Regulatory Requirements for PET Radiopharmaceuticals Production: Is Automation an Answer?

Positron Emission Tomography (PET) radiopharmaceuticals development has been experiencing explosive growth due to advances in functional imaging technology and exploration of molecular imaging targets for diagnosis and therapy. There are unique operational and safety requirements of PET radiotracer synthesis when compared to drug synthesis in general. In particular, strict sterility and pyrogenicity requirements, batch-to-batch reproducibility, yield, purity, specific activity, fast synthesis time (<2 or 3 T1/2), and radiation protection are defined. The FDA Center of Drug Evaluation and Research (CDER) mandate such requirements for human injection- a distinction between a radiochemical and a radiopharmaceutical. PC-controlled automation of synthetic process is essential for the widespread use of clinical PET providing an essential tool to complying with all aspects of necessary FDA requirements through current good manufacturing practice (cGMP) of human grade radiopharmaceuticals. The FDA regulates automated synthesizers as manufacturing equipment rather than as traditional medical devices.