Development and Evaluation of User-Friendly Single Vial DOTA-Peptide Kit Formulations, Specifically Designed for Radiolabelling with 68Ga from a Tin Dioxide 68Ge/68Ga Generator

Abstract

The single vial kit formulations met the quality release specifications for human administration and appear to be highly advantageous over using peptide stock solutions in terms of stability and user-friendliness.

Production of [68Ga]Ga‐PSMA: Comparing a manual kit‐based method with a module‐based automated synthesis approach

“…Several commercial kits for [ 68 Ga] Ga-PSMA production have been recently introduced in clinical use (e.g., ANMI and THP kits). [6][7][8][9] We also demonstrated previously, by comparing biodistribution obtained using a kit-produced [ 68 Ga]Ga-PSMA with published data of manual synthesis, that no significant differences were present. 9 Automated radiosynthesis modules have gained considerable popularity 6,10 as they allow reduction of radiation exposure for operators, improve production efficiency, and provide an electronic documentation system to facilitate compliance with GMP requirements.…”

“…9 For System B, the labeled product was detected at an R f of 0.75-1.0 and the free gallium-68 species at an R f of 0.05, as described previously. 8 The radio-HPLC method was described previously. 10 Briefly, a reverse-phase HPLC column (Zorbax SB C18, 4.6 mm × 250 mm × 5 μm, Agilent Technologies, Santa Clara, CA, USA) was used at a flow rate of 1 ml/min with a linear A-B gradient (0%-100% B in 6 min).…”

“…Various gallium-68 radiopharmaceuticals have been adapted to cold-kit formulations that allow a less complicated labeling process without the need of an automated system and reduced cost of consumables. [6][7][8][9] The cold-kit contains all the reagents (including buffers, cold precursor and stabilizers) to allow a user-friendly, short and efficient labeling process. If an instant one-step labeling process is available, it will lead to great logistical benefits in the hospital radiopharmacy.…”

“…Utilization of ready‐to‐use vials for gallium‐68 radiopharmaceuticals similar to those used during preparation of technetium‐99m radiopharmaceuticals is a new trend emerging in recent years. Various gallium‐68 radiopharmaceuticals have been adapted to cold‐kit formulations that allow a less complicated labeling process without the need of an automated system and reduced cost of consumables 6–9 . The cold‐kit contains all the reagents (including buffers, cold precursor and stabilizers) to allow a user‐friendly, short and efficient labeling process.…”

The effects of trace metal impurities on Ga-68-radiolabelling with a tris(3-hydroxy-1,6-dimethylpyridin-4-one) (THP) chelator

“…One-step, kit-based radiolabelling protocols that provide a radiopharmaceutical in quantitative radiochemical yield (RCY), and in pyrogen-free, physiologically-compatible solutions are the ideal for 68 Ga radiopharmaceuticals. 4,5 Such kitbased radiosyntheses reduce the need for expensive infrastructure and highly trained personnel. Kit-based radiosynthesis protocols have been used for formulation of 99m Tc radiopharmaceuticals for almost ve decades.…”