Otto: a 4.04 GBq (109 mCi) 68Ge/68Ga generator, first of its kind - extended quality control and performance evaluation in the clinical production of [68Ga]Ga-PSMA-11.

ABSTRACT: BACKGROUND:Here we report on the comprehensive quality control of a 4.04 GBq (109 mCi) generator supplied by itG (Munich, Germany), and used for routine production of [68Ga]Ga-PSMA-11 for clinical imaging. The performance of the 4.04 GBq itG 68Ge/68Ga generator was studied for a year and parameters including elution yield, elution profile, radioactive and stable contaminants were collected. The production yields of a series of 175 [68Ga]Ga-PSMA-11 clinical batches are also reported herein. RESULTS:This first-of-its-kind GMP grade 68Ge/68Ga generator from itG with a nominal activity of 4.04 GBq (109 mCi) showed a stable 68Ga elution profile with elution efficiency averaging 58.3 ± 3.7%. 68Ge contaminant in the eluent slightly increased over time but remained 100x lower than those reported f

SUBMITTER: Waterhouse NN 

PROVIDER: S-EPMC6997319 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature