Clinical Drug SupplyThe GMP facilities at the CRS allow the manufacture of safe radiopharmaceuticals for human application. The CRS has two such facilities, one at the Paul Scherrer Institute and one at the ETH Zürich Hönggerberg, AIC Animal Imaging Center.
Basic research at the CRS focuses on the improvement of diagnostics and therapy of various serious conditions (e.g. malignant tumors). Drug candidates need to be evaluated in clinical trials and prove their safety and efficacy before they may be routinely used. The translation of process methods from basic research to drug products suitable for human use is done by 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, educated personnel, qualified equipment and validated methods of production and control of the final product.
The integration of drug product manufacture and basic research 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 intravenously. The product needs therefore to be sterile which is usually achieved by an aseptic production process.
- Radioactive isotopes of medicinal use are rather short lived (minutes to a few days). The consequence is that the product cannot be held on the shelf but must be produced just-in-time for each patient individually.
- The production and analytics need to be very fast and robust at the same time.
Activities at the Paul Scherrer Institute:
The site is licensed by Swissmedic, the Swiss Agency for Therapeutic Products for the production of radiopharmaceuticals for clinical trials.
The projects focus on peptides and monoclonal antibodies that are labeled with radiometals, such as lutetium-177, scandium-44 and yttrium-90. These isotopes have a half-life of 4 hours (Sc-44) to 6.7 days (Lu-177). Products labelled with these isotopes can be manufactured centrally at the Paul Scherrer Institute and distributed to practically every Nuclear Medical Center of Switzerland or even abroad. Scandium-44 is produced at the PSI itself using the injector 2 of the High Intensity Proton Accelerator (HIPA).
Products labeled with shorter lived radiometals are also developed, such as peptides labelled with gallium-68 (half-life of 68 min.). For the realization of clinical trials these processes are transferred to the clinic where the patients are treated.