Automated PET Radiopharmaceutical Synthesis

Designed to streamline PET radiopharmaceutical production, the FASTlab system from GE Healthcare (Waukesha, Wis) features a single-use cassette system that accommodates different chemistries to facilitate the production of multiple PET tracers.

PET imaging is limited by both the infrastructure and expertise required for producing radiopharmaceuticals. With FASTlab, all chemicals necessary to produce FDG are preloaded in the exact quantities onto the single-use cassette. The user simply installs the cassette and pushes a button. Then, the cyclotron delivers the aqueous solution containing radioactive 18F-fluoride through a tube to the system. In 23 minutes, the FDG has been synthesized—5 minutes faster than the FASTlab’s predecessor, the GE TRACERlab MX. The progress of the synthesis can be tracked on the accompanying computer. After synthesis, the program performs a rinsing cycle; after removing the cassette, the system is available for the next run.

Currently, FDG is the only tracer to be released with the system; however, GE Healthcare is working on several new proprietary tracers, including an angiogenesis imaging agent, according to Jim Mitchell, general manager of the company’s global radiopharmacy systems unit.

With a mean uncorrected yield of 70%, the FASTlab will produce about 15% more FDG doses than the TRACERlab MX. “If a facility is currently topping out at 20 doses of FDG in one run, it could produce three more doses of FDG in the same run,” Mitchell explains. “So, if a site previously was performing an extra run on its cyclotron to produce those extra three doses, the time savings at the site could be as much as an entire cyclotron run, or about 3 hours.”

Because the FASTlab is considered manufacturing equipment by the FDA, it does not require clearance in and of itself. “Customers in the United States that choose the FASTlab system for their FDG production will ultimately need to file an NDA [new drug application] or an ANDA [abbreviated new drug application] to meet the upcoming FDA requirement for such a filing to make and distribute PET agents in the US market,” Mitchell says, noting that GE Healthcare will provide the necessary supporting documentation on the FASTlab and its cassettes for these customers’ submissions to the FDA.

The system is available for commercial sales today, with shipments beginning early in Q2 2007.

The Spec Sheet

  1. No laboratory preparation is needed before production, the setup is less than 1 minute, and there is no manual cleaning after production.
  2. All necessary chemicals are preloaded in exact quantities on the cassette.
  3. Cassettes are marked with a bar code so that the FASTlab processor reads the bar code and automatically downloads the correct parameters and batch information.
  4. Measures 51 x 41 x 44 cm (LWH), or 20.8 x 16.14 x 17.32 inches, and weighs 45 kg (99.2 pounds).

The Visible DIfference

PET imaging is one of the fastest-growing modalities in radiology today. However, to produce radiopharamaceuticals like FDG, infrastructure and expertise are required. FASTlab offers preloaded cassettes, a 23-minute synthesis process, and a 70% uncorrected yield.