For internal use only / Copyright © Siemens AG 2006. All rights reserved. Radiochemistry Solutions.

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Presentation transcript:

For internal use only / Copyright © Siemens AG All rights reserved. Radiochemistry Solutions

Innovation is in our genes. 2 Siemens Healthcare Molecular Imaging Leadership in radiopharmaceuticals production Total Solution Provider  Eclipse: Upgradeable cyclotrons  Explora: Full line of radiochemistry modules  Start up and continued support for current and future growth

Innovation is in our genes. 3 Siemens Healthcare Molecular Imaging A broad range radiochemistry offering  Explora FDG 4 Quality FDG production  Explora CN Cyanide synthesis  Explora GPU Gas processing  Explora AC Produces acetate  Explora H 2 O 15 O water module Explora FDG 4 Explora CN Explora AC Explora H 2 O

Innovation is in our genes. 4 Siemens Healthcare Molecular Imaging Explora FDG 4 specifications  45 minute synthesis  75% decay corrected yield  4 runs without intervention  Novel recipe building software  Remote diagnostic capability  Automatic self-cleaning  Rich user feedback (radiation, temperature, pressure sensors)  Low cost of operation  Minimal custom parts (uses conventional disposable glassware)

Innovation is in our genes. 5 Siemens Healthcare Molecular Imaging Explora FDG 4 – Multirun synthesis module Convenient - Smart - Reliable  4 runs without intervention  Remote diagnostic capability  Automatic self-cleaning  Rich user feedback (radiation, temperature, pressure sensors)  Low cost of operation Run numberSynthesis yield Total FDG 181%6760 mCi 277%5520 mCi 378%6440 mCi 469%5070 mCi 4 runs76% average23790 mCi total Daily Usage

Innovation is in our genes. 6 Siemens Healthcare Molecular Imaging Explora convenient  4 runs without intervention  Set up once, run all day  Kits are available for streamlined setup  Reagents are inverted on disposable spikes  No measurement of reagents – All calculations are performed automatically via software

Innovation is in our genes. 7 Siemens Healthcare Molecular Imaging Explora smart  Everything you need to know to optimize performance  Feedback of temperature, pressure, radiation  All data recorded for playback can see performance in trapping, labeling, hydrolysis  Synthesis data synopsis guides performance improvement  Remote operation and test capability  Software speaks like, and understands, chemists

Innovation is in our genes. 8 Siemens Healthcare Molecular Imaging Explora reliable  4 runs/day with > 20 Ci production yield of FDG  Has been utilized to make over 8 Ci of FDG in a single run  Has made over 150,000 batches of FDG in PETNET commercial pharmacies  40% more likely than other commercial systems to provide yields over 75%  > 99% uptime Raw data from PETNET network records October 2004 – Mar 2008

Innovation is in our genes. 9 Siemens Healthcare Molecular Imaging Explora summary  Reliable  Powerful  Convenient  Smart  Inexpensive  Flexible  Safe The superior choice

Innovation is in our genes. 10 Siemens Healthcare Molecular Imaging Explora AC – 11 C Acetate module  Produces 11 C acetate and other Grignard tracers.  Fully automated with high yields  Decay corrected yields >70%

Innovation is in our genes. 11 Siemens Healthcare Molecular Imaging Explora CN – 11 C Cyanide module  For producing 11 C amino acid precursors  Produces high yields of 11 C HCN or 11 C CH 4  Decay corrected yields >55%

Innovation is in our genes. 12 Siemens Healthcare Molecular Imaging Explora H 2 O – 15 O Water module  Provides inexpensive unit doses of 15 O labeled water  Disposable cartridge  Self shielded  Simplified siting  Can be placed next to scanner bed

Innovation is in our genes. 13 Siemens Healthcare Molecular Imaging Explora GPU – Gas processing unit  For the production of 15 O and 11 C gases  15 O 2  C 15 O, C 15 O 2  11 CO 2  11 CO  Flow chemistry  No minicells needed  Placed inside the cyclotron shields

Innovation is in our genes. 14 Siemens Healthcare Molecular Imaging Newly introduced chemistry modules  Explora GN For general nucleophilic reactions including FLT  Explora GPC Methyl iodide synthesis  Explora CH 3 Methylation module AND Two new purification modules  Explora FM  Explora LC Explora GNExplora GPC Explora FM Explora LC Explora CH 3

Innovation is in our genes. 15 Siemens Healthcare Molecular Imaging Explora GN – Built on the reliability and efficiency of FDG 4  Compatible with most nucleophilic solvents  Capable of delivering small reagent volumes with virtually no loss – cost benefit when using expensive precursors  Option to synthesize FDG  New software supports pressurized reaction steps  Integrates with semi-prep HPLC modules (Explora LC) and formulation module (Explora FM)

Innovation is in our genes. 16 Siemens Healthcare Molecular Imaging Explora GN application flexibility FDG F-MISO NaF FLT  Synthesis and purification options  Seamless integration to purification modules

Innovation is in our genes. 17 Siemens Healthcare Molecular Imaging Explora GPC – Versatile solution for methyl iodide synthesis Key Features  Flexible and completely automated module for gas phase synthesis of 11 C methyl iodide  Consistently generates high specific activity methylating agents  Capable of accepting 11 C CO 2 or 11 C methane gas  Provides continual feedback to user via comprehensive monitoring via radiation detectors, iodine vapor density tracking, mass flow controller monitoring and feedback, pressure transducer trace and multiple temperature readouts  Concentrates and traps 11 C methyl iodide and releases only when ready for subsequent steps  Capable of 15 runs between refilling / reconditioning of 11 C methyl iodide

Innovation is in our genes. 18 Siemens Healthcare Molecular Imaging Methyl iodide synthesis – the “traditional” method Methyl iodide trap Unintended and undesirable accumulation leading to component failure Unintended and undesirable accumulation leading to frequent servicing Intended accumulation leading to frequent servicing Intended depletion leading to frequent servicing Time for service!

Innovation is in our genes. 19 Siemens Healthcare Molecular Imaging “Improved” methyl iodide synthesis – The Siemens method Key advantages - Intervention into the device is minimized, thereby providing  High uptime  Low personnel dose  Very high specific activity Methane in Methyl Iodide out

Innovation is in our genes. 20 Siemens Healthcare Molecular Imaging Explora CH 3 - Methylation module Key Features  Uses solvent-based chemistry for production of 11 C methylated compounds  Can be used in combination with Explora GPC  Can accept various 11 C methylating intermediates in gas phase from other sources

Innovation is in our genes. 21 Siemens Healthcare Molecular Imaging Explora FM – Formulation module Key Features  Performs solid phase extraction (SPE) purification for final product formulation  Capable of being setup for production of 18 F NaF  Flexible recipe builder software allows end user to design customer purification schemes

Innovation is in our genes. 22 Siemens Healthcare Molecular Imaging Explora LC – Semi-prep HPLC purification module Key Features  Semi-prep or analytical radio-HPLC for purification of crude radiopharmaceuticals  Novel loop loading method without using problematic bubble detectors  Back-to-back run capability  Automated column switching  Automated column cleaning – no manual solvent switching  Automated fraction collection via either UV signal or radiation detection  Control software complies to the guidelines specified in the 21 CFR Part 11 for the storage and protection of electronic archived data and electronic signatures.  Product includes HPLC pump, UV and radiation detector, solvent switching valve, fraction collection valve and loop loading valve with 2 loop positions