WP 1.8 – Synthesis and production of tumor-targeted Radionuclides, Radiotracers and Radiopharmaceuticals for clinical use

Partners involved: CNR-IFC, CNR-IN, UNIFI, UNIPI

Coordinators: Michela POLI (CNR-IFC), Duccio VOLTERRANI (UNIPI)

Outline: The general objective of sub-project 8 is to make available radiopharmaceuticals for oncological diagnostics to THE for clinical applications. The radiopharmaceuticals will be produced in the “Officina Farmaceutica” (OF) of CNR-IFC in Pisa, the only one Italian site of a public institution authorized by AIFA to produce radiopharmaceuticals according to GMP (Good Manufacturing Practice). The organization chart reflects the regulation 219/06 for pharmaceutical preparations. Two “Qualified Persons” have been authorized by AIFA to release drugs for human use. OF already produces some authorized radiopharmaceuticals for specific companies and tightly collaborates with Toscana Gabriele Monasterio Foundation for production and testing of new radiopharmaceuticals to be used in pre-clinical and clinical studies of phase 1, 2 and 3.