Feature | August 27, 2012

Manhattan Isotope Starts Formal Process to Produce Sr-82

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

GE Healthcare, Rapiscan stress imaging agent, North America, Rapidscan Pharma Solutions Inc.
News | Pharmaceuticals| February 07, 2017
GE Healthcare’s Life Sciences business announced in January that it acquired Rapidscan Pharma Solutions Inc., which has...
IBA Molecular, acquisition, Mallinckrodt Nuclear Imaging, nuclear imaging
News | Nuclear Imaging| January 30, 2017
IBA Molecular has successfully completed its acquisition of Mallinckrodt Nuclear Imaging, announced in August 2016,...
stress, brain activity, cardiovascular risk, PET-CT, MGH, ISSMS, The Lancet study
News | Cardiac Diagnostics| January 18, 2017
A study led by Massachusetts General Hospital (MGH) and Icahn School of Medicine at Mount Sinai (ISSMS) investigators...
News | Radiopharmaceuticals and Tracers| January 17, 2017
NorthStar Medical Technologies LLC has received additional matching funds from the U.S. Department of Energy’s National...
Medrad Intego PET Infusion System, recall
News | Nuclear Imaging| January 12, 2017
January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Admini
Nuclear cardiology, dose reduction, myocardial perfusion imaging
News | Nuclear Imaging| January 05, 2017
January 5, 2017 — Working in concert, the American Society of Nuclear Cardiology (ASNC), the Intersocietal Accreditat
SNMMI Develops USP Recommendations for Compounded Sterile Radiopharmaceuticals
News | Radiopharmaceuticals and Tracers| December 28, 2016
December 28, 2016 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has developed United States Pharmac
PET, F-18 florbetaben, cardiac amyloidosis, Princess Alexandria Hospital

In a pilot study, F-18-florbetaben PET imaging appeared promising for differentiating between cardiac amyloidosis and hypertensive heart disease. Image courtesy of W. Phillip Law/Princess Alexandra Hospital, Brisbane, Australia.

News | Nuclear Imaging| December 06, 2016
Researchers at Princess Alexandra Hospital, Brisbane, Australia, have demonstrated that cardiac amyloidosis (abnormal...
PET/CT, calcium blockages, heart attack risk, Intermountain study, American Heart Association, AHA Scientific Sessions 2016
News | PET-CT| November 15, 2016
Many people who experience chest pain but don’t have a heart attack breathe a big sigh of relief when a stress test...
PET/CT, atherosclerotic plaque detection, Stanford University

Application of dual-modality optical and PET/CT activity-based probe in experimental carotid inflammation model. Coronal noninvasive PET/CT scans of (A) healthy and (B) diseased mice with and without ligated carotid arteries respectively. Inset images show optical ex vivo florescence imagining of (A) healthy and (B) diseased carotid arteries.  PET/CT and optical images courtesy of Xiaowei Ma, Toshinobu Saito and Nimali Withana.

News | PET-CT| November 01, 2016
Researchers at Stanford University have demonstrated for the first time the use of a dual optical and positron emission...
Overlay Init