As part of a commitment to support continued growth in the positron emission tomography (PET) and PET/ Computed Tomography (CT) imaging industry that would enable more patients access to care, PETNET Solutions, Inc., a Siemens Healthineers company, is upgrading its network of cyclotron-equipped radiopharmacies for PET radiopharmaceuticals with new production facilities. PET imaging with fludeoxyglucose F 18 (FDG) has gained increasing application as a highly valuable diagnostic and staging tool since it was initially approved for clinical use in oncology. Nearby production of the FDG biomarker is essential because of its short half-life of 110 minutes. As the trusted partner in PET imaging since 1996, PETNET’s radiopharmacy capabilities will also serve the growing portfolio of novel radiopharmaceuticals beyond FDG that are continually being developed to target additional disease states.
“PETNET’s expansion is really fueled by our goal for access of these very important PET tracers to more people.”
“PETNET’s expansion is really fueled by our goal for access of these very important PET tracers to more people,” explains Barry Scott, CEO of PETNET Solutions. “The PET industry has grown tremendously over the last several years and we see no signs of it slowing down. We see only acceleration of not only the volume of PET biomarkers, but the number of different ones that are going to be developed in the near future.”
Expanding access through production capability
With plans to upgrade several radiopharmacies in the coming years, PETNET selected South Florida and the Chicago, Illinois, areas in the United States to be the locations of the first two new sites. Both pharmacies will begin tracer production in 2022. Upgrades are in store not only for the sites themselves, but also for much of the tracer production equipment, such as high-capacity cyclotrons and chemical synthesis equipment.
In addition to modernized lab space and increased production capacity, the South Florida location will also operate with a 30 percent increase in staffing to meet the market demands.
“In our new South Florida facility, we’re installing two high-capacity cyclotrons,” explains Josh Nutting, PETNET’s Chief Operating Officer, “so we’ll be able to offer other tracer products in parallel to FDG. It’s really about access. We serve a lot of patients in Florida, and if we plan to enable more production capacity, that decision impacts things like an imaging center’s decision to add another scanner, and subsequently a patient’s ability to have more scheduling options for their scan. With the additional cyclotron capacity, FDG can be manufactured all day long, to meet the needs of our customers and ultimately give patients more flexibility in scheduling.”
It is a considerable financial investment to build a new radiopharmacy or upgrade an existing one with high-powered equipment and additional staff, but PETNET is being proactive about its future and the future of the industry.
“Opening a new facility in Chicago is an opportunity for us to modernize our operation from top to bottom. With a brand-new building and a highcapacity cyclotron that is replacing an older model,” says Nutting, “we’re able to significantly improve our capacity for today and into the future. We serve a lot of patients in the area and there’s a fair amount of tracer development in the area as well.”
“We’re on track with a plan to put a lot of investment back into our network to make sure we can handle capacity for years to come,” explains Scott. “Today we can reach about 98% of the US population with our pharmacies. To make sure we’ve got horsepower for five years from now, we’ve got to start investing now. It takes a lot of time, financial commitment, and very specialized resources to open new or upgraded facilities. There’s a lengthy regulatory approval process between radiation safety, the Food and Drug Administration (FDA), and the Boards of Pharmacy. With the potential for many new tracers on the horizon, we want to make sure we stay well ahead of the wave, to where we can handle capacity and can always support access for more patients.”
PETNET’s new and upgraded facilities are not only able to offer quality, consistent tracers, but also the assurance that comes from knowing that everything that went into making that product has the high level of quality built into it.
“If you think about it,” Nutting suggests, “there is an immunocompromised patient traveling to be injected with a sterile product that has been shipped right from a PETNET facility to an imaging facility. This requires confidence in the safety and quality of that product. Bringing that level of confidence to the patient as well as the caregiver is very important for us.”
PETNET’s investment into newer, state-of-the-art facilities in its network includes additional locations in the United States and expanding PETNET’s pharmacies in Europe, specifically the United Kingdom and France. Nutting will be onsite in the UK to oversee the development, regulatory inspections, and opening of the new PETNET radiopharmacy there. When it’s operational, the pharmacy will be able to service the entire country with imaging biomarkers.
New PET tracers take personalized medicine to the next level
“FDG is wonderful for general imaging and does well in many areas, but when clinicians are looking for a very specific answer, it may not be quite as good in some cases. New biomarkers have had success in offering perspective on very specific disease cases within the body. Prostate cancer is one example,” notes Scott. “Neurology is another. Imaging plaque in the brain can be very subtle and there are new tracers that offer clinicians more clarity than they can get using CT and MRI. As we get more precise with medicine, more diagnostic agents are being developed that can image disease with much more accuracy. That’s why it’s so important. That’s what is really initiating the surge in growth we’re anticipating.”
“With the additional cyclotron capacity, FDG can be manufactured all day long, to meet the needs of our customers and ultimately give patients more flexibility in scheduling.”
As developers find successful new agents, they turn to PETNET as a partner and expert resource in commercial tracer production and to take advantage of PETNET’s expansive tracer distribution footprint, as well as bringing new tracers in the market with a deeply experienced customer-facing team. “For PETNET,” Scott emphasizes, “our vision is to be the provider and contract manufacturer of choice in PET radiopharmaceuticals because we believe in supporting the continued growth in PET/CT imaging with FDG and expanding the availability of novel PET imaging agents. We want to ensure new imaging agents are available to our customers, and ultimately for the benefit of more patients.”
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Fludeoxyglucose F 18
Brief summary and complete prescribing information for Fludeoxyglucose F 18 5-10mCi as an IV injection