Clinical Drug Supply
The 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.
Research at CRS focuses on the improvement of diagnosis and therapy of serious conditions (e.g. 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 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, 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 analytics 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 Paul Scherrer Institute
The projects focus on peptides and peptide-like probes that are labeled with radio metals, such as lutetium-177 terbium-161 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.
Selection of current projects
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).
161Tb-DOTA-LM3, the combination of a novel radioisotope with a somatostatin receptor antagonist to be clinically evaluated for its use as a therapy of neuroendocrine neoplasia is currently in development.
New GMP production lab
In 2021 we finalized construction of a new GMP production lab in the same building, furnished with state of the art pharmaceutical grade shielded cells. After a transition period CRS will manufacture its drugs in the new lab exclusively. The capacity is 3 production units consisting of a shielded cell for synthesis with adjacent cell for aseptic filling each. These units are operated in an isotope dedicated mode, multiple different tracers per unit are possible as long as labeled with the same isotope.