Ga Radiopharmaceutical Preparations

The renaissance of Ga radiopharmacy has led to great advances in automation technology. The availability of a highly efficient, reliable, long-lived Ge/Ga generator system along with a well-established coordination chemistry based on bifunctional chelating agents have been the bases of this development in Ga radiopharmacy. Syntheses of Ga peptides were originally performed by manual or semiautomated systems, but increasing clinical demand, radioprotection, and regulatory issues have driven extensive automation of their production process. Several automated systems, based on different postprocessing of the Ga generator eluate, on different engineering, and on fixed tubing or disposable cassette approaches, have been developed and are discussed in this chapter. Since automatic systems for preparation of radiopharmaceuticals should comply with qualification and validation protocols established by regulations current Good Manufacturing Practices (cGMP) and local regulations, some regulatory issues and the more relevant qualification protocols are also discussed. S. Boschi (&) C. Malizia F. Lodi PET Radiopharmacy, Nuclear Medicine Department, S.Orsola-Malpighi University Hospital, Bologna, Italy e-mail: [email protected] S. Boschi Radiofarmacia PET, U.O. Medicina Nucleare, Pad.30 Polo Tecnologico, Azienda Ospedaliero Universitaria S.Orsola-Malpighi, Via Massarenti 9, 40138 Bologna, Italy R. P. Baum and F. Rösch (eds.), Theranostics, Gallium-68, and Other Radionuclides, Recent Results in Cancer Research 194, DOI: 10.1007/978-3-642-27994-2_2, Springer-Verlag Berlin Heidelberg 2013 17