Pharm'image

Radiochemistry

Overview

Pharm’image EIG coordinates a research and development platform in radiochemistry and radiopharmaceutical, located in dedicated buildings equipped with a GE cyclotron for Fluor-18 targets which is operated by Cyclopharma. It also has the appropriate infrastructure to conduct Fluor-18 radiolabeling for experimental medicine production. The establishment is accredited by the Nuclear Safety Authority (ASN), and the radiopharmaceutical unit is integrated to the Hospital Pharmacy of the Georges-François Leclerc Center (CGFL).
To complete this platform, the radiolabeling laboratory of the preclinical imaging department is capable of performing radiolabeling with other isotopes that are complementary with Fluor-18.
Both of the nuclear medicine departments at the CGFL (Dijon) and CH Pierre Beregovoy (Nevers) possess radiolabeling and quality control equipments that enable their clinical activities.

Equipment

Applications

Development / validation of radiolabeling methodologies, including analytical characterization (e.g. radiochemical purity) and biological characterization (e.g. affinity studies, apyrogenicity-sterility)
The design of radiolabeled molecules in order to realize in vitro and in vivo pharmacology studies
Process development and validation for preparations under aseptic conditions to produce clinical batches.
Quality documentation writing for the preparation of experimental radiopharmaceuticals.
Production of clinical doses of radiopharmaceuticals (radiopharmacy hospital uses).
Scale-up for commercialization

Preclinical imaging

Overview

To complete Oncodesign preclinical MRI capabilities, the Pharm’image preclinical imaging platform was created in 2011 in the nuclear medicine department of the CGFL (the region’s comprehensive anti-cancer center).
This infrastructure which is dedicated to preclinical imaging, is accredited by the French authorities for both the handling of radioactivity (ASN) and animal housing (DDPP).
Preclinical and clinical imaging share the same imaging modalities and biomarkers. Preclinical imaging is therefore a translational tool that can reduce the costs and timelines of the drug development process, by narrowing the gap between basic science and clinical proof of concept.

Equipment

Applications

Numerous imaging endpoints (morphological, functional and molecular) were developed in different areas: Pharmacology, Oncology, Cardiology, and Nuclear Medicine.

Clinical imaging

Overview

Three clinical imaging departments highly involved in research activities are part of the Pharm’image consortium:

The nuclear medicine department of the Georges-François Leclerc cancer center (CGFL): equipped with 3 gamma-cameras, one of which is associated with a scanner (SPECT/CT), and one positron emitted tomography (PET) coupled to a scanner (PET/CT). A second PET/CT, shared with the Dijon university hospital, will be installed in July 2017. A Gallium68 generator will also be available for clinical use over the course of 2017. The CGFL nuclear medicine team has considerable experience in vectorized radiotherapy. Two hospital rooms are dedicated to brachytherapy. Finally, this department hosts the preclinical imaging platform.
Three MRI, three CT scanners and one interventional radiology platform are available in the imaging center of Dijon-Burgundy university hospital. This department is composed of 3 units: neuroradiology and emergency imaging, therapeutic and diagnostic medical imaging, cardiac MRI and NMR spectroscopy. The imaging center covers all the therapeutic and diagnostic radiology application domains.
The nuclear medicine department of the Pierre Beregovoy hospital in Nevers (CHAN) has two SPECT/CTs and one PET/CT. This department has close links to the CGFL nuclear medicine department in research and clinical activities.