Experience in production of 68Ga-DOTA-NOC for clinical use under an Expanded Access IND

Abstract

MBq, and administered peptide mass averaged 43.2 ± 5.2 µg (n = 47) and 23.9 ± 5.7 µg (n = 127), respectively, using the EZAG and ITG generators. At dose expiration, 68 Ge breakthrough in the final product averaged 2.7 x 10 -7 % and 5.4 x 10 -5 % using the EZAG and ITG generators, respectively.

[68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison with [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting with Biochemical Recurrence

“…The chromatographic determination of radiochemical purity employed ITLC-SG strips developed with 1:1 MeOH:1M NH 4 OH to quantify the level of colloidal 68 Gahydroxide plus ionic 68 Ga, both of which remain at or near the origin while the [ 68 Ga]Ga-P16-093 product migrates near the solvent front. Retrospective analysis of each production batch included testing to verify product sterility and measurement of 68 Ge breakthrough levels in the final product [16,17].…”

Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer

“…The [ 68 Ga]Ga-HBED-CC (PSMA-11) radiopharmaceutical was prepared using 68 Ga from ITG Isotope Technologies Garching GmbH 68 Ge/ 68 Ga generators (30-mCi; 1.11 GBq). Briefly, the 4.0-mL 0.05M ultrapure HCl generator eluate was buffered to pH ~4.8 by addition of ultrapure NaOAc and reacted with the HBED-CC conjugate (10-µg) with heating at ~95°C for 5-minutes employing ITG's manually controlled iQS ® Ga-68 Fluidic Labeling Module [5][6][7][8]. The complete synthetic protocol was as we have described for [ 68 Ga]Ga-DOTA-NOC, with the exceptions of using only a 5-minute reaction time, and the substitution of HBED-CC (PSMA-11) for DOTA-NOC [5].…”

“…The ITLC determination of radiochemical purity employed ITLC-SG strips developed with 1:1 MeOH:1M NH 4 OAc to quantify colloidal 68 Ga-hydroxide plus ionic 68 Ga, both of which remain at or near the origin while the [ 68 Ga]Ga-HBED-CC product migrates near the solvent front. Retrospective analysis of each production batch 5 included sterility testing, and measurement of 68 Ge breakthrough levels in the final product [5].…”