On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard.

Menon, Sreeja Raj; Mitra, Arpit; Sahu, Sudeep; Lad, Sangita; Chakraborty, Avik; Ray, Mukti Kanta; Banerjee, Sharmila

doi:10.22038/aojnmb.2024.77059.1545

On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard.

Document Type : Original Article

Authors

¹ 1) Health Physics Division, Bhabha Atomic Research Centre, 2) Homi Bhabha National Institute, Mumbai

² Radiopharmaceutical Laboratory, Board of Radiation and Isotope Technology

³ Radiation Medicine Centre Bhabha Atomic Research Centre

⁴ 1) Radiation Medicine Centre, Bhabha Atomic Research Centre, Mumbai, 2) Homi Bhabha National Institute, Mumbai

⁵ 1) Radiation Medicine Centre, Bhabha Atomic Research Centre, Mumbai 2) Homi Bhabha National Institute, Mumbai

⁶ Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

10.22038/aojnmb.2024.77059.1545

Abstract

Objective: The present work describes the automated radiochemical syntheses of different PET tracers like [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE using optimized single protocol in the non-cassette based Eckert & Ziegler (EZ) Modular Lab (fixed tubing system) without any modification in the inbuilt human machine interface (HMI) software. Recently, PET agents viz. [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 are gaining prominence for the diagnosis of overexpressed Chemokine Receptor-4 (CXCR4) and Fibroblast Activation Protein (FAP) receptor, respectively, in the microenvironment of numerous cancer types. The promising results observed with the clinical usage of [68Ga]Ga-DOTATATE produced using the automated protocol, provided impetus for the clinical translation of [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 using the in-house developed automated radiolabeling protocol.
Methods: Herein we report a single radiolabeling protocol for the automated preparation of [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 in the non-cassette based EZ Modular-Lab Standard radiochemistry module, without any changes in schematic, graphical user interface (GUI) software and time list, from that used for routine production of [68Ga]Ga-DOTATATE in our centre, since 2015. Physico-chemical quality control and in-vitro stability analyses were carried out using radio-TLC and radio-HPLC.
Results: The automated protocol yielded reliable and consistent non-decay corrected (ndc) radiochemical yield (RCY) of (84.4±0.9)% and (85.5±1.4)% respectively, for [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4, with RCP> 98%, which are comparable to the RCY of (84.4±1.2)% and RCP (99.1±0.3)% for [68Ga]Ga-DOTATATE. The biological quality control studies confirmed the formulations to be of ready-to-use pharmaceutical grade.
Conclusion: The consistent and reliable RCY and RCP of multiple 68Ga-labeled PET tracers by single optimized automated radiochemistry protocol exhibits the versatility of the EZ Modular Lab.

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