition to cell therapies, can now also include gene therapies. In fact, since 2012, IRST has already created and administered advanced cell therapies with dendritic cells, used in various experimental clinical protocols including those against melanoma and glioblastoma.
The new goal enhances the coordination of IRST with Emilia Romagna region and active collaborations.
The study, testing and production phases of CAR-T and other genetically modified cellular treatments will be developed in the second IGTF workshop, recently implemented with significant investments from the Institute and funding from the Hub Life Science – Advanced Therapy Project of the Ministry of Health as part of the National Plan for Complementary Investments to the PNRR – Innovative Health Ecosystem. The economic effort of the territory is also important, in particular of the Romagna Oncology Institute – IOR, thanks to which some of the instruments necessary for the automated manipulation and engineering of immune cells were purchased.
The Immuno-Gene Therapy Factory directed by Dr. Massimiliano Petrini (Qualified Person) sees the involvement of 9 highly specialized professional figures divided into production operators (directed by Dr. Anna Maria Granato, Production manager) and Quality Control operators (directed by Dr. Elena Pancisi, QC manager ). The IGTF works in close collaboration with the Somatic Cellular Therapies for Solid Tumors Structure (headed by Dr. Laura Ridolfi).
“The hope – comments Dr. Massimiliano PetriniImmuno-Gene Therapy Factory (IGTF) – is to be able to offer new and promising cellular products to patients, always in the context of clinical trials, and thus to be a reference center in this sector at a national and international level. Due to the complexity of both planning and management, there are very few structures similar to ours in Italy. Such results are only achieved when there is unity of purpose and great teamwork; therefore I cannot help but thank all the managements of the Institute, the Technical Office, the Biomedical Technologies, the Superintendency and all the people who work alongside me, who often put their personal and professional needs in the background to provide opportunities for unique treatments for our patients.”
Great satisfaction on the part of the Institute’s management. The Dr. Lorenzo Stefano MaffioliGeneral Director, underlines: “CAR-Ts are also giving promising results for solid tumors, as well as hematological ones, representing a further frontier of research”.
“It’s a great achievement – adds the professor. Giovanni MartinelliScientific director – We are crowning a six-year effort and we are proud to be part of the great national project to create a network of workshops for advanced therapies. We are committed to sharing our know-how with the regional centers and other IRCCS in the area and in Italy with which we have started collaborations that will bring the best cellular and gene treatments for cancer patients to our Institute”.
The Health Director, Dr Maria Teresa Montella highlights that “this production is for the benefit of all citizens and onco-haematological structures of the Emilia-Romagna region with a view to synergistic and integrated network work and this model encourages the sharing of knowledge and innovations”.