Advanced therapy medicinal products (ATMPs) are complex medicines based on gene therapy, somatic cell therapy, and tissue engineering. These products are rapidly arising as novel and promising therapies for a wide range of different clinical applications. ATMPs offer a new powerful opportunity for treating, and in some instances, curing diseases (such as cancer) for which there are often no other available treatments. While this has offered an important new therapeutic tool, it has also raised the need to produce drugs follow¬ing regulations, modalities, and quality standards that ensure safety for patients. In fact, ATMPs are character¬ized by a very different modalities, use different cell types and, mostly, for the different manufacturing protocols. The process for the development of well-established ATMPs is challenging, many issues must be considered from raw material, manufacturing, safety, and pricing to assure the quality of ATMPs and their implementation as innovative therapeutic tools. Following, the ATMPs production is a complex manufac¬turing process and the procedures are still evolving to meet these unique needs. The efficient manufacturing is a critical aspect of determining whether a cell therapy will be utilized in the clinical applications or not.
In the ATMPs scenario, Chimeric Antigen Receptor (CAR) T cells play a fundamental role as they have changed the therapeutic landscape of hematological malignancies with overwhelming success. The clinical success of CAR T-cell therapy in hematologic malignancies has fueled interest in exploring the technology in solid tumors. However, the treatment of solid tumors presents a unique set of challenges compared to hematological tumors. The biggest impediments to the success of CAR T cell treatment are the paucity of tumor-specific antigens that are produced selectively and uniformly and the immunosuppressive tumor microenvironment. To overcome these significant challenges, new strategies were improved for enhancing the efficacy and safety of the CAR-T in the clinical applications for blood and solid malignancies.
23 Maggio 2025