Automated preparation of clinical grade [⁶⁸Ga]Ga-DOTA-CP04, a cholecystokinin-2 receptor agonist, using iPHASE MultiSyn synthesis platform

Background

Gallium-68 ([⁶⁸Ga]Ga) labelled radiopharmaceuticals have become a valuable tool in clinical practice using Positron Emission Tomography (PET). These agents are typically produced on-site owing to the short half-life of [⁶⁸Ga]Ga (68 min), which hinders distant transportation and often cannot comply with Good Manufacturing Practice (GMP) in hospital environments due to limited resources or infrastructure constraints. Moreover, full blown GMP production of radiopharmaceuticals under development can be prohibitively expensive. [⁶⁸Ga]Ga-DOTA-CP04 is a promising peptide for imaging neuroendocrine tumors overexpressing the cholecyctokinin-2 receptor. Automation is an integral process in ensuring the radiopharmaceuticals produced under non-GMP conditions are of a uniform quality for routine clinical use. Herein, we describe the development of an automation platform, the iPHASE MultiSyn radiosynthesizer, to produce ⁶⁸Ga-labelled DOTA-CP04 for routine clinical provision.

Results

The use of the MultiSyn module for ⁶⁸Ga-labelling of DOTA-CP04 was investigated. [⁶⁸Ga]Ga-DOTA-CP04, was reproducibly prepared in high (> 70%) decay-corrected yields. [⁶⁸Ga]Ga-DOTA-CP04 passed all predetermined acceptance criteria for human injection.

Conclusions

[⁶⁸Ga]Ga-DOTA-CP04 was produced effectively using the MultiSyn module in a consistent and reproducible manner suitable for human injection.