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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Bratislava ION Technologies
A Short Success Story
Fedor MACÁŠEK, Peter KOVÁČ
BIONT, a.s., SK-84229 Bratislava, Slovakia
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.
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.
A state-owned share-holding company established January 2005
Area of the Slovak Institute of Metrology
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“,
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
Visits and fellowships supported by IAEA
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)
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...
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.
* Earning before interest, taxes, depreciation and amortizanion
Over 3000 patients investigated since September 2005
Clinical trials contracted since January 2008
Millennium Hawk Eye (GE) SPECT/CT
(GE - 2001)
To the end of May 2008
eXplore Vista laboratory animal PET Scanner (GE)
„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.“
Cyclone 19/8 (IBA) with external beam
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 .
Capilary distribution system (SAS – Tema Sinergie)
between 6-8 targets and 6-8 shielded cells and a PET/CT tomograph
The technology for radionuclides production involves:
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.
ECR ion source DECRIS 2M
Scanning probe microscope
Scanning probe microscope SPM Solver P47.Measuring modes:
Health Protection Act
Drug Administration Act
Environment Protection Act
60% university degree
30% PhD and DrSc
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.
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
and with thanks to your attention!