Advanced Medical Isotope Corporation (AMIC) has begun the production and distribution of medical isotopes within the United States, and hopes to disseminate the process throughout the country by expanding its production facilities domestically and globally with purchases and strategic relationships.
AMIC began discussing the medical isotope developmental process in May 2006, when the company was established. However, “the Chalk River incident just happened to coincide very neatly with our decision to begin a domestic supply of medical isotopes,” Marishka Pilsch, the director of marketing at AMIC, told Health Imaging News.
In November 2007, the Atomic Energy of Canada Ltd. (AECL) ordered a maintenance shutdown of MDS Nordion of Chalk River, Ontario, which caused a massive disruption in supplies to about two-thirds of the global medical isotopes market. Though the reactor stopped production for only one month, the global supply was drastically affected because it produced 50 to 80 percent of the world’s supply of molybdenum-99, the isotope that breaks down into technetium-99. Last month, the AECL decided to stop the development of two isotope-producing reactors at Chalk River due to a lack of funding.
More than 15 million nuclear medicine procedures are currently performed each year in the United States. Approximately one-third of all patients admitted to U.S. hospitals undergo at least one medical procedure that employs the use of medical isotopes—evidence a domestic supply is needed, according to AMIC.
“AMIC has the promise to be the major U.S. supplier of medical isotopes with application for major diseases,” Robert E. Schenter, MD, chief science officer at AMIC, told Health Imaging News.
“In the last two years, we have been building production facilities all across the country. Today, we have begun the production of medical isotopes both on the West Coast and the East Coast, as well as burgeoning connections to various U.S. universities,” he added.
In fact, AMIC installed a compact linear accelerator designed specifically for the production of medical isotopes at its Kennewick, Wash.-based facility in March.
At the time, AMIC CEO William J. Stokes said: “With this compact linear accelerator, the first of its kind in North America designed specifically for the production of PET isotopes such as Fluorine-18, Nitrogen-13, Carbon-11, and Oxygen-15, our team will also be able to produce other highly desired, longer lived isotopes including actinium-225, iodine-123 and indium-111 for diagnostic as well as therapeutic applications.”
Late last month, after receiving its radioactive materials license from Washington state, AMIC successfully produced fluorine-18, its first in a series of isotopes that company began manufacturing at its Kennewick facility.
“We are now able to ship fluorine-FDG. We not only make the fluorine-18, but we add the compound that makes it a radiopharmaceutical that can be injected into the patient,” Schenter said.
“As we make radiopharmaceuticals, we will also require FDA approval, but we certainly made a giant stride by getting authority from the state of Washington to allow us to supply our local hospital with fluorine-FDG,” he added.
The license “allows AMIC to proceed with startup operations of our showcase production center, which is built around the nation's first compact proton linear accelerator used for isotope production,” Stokes said.
“We plan to begin shipping of this PET isotope all around the state of Washington soon, which is just the tip of the iceberg. Then we will be making additional isotopes with the same machine, such as iodine-123—an extremely important diagnostic isotope—that can be shipped 300 to 400 miles. We are also making indium-111 in Buffalo, N.Y.,” he said.
The company also hopes to expand its production abilities across the United States. According to Schenter, the company currently has working/strategic relationship with several universities, such as Lawrence Berkeley National Laboratory in Berkeley, Calif., Idaho State University in Pocatello, Idaho, and the University of Missouri in Columbia, Miss.
However, the company is also in discussion with future AMIC PET production centers in Los Angeles and Oahu, Hawaii, according to Schenter.
“Now that the Canadians have announced that they are closing