Better understanding, prediction and treatment of cancers and neurodegenerative diseases: the example of the Frédéric Joliot Hospital in Orsay

THE PROBLEM: "DESIGN AN INNOVATIVE PLATFORM FOR THE RADIOLABELLED DRUGS MANUFACTURE"

Better understanding, prediction and treatment of cancers and neurodegenerative diseases. This is the main mission of the CEA, Frédéric Joliot Hospital Department (SHFJ), through its pioneering nuclear medicine department and its BioMaps (Multimodal Biomedical Imaging Paris-Saclay), located within the Orsay hospital.

The SHFJ is a recognised centre for medical imaging research, equipped to manufacture radiopharmaceuticals on site for positron emission tomography (PET) imaging. It has placed its trust in Lemer Pax since 1975, when the first Lemer Pax cyclotron and shielded enclosures were delivered. Every day, the technical platform for manufacturing radiotracers and radiopharmaceutical preparations for biomedical research produces compounds labelled for use in clinical or preclinical PET scans.

The shielded production equipment is placed in a class C environment to meet the required health and safety conditions.It must comply with the standards in force for the manufacture and syringing of PET radiopharmaceutical preparations intended for injection into humans during clinical trials using positron-emitting radioisotopes such as fluorine-18, carbon-11, gallium-68, copper-64 or zirconium-89, etc.

When it comes to long-term labelling for oncology protocols for the preparation of antibody or protein radiopharmaceuticals, zirconium-89 is used with a pharmaceutical class A back-up to carry out sterilising filtrations of the labelled radiopharmaceutical preparations, then doses are prepared for clinical trials. Zirconium-89 is a PET emitter with a long half-life, unlike carbon-11 and fluorine-18, which can be used to visualise the processes of enzyme synthesis and antibody incorporation.

RS-75 Hot cell

Radiosynthesis shielded hot cell for research

The solution: "install shielded hot cells for ultra-controlled production in complete safety".

This shielded class A hot cell, with glove ports and with laminar flow is equipped with a class B access hood for the entry and exit of small sterile dispensing and packaging materials, and a class B exit airlock with interlocked doors for sampling PET radiopharmaceutical preparations in syringe form in their shielded protection. Under the shielded enclosure is a class C shielded hot cell, compatible with the Gas Compression System (GCS), which can contain an automatic radiosynthesis machine for gallium-68, copper-64 or zirconium-89, for example, and a Posisafe® shielded pot. The radiosynthesis product flows into the class A shielded hot cell with laminar flow through a partition passage for sterile pyrogen-free tubing.

This equipment has a major advantage. I have a synthesis chamber underneath which sends the product directly to me at the end of the synthesis in the class A chamber above to carry out the sterilising filtration and therefore prepare the patient syringe. It is then administered in complete safety, thanks to the connection of a shielded airlock. The other strong point of this class A hot cell is that at the cold material inlet there is a small class B laminar flow, which disinfects all the material you bring into class A.

Philippe Gervais

Doctor in radiopharmacy, international expert for the CEA

Installation: "customized support covering all needs"

Lemer Pax and the SHFJ know each other well, having worked together since 1975, when the first Lemer Pax hot cells were ordered. Lemer Pax recently produced a high-tech, custom-built shielded hot cell system that meets the specifications and strict criteria of safety, ergonomics and functionality, and which has been giving full satisfaction to the scientists for over 6 months. The installation, which was perfectly tailored to the requirements, also involved opening a removable bay and reassembling a partition in the production class C laboratory, before going into production.

Vincent Le bon, Chef de Service CEA-SHFJ

Thanks to this unique Lemer Pax equipment, the SHFJ is able to produce radiopharmaceuticals for medical research with a high degree of reliability. These radiopharmaceuticals are used to carry out molecular imaging clinical trials at the SHFJ, as well as in around eight French university hospitals, to which we deliver the radiolabelled molecules using the Lemer Pax equipment. These clinical trials provide invaluable insights into the mechanisms of neurological and cancer diseases and into patient response to innovative therapies.

Pr Vincent Lebon

Director of UMR BioMaps and Head of CEA-SHFJ, Paris-Saclay University

Lemer Pax has provided the service, and more, since the radiosynthesis chamber can already be connected to a cyclotron, thanks to a mechanical and automatic predisposition. This will happen in 2027, when the SHFJ moves to the Saclay plateau, next to the new GHNE hospital, as part of the PASREL project.

Results and benefits

Human-machine interface via screen
Remote screen for viewing inside the synthesis hot cell
Complies with GMP regulations, can be installed in any C class
Completely safe system thanks to a gas compression system

Better understanding, prediction and treatment of cancers and neurodegenerative diseases: the example of the Frédéric Joliot Hospital in Orsay

THE PROBLEM: "DESIGN AN INNOVATIVE PLATFORM FOR THE RADIOLABELLED DRUGS MANUFACTURE"

The solution: "install shielded hot cells for ultra-controlled production in complete safety".

Installation: "customized support covering all needs"

Results and benefits

CONTÁCTENOS PARA UN ESTUDIO DE SU PROYECTO

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