PET Radiopharmacy Multitracer Platform Expands Cassette-Based Tracer Production to FDG Citrate Formulation, FMISO, and FLT

FASTlab, developed by GE Healthcare (Chalfont St. Giles, UK), offers a number of significant enhancements to address the ever-evolving challenges of tracer production. With the addition of three new cassettes, FASTlab users can access and produce fluorodeoxyglucose (FDG) phosphate formulation, NaF (sodium fluoride, fluorine-18 fluoromisonidazole (FMISO; high performance liquid chromatography [HPLC]-free), 3'-deoxy-3'-fluorothymidine (FLT; HPLC-free) and FDG citrate formulation (equivalent to TRACERlab MX standard formulation) on the same FASTlab platform. To facilitate regulatory preparation work, DMF (Drug Master Files) type V, describing the FASTlab platform, and DMF type II outlining tracer cassette and synthesis have been filed with the US Food and Drug Administration (FDA).

"Our customers tell us they need to produce PET tracers more efficiently and economically to either satisfy growing demand or to save on operating costs. Moreover, they need to meet the latest stringent regulatory standards and maintain them day after day, and they want the ability to think ahead with new PET tracers for molecular imaging applications," said Francois Roche, general manager, PET delivery, GE Healthcare.

FASTlab is an open-ended platform capable of accommodating new tracers, as they are developed, eliminating the need to buy a dedicated synthesis module to process a different tracer. The innovative hardware and user interface allows for consecutive production of different tracers on the same module. Clinicians just need to swap the cassette and the system is ready for the next tracer.

Cassettes are bar coded when loaded into the system, the processor reads the barcode and automatically downloads the right production parameters and batch information helping customers achieve CFR 212 cGMP compliance. FASTlab is also a key component of TRACERcenter, one source and one complete solution for enabling compliant PET tracer production.

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