Clinical Drug SupplyThe clean room 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. Both the facilities are holding a Swissmedic manufacturing license. The labs are regularly inspected for compliance with good practices as laid down in the Swiss Therapeutic Products Act and detailed in EudraLex, Volume 4, Good Manufacturing Practice (GMP) Guidelines.
Basic research at the CRS focuses on the improvement of diagnosis 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 the main responsibility 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, 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 intravenous. The products must therefore to be sterile which we usually achieve by aseptic production.
- Radioactive isotopes of medicinal use are rather short lived (minutes to a few days). Therefore the products 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 projects focus on peptides and peptide-like probes that are labeled with radio metals, such as lutetium-177, scandium-44 and gallium-68. These isotopes have half-lives of 68 minutes (Ga-68) to 6.7 days (Lu-177). Products labelled with these isotopes can be manufactured centrally at the Paul Scherrer Institute and distributed to Nuclear Medical Centers within Switzerland or even abroad, the range of distribution being limited by the half-life of the isotope. Scandium-44 is produced at the PSI itself using the injector 2 of the High Intensity Proton Accelerator (HIPA).
Selection of current projects:
68Ga-PSMA-11 PSI is a very sensitive PET tracer for diagnosing and staging of prostate carcinoma. This tracer is made available to regional hospitals, e.g. Kantonsspital Aarau and Kantonsspital Baden.
177Lu-PPF-11N, a gastrin derivative, is being manufactured for a clinical trial evaluating the benefit of the substance in the treatment of medullary thyroid carcinoma (MTC).
Aseptic preparation in a hot cell where the operator uses manipulators (left) and remote controlled syringe motors (right). The 10 cm thick lead shields and lead glass protect operator and environment from the radiation.