Scientific and research activity
Scientific and research works carried out at OR POLATOM are of a cognitive and application character. Research topics include, among others:
- tests for the production of radiopharmaceuticals and active substances for medicinal products, which, in combination with a radioactive isotope, will allow to obtain the effect of imaging changes in the patient’s body and/or for their treatment;
- synthesis and modification of biologically active molecules as well as nano- and micro-particles as carriers for radioisotopes and other probes increasing diagnostic and therapeutic effectiveness;
- innovative medicinal products (multimodality probes);
- conducting pre-clinical evaluation studies, drug safety studies and developing documentation necessary for the admission of potential new drugs to clinical trials.
Research Department
The Research Department (DB) conducts research and development work in the field of the use of nuclear techniques in various fields of science. In particular, these are studies on:
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- obtaining radionuclides in the Maria reactor,
- development of technologies for obtaining radionuclides in cyclotrons,
- developing methods of obtaining new markers for diagnostics and isotope therapy based on biologically active carriers such as peptides and monoclonal antibodies,
- development of methods for the synthesis of tags for PET diagnostics,
- designing multifunctional tags with the use of nanoparticles,
- development of analytical and biological methods enabling the assessment of the quality and potential therapeutic efficacy of new isotope drugs under development.
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The Research Department participates in the development of registration documentation for radiopharmaceuticals and prepares documentation for investigational medicinal products (IMP) for the needs of clinical trials developed in the department of innovative radiopharmaceuticals. The research unit (DB) consists of 4 laboratories:
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- Radiopharmaceuticals Laboratory (BR)
- Laboratory of Radionuclides (BZ)
- Laboratory of Active Substances (BS)
- Laboratory of Preclinical Research (BP)
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Quality Control Laboratory
The basic tasks of the Quality Control Laboratory include:
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- quality control of starting materials, printed materials, packaging, intermediate products and finished products as per specification requirements,
- control of radiopharmaceutical production conditions in accordance with GMP requirements,
- validation of the analytical methods used, supervision of reference and archival samples, conducting development works in the field of chemical, microbiological and radiochemical analysis of radioactive materials,
- development of OR POLATOM quality system documentation in accordance with the applicable procedures.
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These tasks are carried out in three laboratories:
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- Laboratory of Chromatographic Analyzes (DA-1)
- Laboratory of Physicochemical Analyzes (DA-2)
- Laboratory of Microbiological Research and Control of Scintigraphic Sets (DA-3)
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The work of the Quality Control Laboratory is organized in accordance with the requirements of GMP and the ISO 9001 standard. The competences of the Laboratory are confirmed by PCBC quality system audits in accordance with the requirements of the PN-EN ISO9001 standard, GIF inspections, audits of foreign recipients, participation in interlaboratory tests, among others in the field of determination of radiochemical purity and determination of the content of bacterial endotoxins.
Radioactivity Standards Laboratory
The Radioactivity Standards Laboratory at the National Center for Nuclear Research, POLATOM Radioisotope Center in Świerk is the only laboratory in the country that measures the activity of α-, β- and γ-radioactive radionuclides with absolute methods and produces standard radioactive solutions and sources.
Since 1999, RSL has been the depositary of the National Standard of the Unit of Measurement of Radioactive Activity of Radionuclides established by the President of the Central Office of Measures on the basis of absolute measurement systems developed and used in the laboratory.
The laboratory has implemented a management system compliant with the PN-EN ISO / IEC 17025: 2018-02 standard. The confirmation of the laboratory’s competence is the accreditation granted by the Polish Center for Accreditation in 2008 and extended in subsequent years to all used measurement methods.
