Multi-Tracer Platform Expands Cassette-Based Tracer Production to FDG Formulation
To facilitate regulatory preparation work, DMF type V, describing the platform, and DMF type II, outlining tracer cassette and synthesis, have been filed with the FDA.
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 barcoded — 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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