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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

www.biont.sk


Overlook
Overlook

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

  • Science and Training

May 2008


Positive factors 1994
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


Negative factors 1996 2004
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



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


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


Cyclone 18/9

Pavil. „I“

DC 72

Pavil. „J“

May 2008



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



Strong need of iaea expertise
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


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


We have experienced somehow expected
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


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.




Basic indicators mil skk 33 k
Basic indicators (mil. SKK ≈ 33 k€)

* Earning before interest, taxes, depreciation and amortizanion

May 2008


Overlook1
Overlook

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

  • Science and Training

May 2008


Nuclear medicine practice
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


Pet ct scan
PET/CT scan

Discovery LS

(GE - 2001)

CT tomograph

PET tomograph

Picture merge

May 2008


Nuclear medicine diagnostics
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


Micropet pre clinical studies
microPET / pre-clinical studies

eXplore Vista laboratory animal PET Scanner (GE)

May 2008


Overlook2
Overlook

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

May 2008


„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


Cyclotron and targetry
Cyclotron and 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

May 2008


Targetry
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.“

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


Cyclotron and hot cells
Cyclotron and Hot Cells 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.“

Capilary distribution system (SAS – Tema Sinergie)

between 6-8 targets and 6-8 shielded cells and a PET/CT tomograph

May 2008


Shielded cells
Shielded cells 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.“

Tema Sinergie

Hans Wälischmiller

Clean rooms

R&D

May 2008


Synthesis modules
Synthesis modules 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.“

  • TRACERlab FXFDG

  • TRACERlab MXFDG

  • TRACERlab FXDOPA

  • TRACERlab FXC

  • NH3 module IBA

May 2008


Commercial production
Commercial production 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.“

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,


Commercial production1
Commercial 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.“ 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


Overlook3
Overlook 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.“

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

  • Science and Training

May 2008


Ecr ion source decris 2m
ECR 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.“ion source DECRIS 2M

May 2008


ECR 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.“ion source DECRIS 2M

May 2008


Scanning probe microscope 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.“

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


Ion implanatation
Ion implanatation 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.“

May 2008


Overlook4
Overlook 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.“

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

  • Science and Training

May 2008


Harmonisation of the regulations in the radiopharmaceuticals production
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


The legislative challenges 2001 2004
The legislative challenges production(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


Radiation safety monitoring
Radiation safety monitoring production

May 2008


Corporal manufacturing i s
Corporal productionmanufacturing IS

May 2008


Production dependability
Production dependability production

May 2008


Quality man a gement
Quality Man productionagement

ISO 9001:2000

May 2008


Overlook5
Overlook production

  • Background

  • Nuclear Medicine

  • Radionuclides and Radiopharmaceuticals

  • Nanotechnology

  • Quality Management

  • Science and Training

May 2008


Science and training
Science and Training production

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


Science and training1
Science and Training production

Staff:

60% university degree

30% PhD and DrSc

May 2008


Conclusion
Conclusion production

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


With thanks to our managing production 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! production

[email protected]


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