Optimization of aseptic production in PET radiopharmaceuticals for compliance to the most current GMP

Abstract

The promising outlooks of PET radiopharmaceuticals in molecular imaging result in a need for their production in industrial environments, which otherwise would not be possible to achieve in clinical settings. In keeping with this notion, manufacture of PET radiopharmaceuticals has taken steps toward mainstream pharmaceutical industry. Hence, small-scale radiolabeling performed by experienced chemists in radiochemistry laboratories or small batch production for a few patients in clinical trials is no longer a common practice. This chapter describes issues of the most current GMP that are most unfamiliar to traditional PET radiopharmaceutical production and provides a few examples on how these could be optimized.