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Automation of a Positron-emission Tomography PET Radiotracer Synthesis Protocol for Clinical Production
Published on: October 26, 2018
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Development and application of a fully automatic multi-function cassette module Mortenon M1 for radiopharmaceutical
Fang-Bo Cui1, Xuan Lv2, Cheng-Long Yan2
1Department of Oncology, The People's Hospital of Ma Anshan, Ma Anshan, 243000, Anhui, People's Republic of China.
Annals of Nuclear Medicine
|December 25, 2023
Summary
The Mortenon M1 is a new automatic module system for radiopharmaceutical synthesis. It efficiently produces radiolabeled small molecules and antibody drugs, improving safety and diagnostic imaging.
Area of Science:
- Radiochemistry
- Nuclear Medicine
- Biotechnology
Background:
- Existing automatic radiopharmaceutical synthesis modules primarily focus on small molecules.
- Limited systems offer full automation for both metallic and non-metallic radiolabeling of diverse compounds like peptides and antibody drugs.
Purpose of the Study:
- To develop and evaluate Mortenon M1, a fully automatic, multifunctional module for safe, stable, and efficient radiopharmaceutical production.
- To assess its capability for synthesizing various radiolabeled molecules using different radionuclides.
Main Methods:
- Designed a cassette-based, fully automatic synthesis module (Mortenon M1) using UG and Solidworks.
- Mortenon M1 features disposable cassettes, flexible programming, and suitability for small and large molecules with radionuclides like 18F, 64Cu, 68Ga, 89Zr, and 177Lu.
- Radiolabeling of [68Ga]-FAPI-46 (small molecule) and [89Zr]-TROP2 antibody (macromolecule) was performed and validated using radio-iTLC, radio-HPLC, and microPET imaging.
Main Results:
- Mortenon M1 successfully synthesized [68Ga]-FAPI-46 and [89Zr]-TROP2 antibody with high yields (70.63% ± 2.85% and 82.31% ± 3.92%, respectively).
- Radiochemical purity exceeded 99% for both products after purification.
- MicroPET imaging in xenograft tumor models demonstrated satisfactory tumor uptake and biodistribution of the radiolabeled tracers.
Conclusions:
- The Mortenon M1 system is highly efficient for automated radiolabeling of both small and large molecules.
- This technology enhances radiopharmaceutical production safety, product quality, and diagnostic imaging reliability.
- It offers potential for stable supply of radiopharmaceuticals and reduced radiation exposure for operators.

