Please use this identifier to cite or link to this item:
https://hdl.handle.net/10316/111786
DC Field | Value | Language |
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dc.contributor.author | Fonseca, Alexandra I. | - |
dc.contributor.author | Alves, Vítor H. | - |
dc.contributor.author | Hrynchak, Ivanna | - |
dc.contributor.author | Alves, Francisco | - |
dc.date.accessioned | 2024-01-10T09:38:00Z | - |
dc.date.available | 2024-01-10T09:38:00Z | - |
dc.date.issued | 2023-10-12 | - |
dc.identifier.issn | 1422-0067 | - |
dc.identifier.uri | https://hdl.handle.net/10316/111786 | - |
dc.description.abstract | 68Ga-based radiopharmaceuticals are routinely used for PET imaging of multiple types of tumors. Gallium-68 is commonly obtained from 68Ge/68Ga generators, which are limited in the quantity of activity produced. Alternatively, gallium-68 can easily be produced on a cyclotron using liquid targets. In this study, we optimized the GMP production of [68Ga]GaFAPI-46 using gallium-68 produced via a standard medical cyclotron using liquid targets. Starting from the published synthesis and quality control procedures described for other 68Ga-based radiopharmaceuticals, we have validated the synthesis process and the analytical methods to test the quality parameters of the final product to be used for routine clinical studies. [68Ga]GaFAPI-46 was successfully produced with high radiochemical purity and yield using an IBA Synthera® Extension module. Gallium chloride was produced on a medical cyclotron using a liquid target with activity of 4.31 ± 0.36 GBq at the end of purification (EOP). Analytical methods were established and validated, meeting Ph. Eur. standards. Full GMP production was also validated in three consecutive batches, producing 2.50 ± 0.46 GBq of [68Ga]GaFAPI-46 at the end of synthesis (EOS), with 98.94 ± 0.72% radiochemical purity measured via radio-HPLC. Quality was maintained for up to 3 h after the EOS. Production of [68Ga]GaFAPI-46 was performed and validated using a standard medical cyclotron with liquid targets. The quality control parameters (e.g., sterility, purity, and residual solvents) conformed to Ph. Eur. and a shelf life of 3 h was established. The activity of [68Ga]GaFAPI-46 produced was substantially higher than the one obtained with generators, enabling a better response to the clinical need for this radiopharmaceutical. | pt |
dc.language.iso | eng | pt |
dc.publisher | MDPI | pt |
dc.relation | PD/BDE/150681/2020 | pt |
dc.relation | PD/BDE/150331/2019 | pt |
dc.relation | ICNAS-P. | pt |
dc.rights | openAccess | pt |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | pt |
dc.subject | radiopharmaceuticals | pt |
dc.subject | cyclotron | pt |
dc.subject | liquid targets | pt |
dc.subject | GaFAPI-46 | pt |
dc.title | Fully Automated Production of [68Ga]GaFAPI-46 with Gallium-68 from Cyclotron Using Liquid Targets | pt |
dc.type | article | pt |
degois.publication.firstPage | 15101 | pt |
degois.publication.issue | 20 | pt |
degois.publication.title | International Journal of Molecular Sciences | pt |
dc.peerreviewed | yes | pt |
dc.identifier.doi | 10.3390/ijms242015101 | - |
degois.publication.volume | 24 | pt |
dc.date.embargo | 2023-10-12 | * |
dc.identifier.pmid | 37894781 | - |
uc.date.periodoEmbargo | 0 | pt |
dc.identifier.eissn | 1422-0067 | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | open | - |
item.openairetype | article | - |
item.languageiso639-1 | en | - |
item.fulltext | Com Texto completo | - |
item.cerifentitytype | Publications | - |
crisitem.author.researchunit | ICNAS - Institute for Nuclear Sciences Applied to Health | - |
crisitem.author.orcid | 0000-0002-1671-7861 | - |
crisitem.author.orcid | 0000-0001-8054-4267 | - |
Appears in Collections: | I&D CIBIT - Artigos em Revistas Internacionais I&D ICNAS - Artigos em Revistas Internacionais |
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File | Description | Size | Format | |
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Fully-Automated-Production-of-sup68supGaGaFAPI46-with-Gallium68-from-Cyclotron-Using-Liquid-TargetsInternational-Journal-of-Molecular-Sciences.pdf | 1.38 MB | Adobe PDF | View/Open |
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This item is licensed under a Creative Commons License