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. 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 for comparable 1.85 GBq (50 mCi) itG generators. Metal impurities were found in concentrations lower than 100 ng/ml (ppb) throughout the study. [68Ga]Ga-PSMA-11 was obtained in 89 ± 4% radiochemical yields and > 99% radiochemical and chemical purities. 4.04 GBq (109 mCi) itG 68Ge/68Ga generator is suitable for routinely produced 68Ga tracers used in the clinic. Up to 30% higher amount of final drug product was obtained as compared to the 1.85 GBq (50 mCi) itG generator, and as a result larger number of studies could be performed, while reducing the synthetic burden.

中文翻译：

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奥托（Otto）：4.04 GBq（109 mCi）68Ge / 68Ga发生器，首创–在[68Ga] Ga-PSMA-11的临床生产中扩展的质量控制和性能评估。

在这里，我们报告了由itG（德国慕尼黑）提供的4.04 GBq（109 mCi）发生器的全面质量控制，该发生器用于常规生产用于临床成像的[68Ga] Ga-PSMA-11。对4.04 GBq itG 68Ge / 68Ga发生器的性能进行了一年的研究，并收集了包括洗脱量，洗脱曲线，放射性和稳定污染物在内的参数。本文还报道了一系列175 [68Ga] Ga-PSMA-11临床批次的产量。这是itG同类产品中首款GMP等级68Ge / 68Ga发生器，标称活性为4.04 GBq（109 mCi），显示出稳定的68Ga洗脱曲线，洗脱效率平均为58.3±3.7％。随着时间的流逝，洗脱液中的68Ge污染物略有增加，但仍比报告的同类1.85 GBq（50 mCi）itG发生器低68x。在整个研究过程中发现金属杂质的浓度低于100 ng / ml（ppb）。以89±4％的放射化学产率和> 99％的放射化学和化学纯度获得[68Ga] Ga-PSMA-11。4.04 GBq（109 mCi）itG 68Ge / 68Ga发生器适用于临床上常规生产的68Ga示踪剂。与1.85 GBq（50 mCi）itG生成器相比，最终药物的产量高出30％，因此可以进行更多的研究，同时减少合成负担。