Lutetium-177 (177LuCl3)
Intended use: Treatment of neuroendocrine tumors with metastases. The drug is administered intravenously. Also, the patient receives a protective medicine to reduce the radiation load. The drug has a strong effect on destroying cancer cells. In some cases, complete recovery occurs, but in general, Lu-177 is used to remove clinical manifestations of cancer.
Specifications of Lutetium-177 (177LuCl3)
|
Appearance |
Clear, colorless |
|
Radionuclide Identification |
A major photo peak at 0.208 MeV |
|
Radioactive concentration, Ci/ml (GBq/ml) |
Not less than, 1.0 (37.0) |
|
Specific activity, Ci/mg (GBq/mg) |
Not less than, 81.08 (3000) |
|
Radionuclide. Purity, other gamma impurities, % |
>99.9 |
|
Radionuclide. Purity, other gamma impurities, (58Co, 60Co, 65Zn, 54Mn, 59Fe, 51Cr) % |
0 (The lack of Co-58, 60Co, 65Zn, 54Mn, 59Fe, 51Cr is guaranteed by the production technology) |
|
175Yb to 175Lu activity ratio, % |
Not more than 1*10-6 |
|
The total content of inactive impurities Fe, Cu, Zn, Pb, 176Yb |
Not more than 0,1 µg/ml |
|
Solvent (hydrochloric acid) concentration, mol/l |
0,04 |
|
pH |
1.4-1.5 |
|
Radiochemical purity |
Not less than 98% |
|
Expiration date |
21 days |
|
Endotoxin level |
Not more 0.25 IU/ml |
|
Sterility |
Sterile |
68Ga Cyclotron Liquid Targets: ZN-68 I.E.>99%
Intended use: target material for cyclotron irradiation and production of radionuclide Ga-68.
Specifications of Zn-68
|
Modes of production |
Gas centrifugal/electromagnetic |
|
Chemical form |
Metal (Zn), oxide (ZnO), (powder, tablets), acetate (Zn(CH3COO)2x2H2O) |
|
CMR isotope enrichment |
>99.00% |
|
Chemical purity |
>99.9% |
|
Atom natural content |
18.75% |
68Ga/177Lu Module Synthesis
Synthera® extension/ Peptide labelling version
Synthera® extension - Peptide labelling version is a compact chemistry module, designed to extend IBA Syntera® modules family capability for theranostic radiopharmaceutical applications and peptide labelling:
- 68Ga-PSMA, 68-GA-DOTANOC,
… and correspondent theranostic pairs: - 177Lu-PSMA, 177Lu-DOTANOC, …
Based on conventional IBA® Synthera® Extension employs re-usable support cassette (without direct chemical contact) where a disposable tubing kit can be placed.
This support cassette can be customized to include other components such as columns, filters or vial holders depending on the user’s application. The result is a cost-effective solution that eliminates the need of expensive disposable consumables. Synthera® Extension – peptide labelling version is equipped with vial heater to ensure high labelling yields.
All applications developed for Synthera® Extension standalone module are available, including 18F-NaF, 13N-NH3 and 99mTc-pertechnetate as well as research-oriented tasks such as purification of 89Zr, 68Ga and 64Cu, to obtain 89Zr-oxalate, 68Ga-chloride and 64Cu-chloride, respectively.
Technical Data
Applications |
Equipment required |
Consumables Reference* (Quantity Required Per Run) |
||
|---|---|---|---|---|
Synthera®Extension |
Cassette Support (Reusable) |
Tubing Kit |
Reagents and ancillaries Kit |
|
|
68Ga-DOTANOC,68Ga-PSMA,68Ga-others |
1 |
03.003 (1) |
02.003 (1) |
04.003 (1) |
|
177Lu-DOTANOC, 177Lu-PSMA |
1 |
03.063 (1) |
02.063 (1) |
04.063 (1) |
|
18F-NaF |
1 |
03.010 (1) |
02.010 (1) |
- |
|
13N-NH3 |
1 |
03.020 (1) |
02.020 (1) |
- |
|
99mTc-pertechnetate |
2 |
** |
** |
** |
|
89Zr-oxalate, 68Ga-chloride and 64Cu-chloride |
1 |
*** |
*** |
*** |
*Fluidomica reference numbers, ** under development, ***Check for Specific Technical Data Sheet
Main Features
|
Synthera® Hardware |
10 independent pinch valves One inert gas line with pressure regulator, pressure sensor & solenoid valve. 5 fixed versatile internal ETFE lines (allowing to connect elements such as waste bottle, vent-line, recovery bottle, rinsing liquid feed). Hold points for customization. Reactor heater for 10ml vials. |
|
Consumables |
Re-usable cassette able to support fluidic lines and other components (but not in direct contact with the chemical synthesis) Disposable Tubing kits recommended: 02 product family of Fluidomica, refer to application guide |
|
Auxiliary port |
Auxiliary digital input/output & auxiliary analog input |
|
Synthera® Extension Software |
Included in Synthera® Software platform; Open Software platform; PLC-assisted; ©GMP compliant; Microsoft® Windows interface |
68Ga/177Lu Cassettes & Tubing
The fully automated synthesis system IBA Synthera® Extension PLV works with sterile, disposable synthesis tubing kits installed in a dedicated cassette support, ensuring simple and reliable handling through technology. No recondition and cleaning or sanitation routines are necessary, due to disposable single use kits.
Disposable tubing kits and cassette support available for 68Ga/177Lu labelling
Part type |
Fluidomica reference no. |
Typical synthesis time |
|---|---|---|
|
Cassette support for 177Lu-peptide labelling with C18 post purification (Reusable*) |
03.063* |
- |
|
Cassette support for 177Lu-peptide labelling with no post purification (Reusable*) |
03.064* |
- |
|
Cassette support for 68Ga-peptide labelling with C18 post purification (Reusable*) |
03.003* |
- |
|
Tubing kit for 177Lu-peptides with C18 post purification |
02.063 |
30 min |
|
Tubing kit for 177Lu-peptides with no post purification |
02.064 |
30 min |
|
Tubing kit for 68Ga-peptides with C18 post purification |
02.003 |
20 min |
*The support cassette is not in direct contact with product
Part type |
Fluidomica reference no. |
|---|---|
|
Kit for 177Lu-peptides with C18 post purification |
04.063 |
|
Kit for 177Lu-peptides with no post purification |
04.064 |
|
Kit for 68Ga-peptides with C18 post purification |
04.003 |
Peptides
Intended use: chemical precursors for manufacturing of radiopharmaceuticals.
CMR offers two main groups of peptide products:
- PSMA-ligands (inhibitors) – pharmacological activity is provided with specific interaction with prostate-specific membrane antigen (PSMA). PSMA is cell surfaced enzyme, highly expressed on prostate cancer cells and has low or no expression in other cells, and, therefore, becomes a unique target for nuclear medicine.
- Octapeptide analogues of somatostatins – for labeling have the pharmacological effects due to their structural mimic of the endogenous hormone somatostatin. Basically, they are used for imaging and treatment of neuroendocrine tumors.
Training & Service
Our PhD specialists are always ready to answer all of your questions regarding Ga-68 production on your cyclotron, Lu-177 and Ga-68 labelling with all kind of Peptides. For installation of module synthesis, our consultants will visit you with professional training and sharing experience.
Proposal program
Task № |
Task |
Days on site |
Notes |
|---|---|---|---|
|
1 |
Arrive on site; familiarize with facilities; schedule installation and training program with site team |
0.5 |
|
|
2 |
Installation of the system |
0.5 to 1 |
|
|
3 |
IQOQ of system |
0.5 |
|
|
4 |
Preliminary runs (up to max 3) |
0.5 to 1 |
Could be a cold-runs of with activity |
|
5 |
Training of staff |
1 to 1.5 |
Dependent on number of people to train |
|
6 |
Hot runs for validation |
1 to 1.5 |
|
|
7 |
Final acceptance off installation |
0.5 |
|