Feature | August 27, 2012

Manhattan Isotope Starts Formal Process to Produce Sr-82

 Positron radioisotopes low-res

August 27, 2012 — Positron Corp., a molecular imaging healthcare company, announced the submission of a drug master file (DMF) with the U.S. Food and Drug Administration (FDA) for the production of active pharmaceutical ingredient (API)-grade strontium-82 (Sr-82) through its wholly owned subsidiary, Manhattan Isotope Technology LLC (MIT). This will offer a second source for the nuclear myocardial perfusion cardiac imaging agent.

A DMF is a document submitted to the FDA that contains complete information on an API or finished drug dosage form. The DMF contains factual and complete information on a drug product's chemistry, manufacturer, stability, purity, impurity profile, packaging and the cGMP status of any human drug product. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.

Manhattan Isotope’s DMF submission initiates the protocol, procedures and compliance required to produce Sr-82 for radiopharmaceutical applications, specifically for commercial use in Sr-82/Rubidium (Rb)-82 generators. Sr-82/Rb-82 generator manufacturers may now qualify MIT as a supply source and vendor for API grade Sr-82. 

Manhattan Isotope’s DMF positions the company as the only commercial entity in the United States in the Sr-82 processing and production arena. Currently, the U.S. Department of Energy (DOE) is the only domestic supplier for many of the more than 300 different isotopes, which are critical in medical, commercial, research and national security applications. Recent shortages have emphasized the importance of managing the demand for critical isotopes.

“Our submission of the DMF is a very significant milestone, as it signifies Positron’s evolution towards a vertically integrated nuclear medicine healthcare company," said Jason Kitten, president of MIT. "Positron, through MIT, is the first private entity to demonstrate the expertise and ability to enter the market as a processor and supplier of API-grade strontium-82. Proficiencies in this segment are key to our end-to-end solution strategy. Positron’s ability to supply strontium and support production needs will not only stabilize the source supply of strontium-82, but will also lend growth to and strengthen the cardiac positron emission tomography (PET) market as a whole.”

For more information: www.positron.com

Related Content

Colored areas of the brain represent regions where the loss of brain synapses in people with early-stage Alzheimer’s was greater than people with normal cognitive function.

Colored areas of the brain represent regions where the loss of brain synapses in people with early-stage Alzheimer’s was greater than people with normal cognitive function. Image courtesy of YaleNews.

News | PET Imaging | May 14, 2020
May 14, 2020 — New imaging technology allows scientists to see the widespread loss of brain synapses in early stages
The Society of Nuclear Medicine and Molecular Imaging's 2020 annual meeting has been reimagined, and is now the SNMMI 2020 Annual Meeting — Virtual Edition
News | Coronavirus (COVID-19) | April 30, 2020
April 30, 2020 — The Society of Nuclear Medicine and Molecular Imaging's 2020 annual meeting has been reimagined, and
 Siemens Healthineers has received clearance from the Food and Drug Administration (FDA) for its AIDAN artificial intelligence technologies on the Biograph family of positron emission tomography/computed tomography (PET/CT) systems

 Siemens Healthineers received clearance from the FDA for its AIDAN artificial intelligence technologies on the Biograph family of positron emission tomography/computed tomography (PET/CT) systems.

News | Artificial Intelligence | April 22, 2020
April 22, 2020 — Siemens Healthineers has received
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2 U.S. Army Spc. Jonathon Hyde and Spc. Casymn Harrison from the 1434th Engineer Company, Grayling, Mich., Michigan National Guard, prepare patient rooms at TCF Regional Care Center in Detroit in advance of receiving COVID-19 patients, April 9, 2020 #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2

U.S. Army Spc. Jonathon Hyde and Spc. Casymn Harrison from the 1434th Engineer Company, Grayling, Mich., Michigan National Guard, prepare patient rooms at TCF Regional Care Center in Detroit in advance of receiving COVID-19 patients, April 9, 2020. The TCF Center in Detroit has been converted into a 970-bed alternative care facility for COVID-19 patients by the Federal Emergency Management Agency, in partnership with the U.S. Army Corps of Engineers and Michigan National Guard. (Photo courtesy of U.S. Air National Guard photo by Master Sgt. Scott Thompson)

Feature | Coronavirus (COVID-19) | April 15, 2020 | By Melinda Taschetta-Millane and Dave Fornell
In an effort to keep the imaging field updated on the latest information being released on coronavirus (COVID-19), th
Maximum-intensity PET projections at each time point for one rhesus monkey in the 89Zr-DFO-squaramide-anti-gD group.

Maximum-intensity PET projections at each time point for one rhesus monkey in the 89Zr-DFO-squaramide-anti-gD group. Image courtesy of Eric Berg, University of California, Davis, CA

News | PET Imaging | April 10, 2020
April 10, 2020 — Combining 89Zr-labeled antibodies with total-body...
Recommended best practices for nuclear imaging departments under the COVIF-19 pandemic have been issues by the ASNC and SNMMI. #COVID19 #ASNC #SNMMI #Coronavirus #SARScov2
News | Coronavirus (COVID-19) | April 03, 2020
April 3, 2020 — A new guidance document on best practices to maintain safety and minimize contamination in nuclear im