GE Healthcare

FASTlab*

FLT cassette with integrated reagents Data Sheet

ApplicationFASTlab FLT cassettes allow the production of the [18F]-3-Fluoro-thymidine also known as the PET research agent [18F] FLT.

The application is supplied for the FASTlab equipment. [18F] Fluoride is produced by a cyclotron (for example GE PETtrace* or MINItrace*) and converted into [18F] FLT in less than an hour.

FLT is purified by solid phase extraction cartridges (SPE). Therefore FASTlab can be used stand alone without additional HPLC equipment.

Features Integratedcassettesloadedwithreagents.

TheDMTr-Boc-NosylFLTprecursorvialissuppliedseparatelyas it has to be stored in freezer while the rest of the cassette can be stored at room temperature. The precursor vial has to be inserted in the cassette before starting the production.

CassettessuppliedbyGEHealthcarearemanufacturedina controlled environment and include reagents manufactured under cGMP standards with precise quantities and formulations. They are accompanied by a Certificate of Analysis.

CassettessuppliedbyGEHealthcarearetestedforbioburden and bacterial endotoxins.

Cassettesaremarkedwithabarcodeforautomatic identification and recovery of batch information. The barcode also ensures that the optimal synthesis parameters for [18F]-FLT are automatically loaded.

Allpartsandcomponentsincontactwiththechemicalsare replaced at every run ensuring clean operation.

FLT chemical process The precursor is labelled by nucleophilic substitution of nosylate group by [18F]- Fluoride. The resulting labeled precursor is deprotected by an acidic hydrolysis with phosphoric acid leading to [18F]-FLT in organic/aqueous solution. The [18F]-FLT is subsequently trapped on a reverse phase extraction cartridge for pre-purification. The [18F]-FLT is then purified, eluted and formulated into the final product collection vial with ethanol/water solution.

The tracer is then ready for final sterile filtration, dispensing and quality control.

Cassette suppliesCassettes (to be used on S9170AA FASTlab multitracer platform) are supplied with all the components and reagents needed for the production of [18F]-FLT (except enriched water).

P5370JLFASTlabFLTcassettepackintegratedwithreagents and separate precursor vial box

P5370KFFASTlabproductcollectionaccessoriesincludinga sterile product collection vial, a sterile product filter, a sterile vent filter and 2 sterile needles

Shelflife=3months(willbeextendedbasedonstabilitydata)

Storageconditionforthecassette:roomtemperature

Storageconditionfortheprecursorvial:tobekeptinfreezer

Note:The use of such cassettes to produce [18F]-FLT for injection to human bodies is the sole responsibility of the user. GEHC is not liable for any adverse effect that might

occur during of or after such use.

System performance for FLT synthesis

Technical data

Cassette set up time