A fully automated synthesis for the preparation of <sup>64,67</sup>Cu-SARTATE using the iPHASE MultiSyn Radiosynthesiser — ASN Events
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  3. A fully automated synthesis for the preparation of 64,67Cu-SARTATE using the iPHASE MultiSyn Radiosynthesiser

A fully automated synthesis for the preparation of 64,67Cu-SARTATE using the iPHASE MultiSyn Radiosynthesiser (#69)

Charmaine Jeffery 1 2 , Stan Poniger 3 4 , Henri Tochon-Danguy 3 4 , Peter Roselt 5 , Matt Harris 1
  1. Clarity Pharmaceuticals, Eveleigh, NEW SOUTH WALES, Australia
  2. Centre for Advanced Imaging, The University of Queensland, St Lucia, QUEENSLAND, Australia
  3. iPHASE technologies Pty Ltd, Melbourne, VICTORIA, Australia
  4. Molecular Imaging and Therapy, Austin Health, Heidelberg, VICTORIA, Australia
  5. Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, VICTORIA, Australia

The MultiSyn (iPHASE technologies, Melbourne1) is a compact and GMP-compliant radiosynthesis module; which utilises cassette-based technology and has been designed to radiolabel with a variety of isotopes (68Ga, 64,67Cu, 177Lu, 18F, 124I, 89Zr, 90Y) for PET imaging and radiotherapy.

In this study, we implement and evaluate the automated manufacture of 64Cu-SARTATE and 67Cu-SARTATE on the MultiSyn, for paired PET/CT imaging and radiotherapy of somatostatin subtype 2-expressing cancers.

Previously, 64Cu-SARTATE had been prepared for use in humans by utilising a manual synthesis method. Experiments were undertaken to adapt this manual synthesis method to the MultiSyn, looking at optimising radiolabelling conditions over a range of temperatures (room temperature to 90°C) and reaction times.

The prepared peptide in buffer is loaded directly into the reactor manually, whereas all other reagents are pre-loaded into vials and installed onto the cassette during initial set up of the module. The buffered 64Cu or 67Cu solution is pre-loaded into a syringe and automatically dispensed into the reactor containing the peptide.  The reaction mixture was left to react at different times and temperatures.

The reaction mixture was then passed through a Phenomenex Strata-X SPE tube, the tube washed with saline and the radiolabeled peptide eluted with 0.5-1mL ethanol and reformulated in saline (10% ethanol) before passing through a sterilizing filter. The determination of the radiochemical purity was performed using HPLC.

The radiolabelling process, including SPE purification, takes 23min and preliminary experiments show a non-decay corrected radiolabelling yield of 76%.

Results show that the automated method reliably and efficiently produces 64,67Cu-SARTATE that meets QC specifications for use in humans.

In conclusion, a consistent and reliable automated method for the manufacture of both radiopharmaceuticals 64Cu-SARTATE and 67Cu-SARTATE has been developed, which is suitable for use in clinical trials and can be GMP compliant.  

  1. 1. iPHASE technologies Pty Ltd; Website: www.iphase.com.au