Radionuclides and GMP radiopharmaceuticals for clinical trials

Biomedical services

NCBJ-POLATOM (thereafter NCBJ) is the largest research institute in Poland and the operator of the nuclear research reactor MARIA. Radioisotope Centre POLATOM at the NCBJ is the department processing radionuclides for various applications. POLATOM is well prepared for producing radionuclides and synthesis of radiopharmaceuticals according to pharmaceutical standards (GMP) and for the preparation of radiopharmaceuticals for clinical trials. POLATOM has GMP certified laboratories for radiopharmaceutical manufacture including clean-rooms for aseptic manufacture of kits for 99mTc labelling, organic synthesis laboratory for active pharmaceutical ingredients and microbiology labs. For the investigation of radiolabelled compounds, the laboratories are equipped with advanced analytical instruments: HPLC systems with UV, MS, and radiometric detectors, ICP-Optical Emission Spectrometry, electronic autoradiography systems, optical microscopes, γ-spectrometry, and liquid scintillation counters.

POLATOM’s Preclinical Investigations Laboratory with animal facility is certified for safety evaluation (acute toxicity), imaging and organ distribution of locally manufactured radiopharmaceuticals and investigational drugs. Personnel of the laboratory is educated and trained to perform experiments respecting the rules of animal welfare. All experiments are conducted in accordance with Polish and EU law including the guiding principles of 3R’s (Replace, Reduce, Refine). The Laboratory of Radioactivity Standards is accredited (accreditation no. AP 120) for radioactivity measurements of ɑ, β and γ emitters by absolute methods.

Otwock-Świerk, Poland

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

We can offer support in:

  • determination of radioactivity and radionuclide purity by γ spectrometry
  • determination of radiochemical purity by TLC and HPLC methods
  • optimization of isotope labelling conditions (pH value, buffer composition, stabilizer concentration, metal-to-ligand ratio etc)
  • development of pharmaceutical formulations based on freeze-dried kits
Preclinical studies
Chemical and radiochemical characterisation of the tracers selected

Chemical characterization of the cold compounds before and after conjugation by HPLC and Mass Spectrometry:

  • Analytical HPLC
  • Mass Spectrometry (LC-MS)
  • Trace metal analysis (ICP-OES)
  • The facility is equipped to perform the radiochemical purity characterization of the radiotracer
  • Radio-HPLC
  • Radio-TLC
In vitro characterisation

The facility is able to provide a characterization with α-, β- and γ- radiotracers in relevant cellular models. The biosafety level for the laboratory is BSL-2.

To be noted that the NCBJ facility is not equipped to perform autoradiography.

  • Internalisation and intracellular/subcellular distribution studies
  • Saturation binding
  • Dissociation studies
  • Blocking studies
  • Cytotoxicity study
  • Annexin V assay
  • Viability and apoptosis study
  • Cell cycle analysis of fixed cells
  • Cell proliferation assay
  • Radiopharmaceutical stability during storage
  • Serum stability
  • Cryostat - frozen section histology
In vivo characterisation

The facility is accredited to host and conduct an animal study with conventional, immunodeficient and GMO rodent models (mice and rats).

  • In vivo stability studies
  • Metabolite analysis
  • Tracer biodistribution studies
  • microPET/SPECT imaging
  • Efficacy assay
  • Radiotoxicity and dosimetry study
Guidance to write regulatory documents to apply for clinical studies

Having experience in applying for approval of clinical trials for several new potential radiopharmaceuticals, we can provide assistance in preparation of the necessary documentation, including IMPD, IB and related SOPs.

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

Radiopharmaceutical GMP manufacturing and related documentation

We are GMP certified for radiopharmaceutical manufacture and for manufacture of Active Pharmaceutical Ingredients (API). Our GMP qualified personnel can support PRISMAP users in pharmaceutical development. In our R&D department there are GMP certified D and C grade clean-rooms for aseptic manufacture of investigational medicinal products (IMP) used in clinical trials. IMPs are produced in the form of ready to use solutions for injection labelled with locally produced radionuclides or in the form of freeze-dried kits for radiolabeling at the users site.

Support to conduct clinical trial, general organisation and contact to authority