[68Ga]Ga-PentixaFor: Development of a fully automated in hospital production on the Trasis miniAllinOne synthesizer.
Details
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State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_4BB14CB005A2
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
[68Ga]Ga-PentixaFor: Development of a fully automated in hospital production on the Trasis miniAllinOne synthesizer.
Journal
Journal of labelled compounds & radiopharmaceuticals
ISSN
1099-1344 (Electronic)
ISSN-L
0362-4803
Publication state
Published
Issued date
10/2023
Peer-reviewed
Oui
Volume
66
Number
12
Pages
400-410
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
[ <sup>68</sup> Ga]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. [ <sup>68</sup> Ga]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 [ <sup>68</sup> Ga]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 environmental monitoring performed during the synthesis process showed that the aseptic conditions were ensured. [ <sup>68</sup> Ga]Ga-PentixaFor was successfully synthesized with the miniAiO by a fully automated process. This robust production mode and the quality control have been validated in this study allowing to increase the access of patients to this new promising radiopharmaceutical.
Keywords
Humans, Coordination Complexes, Peptides, Cyclic, Radiopharmaceuticals, [68Ga]Ga-PentixaFor, automated production, miniAllinOne, quality control, radiopharmaceutical, validation method
Pubmed
Web of science
Open Access
Yes
Create date
25/09/2023 14:57
Last modification date
10/02/2024 7:20