GMP-Automated Purification of Copper-61 Produced in Cyclotron Liquid Targets: Methodological Aspects

Author(s): Alexandra I. Fonseca, Vítor H. Alves, Sérgio J. C. do Carmo, Amílcar Falcão, Antero J. Abrunhosa, Francisco Alves*

Journal Name: Current Radiopharmaceuticals

Volume 14 , Issue 4 , 2021


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Abstract:

Background: Expanding the range of metal-based PET radiopharmaceuticals that can be produced by the widely available network of biomedical cyclotrons is a major priority. Copper- 61 is a positron emitter with very favourable physical (61.5% β+, 1.22 MeV max.) and chemical properties, which emerged as a promising PET imaging agent.

Objectives: This work aimed to develop and optimise a GMP-automated purification method for copper-61 produced in a cyclotron using a natural zinc liquid target.

Methods: The automated purification process was performed using a commercially available Synthera ® Extension module (IBA, Louvain-la-Neuve, Belgium) using a three-column method: two extraction chromatographic resins and a strong anion exchange resin. The final product was evaluated using HPGe and ICP-MS analysis, to assess the radionuclidic and chemical purity of the final copper- 61 solution.

Results: The automated purification process was completed within 1 h of processing time, with an average yield of 63.0 ± 15.0%, in a maximum volume of 5 mL. The radionuclidic purity of copper- 61 in the final solution was over 95% for 7 h after EOB. ICP-MS analysis revealed 4.8 ± 2.4 μg of natural zinc in the final purified sample, and the copper-61 molar activity was 230.5 ± 139.3 GBq/μmol.

Conclusion: The described purification process allows for the production of a highly radionuclidically and chemically pure, GMP compliant copper-61 solution, ready to be used for the development of copper-61 based radiopharmaceuticals for routine clinical use.

Keywords: Liquid targets, radiometals, purification, copper-61, PET, molar activity, metal analysis.

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Article Details

VOLUME: 14
ISSUE: 4
Year: 2021
Page: [420 - 428]
Pages: 9
DOI: 10.2174/1874471013666201112141844
Price: $95

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