1. Radiochemistry Solutions

2. 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

3. A broad range radiochemistry offering
Explora FDG4
Quality FDG production
Explora CN
Cyanide synthesis
Explora GPU
Gas processing
Explora AC
Produces acetate
Explora H2O
15O water module
Explora FDG4
Explora CN
Explora AC
Explora H2O

4. Explora FDG4 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)

5. Explora FDG4 – 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 number
Synthesis yield
Total FDG 1
81%
6760 mCi 2
77%
5520 mCi 3
78%
6440 mCi 4
69%
5070 mCi
4 runs
76% average
23790 mCi total
Daily Usage

6. 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

7. 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

8. 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

9. Explora summary The superior choice Reliable Powerful Convenient Smart
Inexpensive
Flexible
Safe
The superior choice

10. Explora AC – 11C Acetate module
Produces 11C acetate and other Grignard tracers.
Fully automated with high yields
Decay corrected yields >70%

11. Explora CN – 11C Cyanide module
For producing 11C amino acid precursors
Produces high yields of 11C HCN or 11C CH4
Decay corrected yields >55%

12. Explora H2O – 15O Water module
Provides inexpensive unit doses of 15O labeled water
Disposable cartridge
Self shielded
Simplified siting
Can be placed next to scanner bed

13. Explora GPU – Gas processing unit
For the production of 15O and 11C gases
15O2 C15O, C15O2
11CO2 11CO
Flow chemistry
No minicells needed
Placed inside the cyclotron shields

14. Newly introduced chemistry modules
Explora GN
For general nucleophilic reactions including FLT
Explora GPC
Methyl iodide synthesis
Explora CH3
Methylation module
AND
Two new purification modules
Explora FM
Explora LC
Explora GN
Explora GPC
Explora CH3
Explora FM
Explora LC

15. Explora GN – Built on the reliability and efficiency of FDG4
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)

16. Explora GN application flexibility
Synthesis and purification options
Seamless integration to purification modules
Explora GN
Explora FM
Explora LC
FDG
F-MISO
NaF
FLT

17. Explora GPC – Versatile solution for methyl iodide synthesis
Key Features
Flexible and completely automated module for gas phase synthesis of 11C methyl iodide
Consistently generates high specific activity methylating agents
Capable of accepting 11C CO2 or 11C 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 11C methyl iodide and releases only when ready for subsequent steps
Capable of 15 runs between refilling / reconditioning of 11C methyl iodide

18. Methyl iodide synthesis – the “traditional” method
Unintended and undesirable accumulation leading to component failure
Intended accumulation leading to frequent servicing
Intended depletion leading to frequent servicing
Methyl iodide trap
Unintended and undesirable accumulation leading to frequent servicing
Time for service!

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

20. Explora CH3 - Methylation module
Key Features
Uses solvent-based chemistry for production of 11C methylated compounds
Can be used in combination with Explora GPC
Can accept various 11C methylating intermediates in gas phase from other sources

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

22. 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