Tracers / [68Ga]Ga-ABY-025

[68Ga]Ga-ABY-025

Also written as [68Ga]Ga-ABY-025; [68Ga]Ga-ABY-025/PET; [Ga-68]Ga-ABY-025; [Ga-68]Ga-ABY-025/PET
Radionuclide
Ga-68 t½ 67.71 min
Modality
PET
Production route
—
Stage
—
Syntheses indexed
2
Breast cancerReceptor expression phenotyping

What it is

Compound class
Radiolabelled affibody molecule (engineered Z-domain scaffold protein, ~7 kDa)
Target / mechanism
Human epidermal growth factor receptor 2 (HER2) PMID 26877784
Clinical application
Whole-body quantification of HER2 expression in metastatic breast cancer PMID 26877784
Theranostic pair
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Regulatory status

FDA
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EMA (centralised)
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Other approvals
—
Brand names
—

Clinical use

Typical injected activity
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Uptake time
—

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
Modular-Lab PharmTracer———98.7 ± 0.6%ABY-02530911434
2019 Am J Nucl Med Mol Imaging
implemented on the Modular-Lab PharmTrace synthesis platform (Eckert & Ziegler)
Modular-Lab PharmTracer
Eckert & Ziegler
vendor cassetteSPE44 ± 2%
yes
98 ± 1%ABY-025 (ZHER2:2891-Cys-MMA-DOTA)
Affibody AB
37991639
2023 EJNMMI Radiopharm Chem
[68Ga]Ga-ABY-025 was produced on a synthesis module, Modular-Lab PharmTracer (Eckert & Ziegler) — With a decay corrected radiochemical yield of 44 ± 2%

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
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USP monograph
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AppearancepHRCP HPLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activityMetal impuritiesGe-68 breakthrough
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator production assumed (no synthesis data found) -> Ge-68 breakthrough (preliminary); receptor ligand with a saturable target -> molar activity (rule)

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Added from reverse module search (stage 6); 2 article(s) with Ga-68.