Cardinal’s Center for the Advancement of Molecular Imaging (CAMI) had its official opening in July. The facility has paired (dual) cyclotrons that produce radioisotopes, especially those used in positron-emission tomography (PET), from predecessor radiochemicals; a collaboration laboratory that brings Cardinal specialists together with academic and industry researchers; “guest” laboratories where researchers can conduct experiments confidentially, then move such experimental projects into clinical trials; and a Global PET Production Control Center where clients can monitor, remotely via video, production activities in other parts of the world.
John Rademacher, president of the nuclear pharmacy business of Cardinal, explains that PET imaging agents are hard to work with, let alone develop as pharmaceuticals, because they have short half-lives (that is, lose their potency and degrade into other radiochemicals) in a matter of hours or days. So, production, testing and trials need to be performed in a quick, coordinated manner. And of course, working with radioactive materials is a different level of complexity compared to most types of pharmaceuticals. CAMI “brings together the entire spectrum of capabilities that are needed to research and move new radiopharmaceuticals from bench top to FDA approval; and combines them with Cardinal’s capability to commercially manufacture, dispense and distribute the product broadly across the US,” he says.
Cardinal Health’s Nuclear Pharmacy Services business is one of the leading suppliers of PET imaging agents and related radiopharmaceuticals in North America, running a network of 36 cyclotrons and 160 radiopharmacies, 100 of which are “PET-ready” to dispense unit doses of imaging agents (which tend to be patient-specific in dosage). The latest new cyclotron was added to the network in Augusta, GA, in June. The radiopharmaceutical business is dependent on a pair of production reactors (one in Canada, one in the Netherlands) that produce medical-grade molybdenum isotopes; this material is the starting point in cyclotrons to produce the PET imaging agents. There was a worldwide shortage, until recently, of the molybdenum, but the two reactors are now back online.
Rademacher says that Cardinal manufactures, compounds or distributes over 50 radiopharmaceuticals. “There is a large number on new products that are in various stages of pre-clinical and clinical trials and today we are supporting over 20 new products that are working their way toward FDA approval or are being used as building blocks for other investigation products,” he says. CAMI is “at the center of this activity.”