Robust high-yield ~1 TBq production of cyclotron based sodium [99mTc]pertechnetate

J D Andersson; B Thomas; S V Selivanova; E Berthelette; J S Wilson; A J B McEwan; K Gagnon

doi:10.1016/j.nucmedbio.2018.02.003

Robust high-yield ~1 TBq production of cyclotron based sodium [^99mTc]pertechnetate

Nucl Med Biol. 2018 May:60:63-70. doi: 10.1016/j.nucmedbio.2018.02.003. Epub 2018 Mar 2.

Authors

J D Andersson¹, B Thomas², S V Selivanova³, E Berthelette³, J S Wilson², A J B McEwan², K Gagnon²

Affiliations

¹ University of Alberta, Medical Isotope and Cyclotron Facility, Department of Oncology, Edmonton, AB, Canada. Electronic address: janderss@ualberta.ca.
² University of Alberta, Medical Isotope and Cyclotron Facility, Department of Oncology, Edmonton, AB, Canada.
³ Sherbrooke Molecular Imaging Center, Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS), Sherbrooke, QC, Canada.

PMID: 29571068
DOI: 10.1016/j.nucmedbio.2018.02.003

Abstract

This paper presents the irradiation and processing of high-current ¹⁰⁰Mo targets at the University of Alberta (UofA) in a GMP compliant setting. For purpose of comparison with a second production facility, additional studies at Centre Hospitalier Universitaire de Sherbrooke (CHUS) are also described.

Introduction: More than 70% of today's diagnostic radiopharmaceuticals are based on ^99mTc, however the conventional supply chain for obtaining ^99mTc is fragile. The aim of this work was to demonstrate reliable high yield production and processing of ^99mTc with medium-energy, high-current, cyclotrons.

Methods: We used two cyclotrons (TR-24, Advanced Cyclotron Systems, Inc) for irradiations with 22 MeV or 24 MeV incident energy and 400 μA current up to a maximum of 6 h. The irradiated ¹⁰⁰Mo was dissolved using peroxide, basified using ammonium carbonate, and purified using a PEG-based solid phase extraction technique.

Results: High-yield productions with 22 MeV (400 μA, 6 h) yielded an average isolated [^99mTc]TcO₄^- yield of 878 GBq ± 99 GBq (23.7 Ci ± 2.7 Ci) decay corrected to EOB, n = 8 (isolated saturation yield: 4.36 ± 0.49 GBq/μA). Irradiations with 24 MeV (400 μA, 6 h) resulted in an average isolated [^99mTc]TcO₄^- yield of 993 GBq ± 100 GBq (26.8 Ci ± 2.7 Ci) decay corrected to EOB, n = 7 (isolated saturation yield: 4.97 ± 0.50 GBq/μA). These yields corresponds to 600-700 GBq (16-19 Ci) of [^99mTc]TcO₄^- at release (i.e. 3 hour post-EOB). For all tested batches, the QC results were within the recently published specifications in the European Pharmacopoeia.

Conclusion: Reliable near-TBq production yields for ^99mTc can be obtained using medium-energy cyclotrons.

Advances in knowledge and implications for patient care: This work presents evidence that medium-energy high-current cyclotrons can provide high yields of [^99mTc]TcO₄^- with radionuclidic impurities levels within the specifications of the existing European Pharmacopoeia monograph, indicating that this technology can have a share in the future ^99mTc supply market.

Keywords: Cyclotron; GMP; High yield; High-current targets; Solid target; [(99m)Tc]pertechnetate.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Cyclotrons*
Endotoxins / analysis
Radiochemistry / instrumentation*
Sodium Pertechnetate Tc 99m / chemistry*

Substances

Endotoxins
Sodium Pertechnetate Tc 99m