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A Short Success Story

B ratislava ION T echnologies. A Short Success Story. Fedor MACÁŠEK, Peter KOVÁČ BIONT, a.s., SK-84229 Bratislava, Slovakia. www.biont.sk. Overlook. Background Nuclear Medicine Radionuclides and Radiopharmaceuticals Nanotechnology Quality Management Science and Training.

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A Short Success Story

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  1. Bratislava ION Technologies A Short Success Story Fedor MACÁŠEK, Peter KOVÁČ BIONT, a.s., SK-84229 Bratislava, Slovakia www.biont.sk

  2. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management • Science and Training May 2008

  3. Positive factors (1994) • Existence of the liabilities of the Russian Federation towards Slovakia, possible for the purchase of a high-tech equipment from the Joint Institute of Nuclear Sciences, Dubna A group of nuclear physicists having contacts with the JINR Dubna Succesfull lobbing of physicists with medical doctors at state authorities The area of the former Czechoslovak federal State Institute of Metrology with obsolete buildings as a potential site for the development. May 2008

  4. Negative factors (1996-2004) • Complicated financing and managing scheme of using the liabilities of the Russian Federation towards Slovakia A lack of practical experience of the involved Slovak and even Russian nuclear scientists community with such type of multipurpose project „Pseudo-green“ lobbing of some NGOs against the installation of cyclotron facility A very lengthy implementation period. May 2008

  5. May 2008

  6. SMU 3 Cyclone 18/9 PET Radiopharmaceuticals SMU 4 A state-owned share-holding company established January 2005 BIONT 1 SMU 2 SMU 5 BIONT 2 BIONT 3 SUTN 2 SNAS SMU 1 SUTN 1 SMU 6 SMU 7 Area of the Slovak Institute of Metrology May 2008

  7. 72MeV multi-purpose cyclotron DC 72 10MeV cyclotron for PET radionuclides in the same building 72MeV cyclotron in abuilding „J“. 18MeV PET cyclotron in building „I“, May 2008

  8. Cyclone 18/9 Pavil. „I“ DC 72 Pavil. „J“ May 2008

  9. Technical Milestones May 2008

  10. A very important help: IAEA Technical cooperation task SLR/2/002Radiochemical Facilities for Producing Medical Radionuclides 1994-2004IAEA Officers: H. Vera-Ruiz, A. AtgerSR Liaison Person: Fedor Macášek

  11. Visits and fellowships supported by IAEA May 2008

  12. Strong Need of IAEA Expertise • Dr. R.M.LAMBRECHT, Brookhaven • Dr. J.LINCKE, Dresden • Dr. F.MELICHAR, Řež • Dr. D.SCHLYER, Brookhaven • Prof. O. SOLIN, Turku • Dr. J.ŠTURSA, Řež • Dr. F.TARKÁNYI, Debrecen • Prof. W.VAALBURG, Gröningen • Dr.H.VERA-RUIZ, IAEA • Dr. V.E.BECHTOLD, Karslruhe • Prof. G.BEYER, Geneva • Dr. J.C.CLARK, London • Prof. G. HÖR, Frankfurt • Prof. T.IDO, Tohoku • Dr. Y.JONGEN, Louvain-la-Neuv • Dr. B.O.KNOOP, Hamburg • Dr. P.KOPECKÝ, Prague May 2008

  13. 2004 October 27th, Government’s resolution No. 1003/2004 BIONT, a. s. (Bratislava Ion Technologies) A joint-stock company, established since January 21st, 2005 from the parts of CC SR finished as the first phase of the project Registered capital: 1.056 billion SKK (about 32 mil. EUR) Stock Holders • Ministry of Education of the Slovak Republic • Ministry of Health Care of the Slovak Republic • Ministry of Economy of the Slovak Republic • Ministry of Defence of the Slovak Republic • Slovak Office of Standards, Metrology and Testing May 2008

  14. We have experienced(somehow expected) • negative attitude of local public, • toughening oflegislation and inspection, • lack of the technology adequate to rigorous aseptic production and radiation safety, • personnel shortage in pharmaceutical branches, • some mistrustfulness of physicians. May 2008

  15. We have experienced(somehow unexpected) a serious delay in the stocks distribution among stockholders, three (!) proposals of a government resolution expressing doubts on establishment of BIONT as a commercial, state owned private company, just a weak, if any, interest of our stockholders in our development projects (like the animal tomography or the training of future operators of cyc;lotron facilities and RP production). Still, the enthusiastic staff of BIONT worked towards a high qualification of the company...

  16. We have experienced(somehow unexpected) … and after all, according the resolution of the Slovak Governement Nr. 322/2008 from May 21st, 2008, 95% of shares of the company should be transferred to Ministry of Education of the Slovak Republic, and the rest to the Slovak Office of Standards, Metrology and Testing. Our position may become more favourable for both routine production and development programs.

  17. May 2008

  18. May 2008

  19. Basic indicators (mil. SKK ≈ 33 k€) * Earning before interest, taxes, depreciation and amortizanion May 2008

  20. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management • Science and Training May 2008

  21. Nuclear medicine practice Over 3000 patients investigated since September 2005 Clinical trials contracted since January 2008 Millennium Hawk Eye (GE) SPECT/CT Discovery LS(GE) PET/CT May 2008

  22. PET/CT scan Discovery LS (GE - 2001) CT tomograph PET tomograph Picture merge May 2008

  23. Nuclear medicine diagnostics To the end of May 2008 • with the help of [18F]FDG radiopharmaceutical, 2930 patient from Slovakia and abroad havce been investigated by PET/CT • 1380 patients were investigated by other nuclear medicine techniques on SPECT/CT camera May 2008

  24. microPET / pre-clinical studies eXplore Vista laboratory animal PET Scanner (GE) May 2008

  25. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management May 2008

  26. „After 25 y of advances in cyclotron targetry, radiotracer chemistry, automation, and the tireless efforts of many who shepherded FDG through the regulatory maze, FDG is just a phone call away, supplied to local hospitals by regional distribution centers. This should inspire chemists to develop the next FDG-like molecules, which will be widely available and can broaden our understanding of the molecular basis of the major illnesses facing humanity, including cancer, diseases of the brain (including addiction and neurodegenerative disorders), and other medical problems for which lack of knowledge has limited treatment.“ Joanna Fowler, (2001) May 2008

  27. Cyclotron and Targetry Cyclone 19/8 (IBA) with external beam May 2008

  28. Targetry Standard IBA liquid targets for 18F- (Ag,Nb body), gaseous 18F2 and 11CO2, an upgrade of Nb target and 11CH4 target, and a solid target COSTIS Targets for 15O2, 13NH3 are not used at present . May 2008

  29. Cyclotron and Hot Cells Capilary distribution system (SAS – Tema Sinergie) between 6-8 targets and 6-8 shielded cells and a PET/CT tomograph May 2008

  30. Shielded cells Tema Sinergie Hans Wälischmiller Clean rooms R&D May 2008

  31. Synthesis modules • TRACERlab FXFDG • TRACERlab MXFDG • TRACERlab FXDOPA • TRACERlab FXC • NH3 module IBA May 2008

  32. Commercial production The technology for radionuclides production involves: • [18F]FDG (routine production by TRACERlab MXFDG module, 50-80 GBq per run), • [11C]CH3I / [11C]methionine – validation synthesis(1-4 GBq per run) • [18F]DOPA / [11C]raclopride – pilot synthesis,

  33. Commercial production The production of [18F]FDG radiopharm-aceutical for cancer diagnostics was launched commercially since February 2006 under the licence of the Nuclear Physics Institute of the Academy of Sciences of the Czech Republic (Řež near Prague), with product distribution both in the Slovak and Czech republics. To the end of May 2008, production units ensured 987 commercial deliveries of [18F]FDG at average activity 4.3 GBq at customer reference time. May 2008

  34. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management • Science and Training May 2008

  35. ECR ion source DECRIS 2M May 2008

  36. ECR ion source DECRIS 2M May 2008

  37. Scanning probe microscope Scanning probe microscope SPM Solver P47.Measuring modes: • STM – scanning tunnelling microscopy • AFM – atomic force microscopy, • MFM - magnetic force microscopy • EFM - electrostatic force microscopy • SCM - scanning capacitance microscopy, • Nano-lithography May 2008

  38. Ion implanatation May 2008

  39. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management • Science and Training May 2008

  40. Harmonisation of the regulations in the radiopharmaceuticals production radiation safety drug sterility Health Protection Act Drug Administration Act environmental impact enduser protection Quality Managment ISO 9001 Environment Protection Act May 2008

  41. The legislative challenges (2001-2004) • EC Directives 99/11, 99/12, 2001/83, 2003/94, and 2004/27 • ICH Q7A Guidance for Good Manufacturing Practice. • GAMP4 Guide for Validation of Automated Systems, ISPE 2000. • Slovak Republic Radiation Protection Act 470/2000. • Slovak Republic Health Care Acts 272/1994 and 576/2004. • Slovak Republic Drug Control Acts 140/1998 and 663/2004. May 2008

  42. Radiation safety monitoring May 2008

  43. Corporal manufacturing IS May 2008

  44. Production dependability May 2008

  45. Quality Management ISO 9001:2000 May 2008

  46. Overlook • Background • Nuclear Medicine • Radionuclides and Radiopharmaceuticals • Nanotechnology • Quality Management • Science and Training May 2008

  47. Science and Training Grants: • EC 6th Framework Program, Integrated Project IP-515803-2 CHARPAN Charged Particles Nanotech. • APVT–20–011804 Multifunctional oxide layers. • APVT–20–0034404 Development of superhard materials based on carbide and nitride layers, accenting the diamond and cubic boron nitride. • APVT-51-016604 Superconductors for future technologies. • AV 4/0037/07 Preparation of the submicro- and nanometric structures using sophisticated lithographic methods. • APVV-51-01705 Neuroprotective action of new pyridoindol antioxidants. • APVV-058606 Epigenetic risk factors of cerebral infarct. May 2008

  48. Science and Training Staff: 60% university degree 30% PhD and DrSc May 2008

  49. Conclusion BIONT is a SME facility fully compliant with medical applications of cyclotron radionuclides and open for both the scientific and commercial co-operation in the healthcare sphere. Favorable conditions were created for a complex training of personnel in current good practices and relevant quality management systems, the qualified persons for PET radiopharmaceuticals automated production in particular. May 2008

  50. With thanks to our managing colleagues: PharmDr. Zlatica Cesnaková RNDr. Daniel Baček Assoc.Prof. Vladimír Gašparík, PhD Dipl.Ing.Zoltán Kassai, PhD Mgr. Erzsébet Losonczi Pataky Pavol Povinec, M.D., PhD Prof.Pavol Rajec, PhD, DrSc Dipl.Ing. Jozef Staňo, PhD Dipl.Ing.Ondrej Szöllős, PhD Svorad Štolc, M.D., DrSc Dipl.Ing. Ivan Vereš

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