Scientific Publications

May 19, 2017

Fully automated [18F]FAZA production on AllInOne at commercial scale.

M. Otabashi ; C. Vriamont ; T . Vergote ; C. Desfours ; J-L. Morelle and G. Philippart

Tumor hypoxia is a common feature of many solid malignant tumors. Hypoxic cells are known to be more than three times more resistant than those with normal oxygenation levels. It’s believed that hypoxia associated with malignant progression leads to an increase of the tumor invasive potential. The identification and quantification of such type of tumors will thus improve the monitoring and treatment of this kind of tumors. Many radio tracers have been used to diagnosis this type of tumors including [18F]FRP-170, [18F]FETNIM, [18F]FETA, [18F]FMISO and [18F]FAZA (1). The latter two are the most commonly used tracer for tumor hypoxia, although [18F]-FAZA gives much better images with very high contrast due to its quick clearance from blood and non-target tissue (3).
There is thus a strong need for an efficient fully automated method to match the needs of the market to this marker. We present hereby a fully automated method to produce  [18F]-FAZA with high reproducible yield.

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May 19, 2017

High reproducible yield [18F]-FCholine production on AllinOne at commercial scale

M. Otabashi ; C. Vriamont ; T. Vergote ; C. Desfours ; J-L. Morelle and G. Philippart

[18F]-Fluorocholine is used with Positron Emission Tomography to detect metastatic prostate cancer [1], recurrent brain tumors and hepatocellular carcinoma [2,3]. Automated methods to synthesize [18F]-Fluorocholine are available on several radiosynthesis platforms, but these approaches suffer from fluctuations of yield, emission of radioactive gas when using the older dibromomethane method and high quantity of 2-Dimethylethanolamine (DMEA) in the final product. Herein, we present an automated one-pot method with an improved purification for the efficient routine production of [18F]-Fluorocholine under cGMP conditions, avoiding the pitfalls of the gaseous method.

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May 19, 2017

High yield [18F]FET production on AllinOne (Trasis) at commercial scale

M. Otabashi, C. Vriamont, T. Vergote, C. Desfours, J-L. Morelle and G. Philippart

O-(2-[18F] fluoroethyl)-L-tyrosine ([18F]FET), a 18F-labeled amino acid for imaging amino acid metabolism in tumors, shows high uptake in the primary brain tumors (PBT). [18F]FET overcomes disadvantages of [18F]FDG and [11C] methionine tracers: [18F]FET is more specific than FDG and benefit from the longer half-life versus [11C] tracers. Accordingly, [18F]FET PET is a highly relevant tool for patient management [1-3]. Therefore, a robust synthesis combined with a high yield is requested and has been achieved by Trasis on the AllinOne synthesizer (Figure 1). This process requires no preparation prior to production, operates on ready-to-use consumables and facilitates implementation of GMP.

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May 19, 2017

Use of a Trasis AllinOne Synthesizer for routine clinical production of [68Ga]Ga-HBED-11-PSMA and [68Ga]Ga-DOTA-tate and [18F]fluorocholine

D. Stark and T. Vergote

[68Ga]Ga-HBED-11-PSMA (PSMA) and [68Ga]Ga-DOTA-tate (DOTAtate) are two well established PET tracers for diagnostic and staging of prostate cancer (PCa) and neuroendocrine tumours (NET) respectively. In our department we have used a Trasis AllinOne (AiO) synthesiser since late 2014 to routinely produce [68Ga]Ga-DOTA-tate, [18F]fluorocholine ([18F]FCH) and [68Ga]Ga-HBED-11-PSMA. [18F]FCH was initially produced for a comparative clinical trial to demonstrate the superiority of [68Ga]Ga-HBED-11-PSMA compared to [18F]FCH in diagnostic and staging of PCa[1]. In order to produce this range of radiolabelled compounds, a versatile, reliable, cassette based synthesizer was required.

May 5, 2017

Automation of the Radiosynthesis of Six Different 18F-labeled radiotracers on the AllinOne

Shihong Li, Alexander Schmitz, Hsiaoju Lee and Robert H. Mach

Fast implementation of positron emission tomography (PET) into clinical and preclinical studies highly demands automated synthesis for the preparation of PET radiopharmaceuticals in a safe and reproducible manner. The aim of this study was to develop automated synthesis methods for these six 18F-labeled radiopharmaceuticals produced on a routine basis at the University of Pennsylvania using the AllinOne synthesis module.


DOI: 10.1039/c6re00204h

February 8, 2017

A general [18F]AlF radiochemistry procedure on two automated synthesis platforms

L. Allott, C. Da Pieve, D. R. Turton and G. Smith

The aluminium fluoride-18 ([18F]AlF) radiolabelling procedure has generated great interest because it is a
simple, one-pot method that can be used to directly radiolabel small molecules, peptides and proteins
without the requirement for a [18F]fluoride drying step. Reported here is the development of an automated
[18F]AlF radiolabelling procedure of three different precursors (one small molecule and two peptides) on
two automated synthesis platforms: GE TRACERlab FXFN and Trasis AllInOne (AIO). Aiming at the clinical
translatability of a [18F]AlF radiosynthetic methodology, the use of both platforms yielded radioconjugates
with >98% radiochemical purity (RCP) within 26–35 min and required a single rapid purification step. The
Trasis AIO platform gave improved [18F]fluoride incorporation, and generally produced radioconjugates with a higher radiochemical yield (RCY) and effective specific activities (SA) when compared to the GE TRACERlab FXFN system.

DOI: 10.1039/c6re00204h


November 9, 2016

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients

Frederik L. Giesel & B. Hadaschik & J. Cardinale & J. Radtke & M. Vinsensia1 & W. Lehnert & C. Kesch & Y. Tolstov & S. Singer & N. Grabe & S. Duensing & M. Schäfer & O. C. Neels & W. Mier1 & U. Haberkorn1 & K. Kopka & C. Kratochwil

18F-PSMA-1007 produced on Trasis AllInOne automated synthesis module was proven to perform at least comparably to 68Ga-PSMA-11 and overcomes some practical limitations of 68Ga-labelled PSMA-targeted tracers.

DOI 10.1007/s00259-016-3573-4

October 10, 2016

Automation of the Radiosynthesis of Six Different 18F-labeled radiotracers on the AllinOne

Shihong Li, Alexander Schmitz, Hsiaoju Lee and Robert H. Mach*

The six radiopharmaceuticals were obtained in high yield and high specific activity with full automation on the AllinOne synthesis module under current good manufacturing practice (cGMP) guidelines. The study demonstrates the versatility of this synthesis module for the preparation of a wide variety of 18F-labeled radiopharmaceuticals for PET imaging studies.

DOI 10.1186/s41181-016-0018-0

August 30, 2016

Enabling Efficient PET Imaging of Synaptic Vesicle Glycoprotein 2A (SV2A) with a Robust and One-Step Radiosynthesis of a Highly Potent 18F‑Labeled Ligand ([18F]UCB-H)

Corentin Warnier,Christian Lemaire, Guillaume Becker, Guillermo Zaragoza, Fabrice Giacomelli, Joël Aerts, Muhammad Otabashi, Mohamed Ali Bahri, Joël Mercier, Alain Plenevaux, and André Luxen

The study describes the straightforward synthesis of a stable pyridyl(4-methoxyphenyl)iodonium salt and its [18F] radiolabeling on the Trasis AllinOne synthesizer within a one-step, fully automated and cGMP compliant radiosynthesis of [18F]UCB-H ([18F]7), a PET tracer for the imaging of synaptic vesicle glycoprotein 2A (SV2A).

DOI: 10.1021/acs.jmedchem.6b00905

August 16, 2016

[18F]MEL050 as a melanin-targeted PET tracer: Fully automated radiosynthesis and comparison to 18F-FDG for the detection of pigmented melanoma in mice primary subcutaneous tumors and pulmonary metastases

Nathalie Rizzo-Padoin, Michael Chaussard, Nicolas Vignal, Ewa Kotula, Vadim Tsoupko-Sitnikov, Sofia Vaz, Fortune Hontonnou, Wang-Qing Liu, Jean-Luc Poyet, Michel Vidal, Pascal Merlet, Benoit Hosten, Laure Sarda-Mantel

Successful implementation of the the radiosynthesis of [18F]MEL050 using the AllInOne module, including HPLC purification and formulation.

July 20, 2016

Fully automated, robust and reproducible synthesis of 16α-18Ffluoroestradiol (18F-FES)

Guillaume BLUET, Cathy AUBERT, Florence GRUSS-LELEU, Laurent BESRET, Sébastien D’HEILLY, Sébastien ROY, Muhammad OTABASHI and Laurent BRICHARD

The study describes an in-house automated, reliable and reproducible radiosynthesis using the AllInOne synthesizer for the routine production of [18F]-FES for preclinical studies. The easy to use module allowed to develop efficient automated synthetic and purification procedures to obtain [18F]-FES in good radiochemical yields (up to 25% ndc) within just 45 min.

July 17, 2016

High-yield fully automated production of [18F]Fluoro-Choline at High Activity on the AllinOne Synthesizer

M, Otabashi; C, Desfours; T, Vergote; L, Brichard; JL, Morelle and G, Philippart - Trasis

A fully automated method was developed on the AllinOne synthesizer , with high and reproducible yields at all activity levels using ready-to-use kits. The results show no radioactive gases, extremely low levels of DMAE and compliance with any QC testing required.