Clinical evaluation of novel PET tracers

The clean room facilities

at the CRS allow the manufacturing of safe radiopharmaceuticals for human application in compliance with Good manufacturing practice (GMP). CRS has two such facilities, one at the ETH Zürich Hönggerberg , AIC Animal Imaging Center and one at the Paul Scherrer Institute. Both the facilities are holding a Swissmedic manufacturing license.

Download swissmedic establishment licence (PDF, 995 KB)

Download gmp certificate (PDF, 711 KB)

Research at CRS focuses on the improvement of diagnosis and therapy of serious conditions (e.g. Alzheimer’s disease, malignant tumors). Drug candidates need to prove their safety and efficacy in clinical trials before they may be used in the clinical routine.
Translation of process methods from basic research to drug products suitable for human use and the supply of clinical trials with these products are the main responsibilities of the Clinical Drug Supply group.

Good and reproducible quality of the products is an absolute precondition both for the safety of the patients and the reliability of clinical data. Our quality assurance system is designed to control all relevant materials and operations beginning with the purchase of starting materials and equipment up to the delivery of the individual patient dose to the clinic. Means of guaranteeing the required quality are dedicated, trained personnel, qualified equipment and validated methods of production and control of the final product.

The integration of pharmacological, pre-clinical research and drug product manufacture in one academic institution facilitates fast transfer of scientific findings and inventions to clinical applications and processes.

Radiopharmaceuticals have some specific features:

• The standard route of administration is intravenous. The products must therefore be sterile which we usually achieve by aseptic production.
• Radioactive isotopes of medicinal use are rather short lived (minutes to a few days). Hence the products cannot be held on the shelf but must be manufactured just-in-time often for one patient individually.
• The production and quality control processes need to be very fast and robust at the same time.
Apart from bringing CRS own drug candidates to the clinic we also do joint projects with industry, e.g. develop, validate and manufacture radiotracers with clinical designation.

Activities at the ETH Zürich:

The projects focus on the clinical evaluation of novel PET tracers that are based on fluorine-18 compounds. Fluorine-18 has a physical half-life of 110 min. and is used in Positron Emission Tomography (PET), an evolving non-invasive diagnostic tool in the field of nuclear medicine.
The fluorine-18 is produced by an on-site cyclotron and directly delivered into the synthesis hot cells where it is reacted to form the drug substance. After purification and aseptic dispensing the sterile product is ready for shipment to the hospital. After successful quality control it is applied to the patient intravenously.