Sep pak c 18 light

The production of [⁶⁸Ga]PSMA-11 was done with an automatic synthesizer module with disposable cassettes (FASTlab developer, GE Healthcare) in a class C facility. Elution of ⁶⁸GaCl₃ from the ⁶⁸Ge/⁶⁸Ga generator (GalliaPharm, Eckert & Ziegler) was included as the first step of the production process, performed by the FASTlab. The whole eluate volume from the generator was passed through a solid phase cation extraction column, trapping the ⁶⁸Ga³⁺. After washing, the trapped ⁶⁸Ga³⁺ was eluted with 500 μL of a NaCl mixture and mixed with the precursor peptide HBED-CC-PSMA-11, dissolved in ammonium acetate buffer (pH 4.6). Binding of ⁶⁸Ga with the HBED chelate in the precursor HBED-CC-PSMA-11 was performed by heating at 100 °C [17 (link)]. The product, [⁶⁸Ga]PSMA-11, was purified using a reversed-phase solid phase extraction cartridge (Sep-Pak C-18 light, Waters), washed with water and eluted with 50% ethanol, buffered with sterile phosphate buffer (pH 7.4), and delivered through a sterile filter (0.2 μm) to the product vial. All productions passed quality control, where radiochemical purity, amount of peptide, and free ⁶⁸Ga³⁺ were checked with high-performance liquid chromatography. Colloidal ⁶⁸Ga was analyzed with thin-layer chromatography, and residual solvents were checked using gas chromatography.