Radionuclides and GMP radiopharmaceuticals for clinical trials
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 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, gamma-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 alpha, beta and gamma emitters by absolute methods.