Overview and perspectives on automation strategies in 68Ga radiopharmaceutical preparations

Abstract

The renaissance of 68Ga radiopharmacy has led to great advances in automation technology. The availability of a highly efficient, reliable, long-lived 68Ge/68Ga generator system along with a well-established coordination chemistry based on bifunctional chelating agents have been the bases of this development in 68Ga radiopharmacy. Syntheses of 68Ga 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 post-processing of the 68Ga 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 such as current Good Manufacturing Practices (cGMP) and local regulations, some regulatory issues and the more relevant qualification protocols are also discussed. © 2013 Springer-Verlag Berlin Heidelberg.