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

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 ±â€¯99 GBq (23.7 Ci ±â€¯2.7 Ci) decay corrected to EOB, n = 8 (isolated saturation yield: 4.36 ±â€¯0.49 GBq/µA). Irradiations with 24 MeV (400 µA, 6 h) resulted in an average isolated [99mTc]TcO4- yield of 993 GBq ±â€¯100 GBq (26.8 Ci ±â€¯2.7 Ci) decay corrected to EOB, n = 7 (isolated saturation yield: 4.97 ±â€¯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.

Separation of [(99m)Tc]pertechnetate and molybdate using polyethylene glycol coated C18 and C30 resins.

Hydrophobic adsorbents such as C18 and C30 were coated with PEG and subsequently used for the separation of Mo/Tc. The most effective resin for adsorbing PEG was the C18-U resin, which demonstrated a coating capacity of 97.6±2.8mg PEG per g of resin. The ability to adsorb pertechnetate was proportional to the amount of PEG coated on the hydrophobic resin. The [(99m)Tc]pertechnetate recovery during the separation of cyclotron produced (99m)Tc from (100)Mo was 91.8±0.3% (n=2). The resultant product met relevant USP monograph specifications.