GA-68 / LU-177

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
1 syringe driver with standard volume of 6 ml (but can be adapted to other volumes)

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:

  1. 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.
  2. 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