Production and Quality Control of [68Ga]Ga-FAPI-46: Development of an Investigational Medicinal Product Dossier for a Bicentric Clinical Trial
Rattachement africain : it. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Background/Objectives: Fibroblast activation protein (FAP) is highly expressed in tumor stroma and selected inflammatory conditions, offering a promising target for molecular imaging. [68Ga]Ga-FAPI-46 is a DOTA-based FAP inhibitor with excellent tumor-to-background ratio and potential advantages over [18F]FDG in low-glycolytic tumors. This article aims to highlight the quality elements that are relevant to clinical practice and to describe the development of an investigational medicinal product dossier for a bicentric clinical trial involving [68Ga]Ga-FAPI-46. Methods: The radiolabeling was performed by the two facilities using different automated synthesizers, but with the same specifications and acceptance criteria Results: Three validation batches per site were analyzed for radiochemical/radionuclidic purity, pH, endotoxin, sterility, and bioburden according to European Pharmacopoeia standards. Stability was as sessed up to 2 h post-synthesis. All batches met predefined acceptance criteria. Conclusions: Despite differences in radiosynthesizer modules, product quality and process reproducibility were maintained across both centers. [68Ga]Ga-FAPI-46 can be reliably produced in academic settings under GMP-like conditions, enabling multicenter clinical research and facilitating IMPD submissions for broader adoption of FAP-targeted PET imaging.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Production and Quality Control of [68Ga]Ga-FAPI-46: Development of an Investigational Medicinal Product Dossier for a Bicentric Clinical Trial
- Date Crossref
- 30/09/2025
- Éditeur
- MDPI AG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori pays non établi dans la noticeStructure de recherche
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Istituti di Ricovero e Cura a Carattere Scientifico pays non établi dans la noticeÉtablissement de santé
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University of Bologna Department for Life Quality Studies pays non établi dans la noticeUniversité ou école supérieure
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Ospedale di Prato Santo Stefano pays non établi dans la noticeÉtablissement de santé
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Azienda Usl Toscana Centro Nuovo Ospedale Santo Stefano pays non établi dans la noticeÉtablissement de santé
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IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” IRST pays non établi dans la noticeInstitution
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IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST pays non établi dans la noticeInstitution
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituti di Ricovero e Cura a Carattere Scientifico et Department for Life Quality Studies — University of Bologna, avec 4 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.