DEPARTMENT OF RADIOPHARMACEUTICALS

Department of Radiopharmaceuticals was established in 1968 in order to evaluate quality of the radiopharmaceuticals manufactured in Poland as well as of the new radiopharmaceuticals in the process of their application for marketing authorization in Poland. The Department is located on the premises of the Radioisotope Centre POLATOM in Otwock-¦wierk. The localisation of the Department in the controlled nuclear zone resulted from the safety precautions demanded for the laboratory working with highly radioactive radiopharmaceutical preparations.

Staff and Structure:

Head of the Department: Piotr Garnuszek, Ph.D.
phone: 22 718-07-41
fax.: 22 718-07-40
e-mail: 

Radiochemistry Laboratory
Michał Maurin, M.Sc., Eng.
phone: 22 718-09-26
e-mail: 

Radiobiological Laboratory (work-stand for biodistribution, work-stand for in vitro tests, the small animal facility)
Head: Urszula Karczmarczyk, Ph.D., Eng.
phone: 22 718-09-26
fax.: 22 718-07-40
e-mail: 

Ewa Laszuk, M.Sc.; phone: 22 718-07-40
Anna Jęderka, technician; phone: 22 718-07-40
Barbara Majewska, technician; phone: 22 718-07-40
Robert Łepkowski, technician; phone: 22 718-07-40

Major Activities:

Quality control of radiopharmaceuticals

The process of quality control of radiopharmaceuticals performed by Department of Radiopharmaceuticals is comprehensive and involves e.g. radiochemical purity testing, qualitative and quantitative evaluation of chemical composition, as well as the suitable biological tests. Various analytical techniques such as TLC, radioelectrophoresis, HPLC and UV spectrophotometry are applied to assess chemical and radiochemical parameters. Biological evaluations of the radiopharmaceuticals include biodistribution studies in small normal rodents (mice, rats), determination of pharmacokinetics, as well as safety tests, such as abnormal toxicity, sterility and bacterial endotoxins (LAL) determinations. The Department of Radiopharmaceuticals applies the analytical procedures under the terms of PN EN ISO/IEC 17025: 2005 for testing and calibration laboratories. A very important task of The Department of Radiopharmaceuticals is to support The Office for Registration of Medicinal Products, Medical Devices and Biocides in the evaluation processes of the chemical-biological-pharmaceutical documentations for radiopharmaceuticals applied for marketing authorisation in Poland.

Scientific research

Scientific activity of the Department is strictly connected with development and investigations of novel radiopharmaceuticals for diagnostic and radiotherapeutical purposes. Both radiochemical and biological methods are applied for the comprehensive preclinical evaluation of the new potential drugs. Biological studies include in vitro evaluation of the radioactive preparations on various tumour cell lines (i.e. cytotoxicity, binding, internalization), as well as in vivo biodistribution and pharmacokinetics determinations in normal and tumour-bearing mice or rats.
On April 24th 2003 The Department of Radiopharmaceuticals co-initiated foundation of the Research Centre of Nuclear Medicine. The intention of The Centre is close scientific cooperation between laboratories and institutions dealing with radiopharmacy and nuclear medicine, which means: collective application for grants, exchange of experience and apparatus, etc.

Participation in the research grants:

  • No. N405 020 31/0911  Development and Evaluation of New Radioactive Platinum Complexes of Modified Pharmacokinetics. (IX.2006-I.2009).
  • No. 2 P05A 024 28         Development of Methods for Preparation and Investigation of Receptor Specific Ligands Labelled with Radioactive Isotopes for Oncological Diagnostics, Molecular Imaging and Targeted Receptor Therapy. (IV.2005 - IV.2008).
  • No. 3 T11E 038 28         New Radiotracers in Diagnosis of Tumour Angiogenesis. (III.2005 - III.2007).
  • No. 2 P05B 003 28         The Development of Technetium 99m Labelled Interleukin-2: A New Radiopharmaceutical for In Vivo Detection Of Chronic Inflammatory Process in Vascular Wall in Patients Treated with Peritoneal Dialysis Because of End-Stage Renal Disease Complicated by Dynamic Atherosclerosis Progression. (III.2005 - III.2007).
  • No. 3 P05F 004 23         In Vivo Investigation of Anticancer Synergy of Platinum(II) Complexes with Radioactive [131I/125I]Iodohistamine. (X.2002 - IX.2004).
  • No. 4 P05F 014 19         Strategy Development of the Designing Drugs Active Against Multidrugresistant Cancers. (VII.2000 - VI.2003).
  • No. 4 P05F 014 16         Synthesis, Physicochemical Characteristic, and Evaluation of Usefulness in the Clinical Diagnostic Methods of the New Carboxylic Derivative of Dithizone. (I.1999 -I.2000).

Realization of the NIPH Research Program for year 2007:

2.13: Structure modifications of radioactive platinum(IV) complex with [*I]histamine.
3.15: Development of methods for preparation and investigation of receptor specific ligands labelled with radioactive isotopes for oncological diagnostics, molecular imaging and targeted receptor therapy.
3.16: New Radiotracers in Diagnosis of Tumour Angiogenesis.

Official Cooperation:

  • Office for Registration of Medicinal Products, Medical Devices and Biocides.
  • Polish Pharmacopoeia - Subcommittee of the Radiopharmaceutical Preparations.

Scientific Cooperation:

  • Research Centre of Nuclear Medicine (co-initiator).
  • Radioisotopic Centre POLATOM in ¦wierk.
  • Department of Radiological Protection and Radiobiology at Military Institute of Higiene and Epidemiology in Warsaw.
  • Laboratory of Nuclear Medicine, Department and Clinic of Endocrinology at Faculty of Medicine Collegium Medicum, Jagielonian University in Cracow.
  • Dipartimento Scienze Cliniche Policlinico Unberto I, Rome.

Service offered by The Department of Radiopharmaceuticals:

  • radiolabelling of chemical substances and biological active ligands (e.g. peptides, antibodies, cytokines, etc) with radionuclides: I-125, I-131, Tc-99m, Lu-177, etc;
  • chromatographic analysis of radiolabelled compounds by HPLC, TLC and radioelectrophoresis techniques;
  • in vitro testing of radioactive compounds on tumour cells;
  • sterility testing and bacterial endotoxin determination in radiopharmaceutical preparations;
  • biodistribution and pharmacokinetics determination of radioactive compounds on normal and tumour-bearing rodents (mice and rats);
  • abnormal toxicity testing of the radiopharmaceuticals.

Essential Equipment:

Radiochemistry Laboratory
  • WIZARD 1470 Gamma Counter (Wallac LKB);
  • HPLC System (Class VP series, Shimadzu) supplied with on-line gamma radio-detector (BioScan);
  • Radioscanner for authoradiography Mini-Scan TLC (Bio-Scan);
  • Ionization chamber ROBOTRON;
  • UV-Vis Spectrophotometer (Shimadzu);
Radiobiological Laboratory
  • Metabolic cages;
  • Gamma counters adapted for measurement of biological samples, isolated organs and the whole-bodies;
  • Radio-scanner for planar scintigraphy of mice and rats (Berthold);
  • LF hood adapted for working with radioactive preparations HB 2448 (Heto-Holten);
  • CO2 incubator IGO cell life (Jouan);
  • Fluorescent Microscope (Olympus).

Most Representative Scientific Publications (since 2002)

  1. P. Garnuszek, I. Licińska, J. S. Skierski, M. Koronkiewicz, M. Mirowski, R. Wiercioch, and A. P. Mazurek
    Biological investigation of the platinum(II)-[*I]iodohistamine complexes of potential synergistic anti-cancer activity.
    Nucl. Med. Biol. 29(2), 169-175 (2002).
  2. Michalska W, Garnuszek P, Licińska I, Wilgus J, Szymańska K, Rowiński W, Mazurek AP, Fiedor P.
    Monitoring of pancreatic islets transplanted to colon mesentery.
    Transplant. Proc. 34(2), 653-4 (2002).
  3. P. Garnuszek, J. K. Maurin, J. Witowska-Jarosz, B. Ptasiewicz-B±k
    Synthesis and characterisation of platinum(II) complexes with histamine and iodohistamine.
    Inorg. Chim. Acta 338C, 119-126 (2002).
  4. P. Garnuszek, I. Licińska
    Preliminary radiochemical and biological studies on the liposome encapsulated platinum-[125I]iodohistamine complex.
    Nucl. Med. Rev. Cent. East Eur. 5(2), 145-149 (2002).
  5. P. Garnuszek, D. Pawlak, I. Licińska, A. Kamińska
    Evaluation of a freeze-dried kit for EDTMP-based bone-seeking radiopharmaceuticals.
    Appl. Radiat. Isotop. 58(4), 481-488 (2003).
  6. P. Garnuszek, M. Maurin, J. S. Skierski, M. Koronkiewicz, J. Witowska-Jarosz
    Synthesis and Preliminary Evaluation of the New Water-Soluble Radioactive Platinum(IV) Complexes.
    J. Inorg. Biochem. 98(3), 553-559 (2004).
  7. Mirowski M., Wiercioch R., Janecka A., Balcerczak E.., Byszewska E., Birnbaum G., Byzia Sz., Garnuszek P., Wierzbicki R.
    Uptake of radiolabeled morphiceptin and its analogs by experimental mammary adenocarcinoma: in vitro and in vivo studies.
    Nucl. Med. Biol. 31(4): 451-457 (2004).
  8. P. Garnuszek.
    Marked Survival prolongation of Mice Bearing a Transplantable Colon Adenocarcinoma by Treatment with Radioactive Platinum-[125I]Histamine Complex. Preliminary Report.
    Nucl. Med. Rev. Cent. East Eur. 7(2), 113-116 (2004).
  9. Garnuszek P, Wiercioch R, Sztajer H, Karczmarczyk U, Mirowski M.
    Uptake of radiolabelled modified fragment of human alfa-fetoptrotein by experimental mammary adenocarcinoma: in vitro and in vivo studies.
    Nucl Med Rev Cent East Eur. 8(1):6-10 (2005).
  10. W. Ozimiński, P. Garnuszek, E. Bednarek, J.Cz. Dobrowolski.
    The Platinum Complexes with Histamine: Pt(II)(Hist)Cl2, Pt(II)(Iodo-Hist)Cl2 and Pt(IV)(Hist)2Cl2.
    Inorg Chim Acta 360: 1902-1914 (2007).