POLATOM

Radioisotope Centre POLATOM is a department of the National Centre for Nuclear Research (NCBJ) located in Otwock, Poland, about 30 km south of Warsaw. POLATOM’s Preclinical Investigations Laboratory is part of the Research Department. The facility supports the development of novel radionuclides and radiopharmaceuticals, their pre-clinical validation and subsequent translation to clinical use, including pharmaceutical formulation, GMP manufacturing of Investigational Medicinal Products (IMP’s) and preparation of relevant dossiers (IMPD and IB). It combines radiochemical expertise, GMP-certified radiopharmaceutical manufacturing infrastructure and dedicated preclinical research capabilities based on the broad portfolio of radionuclides irradiated in the NCBJ’s MARIA research reactor and the newly launched facility with multi-particle Cyclone 30 XP, a 30 MeV cyclotron that accelerates protons, deuterons and alpha particles.

POLATOM’s facility is well-prepared to conduct studies on the radiolabelling of radiopharmaceutical candidates and their assessment, from early in vitro characterisation to in vivo validation in small-animal models. Available infrastructure includes laboratories for cell-based assays, a small-animal facility for studies in mice and rats, gamma-counting equipment for organ and tissue radioactivity measurements, and dedicated small-animal imaging systems, including SPECT/CT and PET/CT. The laboratory supports studies of biodistribution, pharmacokinetics and pharmacodynamics, receptor specificity, cellular uptake, cytotoxicity, safety evaluation and organ-level accumulation of radiolabelled compounds.

All animal studies are performed by trained personnel in accordance with applicable Polish and European Union regulations, with respect for animal welfare and the 3R principles: Replace, Reduce and Refine. The laboratory is registered as an experimental unit authorised to perform animal experiments and supports preclinical studies required for the development of locally manufactured radiopharmaceuticals and investigational drugs.