Boschi Stefano, Malizia Claudio, Lodi Filippo
Nuclear Medicine Department, S.Orsola-Malpighi University Hospital, Bologna, Italy.
Recent Results Cancer Res. 2013;194:17-31. doi: 10.1007/978-3-642-27994-2_2.
The renaissance of (68)Ga radiopharmacy has led to great advances in automation technology. The availability of a highly efficient, reliable, long-lived (68)Ge/(68)Ga generator system along with a well-established coordination chemistry based on bifunctional chelating agents have been the bases of this development in (68)Ga radiopharmacy. Syntheses of (68)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 post-processing of the (68)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 such as current Good Manufacturing Practices (cGMP) and local regulations, some regulatory issues and the more relevant qualification protocols are also discussed.
（68）镓放射性药物的复兴推动了自动化技术的巨大进步。高效、可靠、长寿命的（68）锗/（68）镓发生器系统的可用性，以及基于双功能螯合剂的成熟配位化学，一直是（68）镓放射性药物这一发展的基础。（68）镓肽的合成最初是通过手动或半自动系统进行的，但不断增长的临床需求、辐射防护和监管问题推动了其生产过程的广泛自动化。基于（68）镓发生器洗脱液的不同后处理、不同工程以及固定管路或一次性盒式方法，已经开发了几种自动化系统，并将在本章中进行讨论。由于放射性药物制备的自动系统应符合现行良好生产规范（cGMP）等法规以及当地法规制定的鉴定和验证方案，因此还将讨论一些监管问题和更相关的鉴定方案。
