QC performance of a 62Zn/62Cu microgenerator system for use in PET imaging

377 Objectives: Proportional Technologies (PTI) has developed a 62Cu (T1/2 = 9.7 min.) microgenerator system for use in PET imaging. In order to certify adherence to GMP conditions, performance reliability of the microgenerator system has been validated using a variety of physical measurements. Methods: Over 50 generators have been produced at PTI under GMP conditions and shipped via overnight courier for external studies. A battery of quality control measurements are performed at PTI prior to microgenerator shipment, including the following: establish 62Cu radiochemical identity and absence of excessive contaminant radioisotopes (e.g., 62Zn, 65Zn, 64Cu, 58Co), determine microgenerator specific activity, elution volume, radiochemical yield, and fractional 62Zn breakthrough. The microgenerator eluant is combined with kit-based bis(thiosemicarbazone) ligands for patient dosing. 62Cu labeling yield and solution pH are determined using these kits to validate adherence to release specifications. USP sterility and pyrogenicity tests are performed on the generator eluant just prior to shipment. Results: Highly reliable quality performance of the microgenerator system has been consistently demonstrated. 62Cu radiochemical yields are in excess of 70%, and fractional 62Zn breakthrough is routinely 95%. Of the >85 microgenerators manufactured at PTI for clinical, consumer, and internal use, all have successfully demonstrated negative sterility and pyrogenicity tests. Conclusions: The PTI 62Zn/62Cu microgenerator system’s performance is consistent with that expected for GMP production and is amenable to future commercialization.