PROCESSING | MANUFACTURING
Positron brings decades of practical experience in the manufacturing and production of radioisotopes. Through supply agreements and technology partnerships with global irradiators Positron currently produces API grade Sr-82, under its FDA Drug Master File (DMF), at its Lubbock, Texas facility. The FDA registered radioisotope production facility was commissioned specifically to support the Sr-82 lifecycle, from Sr-82 target processing to the support and service of expired Sr-82/Rb-82 generators and operates in accordance with cGMP, ICH-Q7 and ISO 9001:2008 certified for manufacturing radioisotopes. Positron is the leading commercial resource in the U.S. that possesses the practical experience and knowledge in all stages of Sr-82 production and generator lifecycle management. Positron and the Department of Energy (D.O.E.) are the only entities that hold a U.S. DMF registered with the FDA for producing/processing Sr-82. The addition of Sr-82 raw material manufacturing to our product portfolio will significantly enhance Positron's market position.
Currently, Positron has supply agreements and technology partnerships with global irradiators for the production of Sr-82. Beginning in 2014, Positron will introduce additional supply of Sr-82 into the marketplace, leading to an increase in the availability of Rb-82 generators and the need for PET systems. The Company’s ability to supplement the supply of key radioisotopes, complemented by award winning nuclear imaging technology and clinical services, positions Positron as the industry’s authority in the business of cardiac PET.
Rubidium-82 chloride (Rb-82) is currently marketed under the brand name Cardiogen-82. Bracco Diagnostics is the sole market provider of Rb-82 generators at this time. However, Jubilant DraxImage, a Canadian based company, is currently under active review with the FDA for commercial use of their proprietary Rb-82 generator.
Positron’s plans to ensure an indigenous and commercial source of Sr-82 will add greater stability and security to the industry, further accelerating the adoption of cardiac PET. Positron seeks to support and expand the availability of Rb-82 generators through this increase of Sr-82 supply.