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• W3033209042 abstract "466 Objectives: The increasing demand of 68Ga during the last decade has been a challenge for suppliers of this short-lived radionuclide. Although high production volumes of the 68Ge/68Ga generators have recently been made to meet existing needs, there is a strong commercial appeal for cyclotron-produced 68Ga to overcome limited availability of 68Ga radiopharmaceuticals, particularly in densely populated regions. With these in mind, the focus of this study was to validate our cyclotron-produced 68Ga as an alternative source for compounding radiopharmaceutical kits that can be used in routine clinical practice. Methods: The entirety of 68Ga-chloride production was performed using a commercially available module under a cGMP controlled environment. The 68Ga was produced via irradiation of a 68Zn solid target (enrichment: 99.26%, 20-40 mg) by a medical cyclotron for 90 min, with protons at 14.5 MeV energy and beam current of 40 μA. The irradiated target was dissolved and processed by an automation module fitted with our patented single-column purification system. The purified 68Ga-chloride with activity between 14.8-29.6 GBq (0.4-0.8 Ci) was formulated with 26 mL of 0.1 N HCl and passed through a 0.22 µm filter as the compounding substance. To validate its feasibility to compound a radiopharmaceutical kit, 5 mL of the formulated 68Ga-chloride solution containing activity of 1.48-2.22 GBq (40-60 mCi) was added directly to GalliProst, a commercially available single-dose kit of 68Ga-THP-PSMA provided by Theragnostics Inc. The final radiolabeled product required no further purification and QC was performed under the USP guidelines. Results: The fully-automated process of 68Ga-chloride production takes less than 30 minutes after target irradiation. The radionuclidic purity was ≥ 99.8% at the end of production with 67Ga as the primary radionuclidic impurity found through gamma-ray spectroscopy. ICP-MS analysis of the decayed 68Ga-chloride samples was compared to the 68Ga eluent from both ITG and IGG-100 68Ge/68Ga generators (Table 1), in which the data indicated our cyclotron-produced 68Ga is equal, if not better in quality, compared to its generator-produced counterpart. Additionally, the formulated 68Ga-chloride solution was determined to be sterile and colorless. The TLC analysis of the compounding product (68Ga-THP-PSMA) has consistently reported a radiochemical purity of greater than 95% with the pH of 6.0-7.0, which is comparable to the 68Ga eluent from the 68Ge/68Ga generator as the compounding substance. Conclusions We have developed a reliable and fully automated method for the routine production of 68Ga-chloride that is comparable to its generator-produced counterpart and can be used as an alternative source for compounding radiopharmaceutical kits. Whereas the validation toward other commercially available kits are currently underway, our preliminary results indicate the potential for the future development of radiopharmaceutical kits in multi-dose vials compounding with large scale 68Ga activity." @default.
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• W3033209042 date "2020-05-01" @default.
• W3033209042 modified "2023-09-27" @default.
• W3033209042 title "Validating Cyclotron-Produced 68Ga as an Alternative Source for Compounding Radiopharmaceutical Kits" @default.
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