[68Ga]Ga ‐PentixaFor: Development of a fully automated in hospital production on the Trasis miniAllinOne synthesizer

[68Ga]Ga-PentixaFor was conveniently prepared in sterile conditions, with the new fully automated and highly reproducible process we developed on the miniAiO ® synthesizer. The final product conforms with the European Pharmacopeia specifications. This automated production of [68Ga]Ga-PentixaFor and its availability allow to perform clinical studies in our hospital and to increase the access of patients to this new promising radiopharmaceutical. [68Ga]Ga-PentixaFor is a frequently used radiotracer to image the CXCR4/CXCL12 axis in various malignancies, infections, and cardiovascular diseases. To answer increasing clinical needs, an automatized synthesis process ensuring efficient and reproducible production and improving operator's radioprotection is needed. [68Ga]Ga-PentixaFor synthesis has been described on other synthesizers but not on the miniAiO. In this work, we defined automated synthesis process and an analytical method for the quality control of [68Ga]Ga-PentixaFor. Validation batches were performed under aseptic conditions in a class A hotcell. All the quality controls required by the European Pharmacopea (Eur. Ph) were performed. The analytical methods were validated according to the International Conference Harmonization (ICH) recommendations. Validation batches were performed with a radiochemical yield of 94.8  ± 2.6%. All the quality controls were in conformity with the Eur. Ph, and the validation of the analytical method complied with the ICH. The environm...
Source: Journal of Labelled Compounds and Radiopharmaceuticals - Category: Biochemistry Authors: Tags: RESEARCH ARTICLE Source Type: research