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Radiochemistry Center
The main goal of the Radiochemistry Center is to provide radiopharmaceuticals for the routine PET investigations and as well for various research projects.
To achieve this goal the center has 7 chemist (2 PhD, 1 dr. univ.) and 4 technicians.
The radioisotopes required for the pharmaceuticals and labeled compounds are produced by a GE made PETtrace cyclotron. On table 1 the parameters of the cyclotron, on table 2 the available radioisotopes can be seen.
Protons | 16,5 MeV/100 µA |
Deuterons | 8 MeV/40 µA |
Targets | 2x High yield 18F- target (170GBq) 2x Second generation 18F- target (<200 GBq) 2x Second generation (Nb) 18F- target (<200 GBq) 13N/18F target (100 GBq 18F) 15O target 11C target |
Isotope | 15O | 11C | 13N | [18F]F |
T1/2 (perc) | 2.05 | 20.39 | 9.96 | 109.8 |
Nuclear reaction | 14N(d,n)15O | 14N(p,a)11C | 16O(p,α)13N | 18O(p,n)18F |
Target material | 99 % N2 1% O2 |
99 % N2 1% O2 |
[16O]water | [18O]Water |
Product | 15O2 | 11CO2/11CO | 13NH3 | [18F]F- |
Producible activity | 74 GBq (2 Ci) | 111GBq (3 Ci) | 15 GBq (0,4Ci) | >200 GBq (>6 Ci) |
The radiopharmaceuticals are produced in a GMP compatible laboratory, where 8 synthesis cells and 2 dispensing cells had been installed. The laboratory got the GMP certificate in 2007 what gives it right to produce routine and investigational radiopharmaceuticals.
For development work five hot cells can be used in two laboratories. These hot cells are shared with the radiochemistry research group.
In table 3 the equipments available for radiopharmaceutical production are listed.
We had established a „radiopharmaceutical shelf" for this purpose (table 4) .
Item | Made by | Remarks | Quantity |
FDG module | Nuclear interface / GE Healthcare | Tracerlab FXFDG | 4 |
Electrophil fluorination module | GE Healthcare | Tracerlab FXFE | 1 |
Metil iodide module | GE Healthcare | MEI Microlab | 1 |
FDG module | Nuclear Interface | (Borrowed from Charite Hospital of Humbold University/Berlin | 1 |
Methionin production module | home made | for routine production | 1 |
11C MeI modul | Made by a cooperation between Hamburg and Debrecen | under construction | 1 |
Dispenser for FDG | Veenstra Instruments | DSP101 | 1 |
Dispenser for other raiopharmaceuticals | Home made | based on a gilson liquid handler | 1 |
Dispenser for other raiopharmaceuticals | MediRoll Ltd, by our design and specification | uses only steril single used tubing and disposables | 1 |
HPLC | various | 7 | |
GC | Perkin Elmer | 2 | |
TLC scanner | Raytest | MiniGita | 1 |
Metabolic processes | Blood flow | Receptor specific | |
Routine diagnostics | [18F]FDG [11C]methionine ([11C]choline) |
([15O]butanol) | |
Research support | [18F]FLT [18F]FAZA [11C]Verapamil |
[15O] water [13N] NH3 [14O] butanol |
[18F]fallypride [18F]desmetoxi-fallypride [11C]PIB |
Own development | [18F]NECA [11C]CSC [11C]ISC |
In this shelf the labeled materials are divided in three groups. In the first group the routine radiopharmaceuticals are shown. In this group our main product is the FDG what was first registered by 1994 at the National Institute of Pharmaceuticals. When Hungary had joined to the European Union this registration had been upgraded to Marketing Authorization. FDG is used in the laboratories of the Scanomed Ltd in Debrecen and Budapest. We regularly deliver this radiopharmaceutical to Bulgaria and Romania as well. The production rate of FDG is rising from year to year; last year it exceeded the 9000 patient doses per annum. These deliveries give us a confidence and experience for regular high quality radiopharmaceutical production. The second routinely used RP is the C-11 methionine. According to the Hungarian law about pharmaceuticals this also has Marketing Authorization, despite it can be use only in Debrecen. For the same reason the dossier for C-11 choline in under preparation.
Besides of the routine radiopharmaceuticals several other tracers are available. for the beginning we prepared the most popular ones, later others could be added upon demand.