Translational from-bench-to-bedside research activities

Biomedical services

The TUM Department of Nuclear Medicine is one of the largest Nuclear Medicine Departments in Europe. The Department has a long-standing experience in performing preclinical and clinical research in molecular imaging as well as therapeutic applications of new radiotheranostic tracers.

A specific strength of the department is the rapid translation of novel molecular imaging technologies to the clinic.

It operates radiochemistry facilities as well as preclinical and clinical imaging facilities for the testing and clinical translation of new radiopharmaceuticals. A description of these facilities and the services that the department offers to PRISMAP users can be found below.

Preclinical facilities

For housing animals treated with beta or alpha-emitting radionuclides. They are equipped with small animal imaging facilities (PET/MRI and SPECT/CT) for in vivo and in vitro characterisation of newly developed tracers.

Chemistry facilities

For radiolabelling with a variety of diagnostic and therapeutic radionuclides, including GMP facilities for clinical studies.

Clinical facilities

These are equipped with a dedicated treatment ward for radionuclide therapies for patients. Clinical trials are supported by a team of researchers within the department, that are highly experienced in the regulatory aspects of performing clinical trials with radionuclides.

Munich, Germany

Experiments available

Support for targeting agent and chelator development

In concert with the PRISMAP user the facility can help to characterise among different compounds a lead one suited for radiopharmaceutical development in terms of high affinity, selectivity and specificity for its target and rapid body clearance, and the most suited chelator for the desired action and radionuclide. Optimization of the targeting agent via chemical modification could be envisioned.

We do not offer production or synthesis of the lead compound nor the chelator.

Support for radiolabelling strategy and instrumentation for quality controls

Depending on the use (diagnostic vs therapeutic), the biomarker or interest (receptor or other target molecules overexpressed on tumour cells), the targeting agent (small molecule vs antibody/antibody derivatives) and the application (preclinical experiments vs clinical application), different labelling strategies might be proposed. These strategies may result in different final formulations of the radiotracers in terms of molar activity, pH, composition of the buffer and volume. Depending on the need, radiolabelling can be conducted in the GMP radiopharmacy (for clinical use) or at the research lab (preclinical use).

Preclinical studies
Chemical and radiochemical characterisation of the tracers selected
In vitro characterisation
  • Internalisation and intracellular/subcellular distribution studies
  • Dissociation studies
  • Blocking studies
  • Efficacy/functional assays
  • Cell proliferation assay
  • Metabolite analysis
  • Radiopharmaceutical stability during storage
  • Serum stability
  • Non radioactive supporting experiments
In vivo characterisation
  • In vivo stability studies
  • Metabolite analysis
  • Tracer biodistribution studies
  • microPET/SPECT imaging
  • Efficacy assay
  • Radioxicity and dosimetry study
Guidance to write regulatory documents to apply for clinical studies

PRISMAP biomedical facilities that offer this service can guide and help the applicant to gather, write and submit the different documents needed for a first in human clinical trial.

For an in depth review, please refer to the following publications:

Radiopharmaceutical GMP manufacturing and related documentation
Support to conduct clinical trial, general organisation and contact to authority