February 28, 2013 - Lawson and Partners Awarded $7 Million for Production of Non-Reactor Based Isotopes

February 28, 2013 - Lawson and Partners Awarded $7 Million for Production of Non-Reactor Based Isotopes
Natural Resources Canada has awarded Dr. Michael Kovacs and Lawson Health Research Institute $1.2 million over 4 years to achieve large scale production, distribution, supply and commercialization of Technetium-99m


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LONDON, ONLawson Health Research Institute (Lawson) and three partner organizations have been awarded $7 million to support production of non-reactor based medical imaging isotopes.  The project is funded by Natural Resources Canada (NRCan) through the Isotope Technology Acceleration Program (ITAP).

Technetium-99m (Tc-99m) is the world’s most widely-used medical isotope and is essential to 5,500 diagnostic medical scans done daily in Canada. The bulk of the worldwide supply is produced by small number of nuclear reactors, including Canada’s Chalk River, which is scheduled for decommissioning in 2016. Alternative sources of medical isotopes are needed to meet global demands.

Lawson (London, ON), the Centre for Probe Development & Commercialization (Hamilton, ON), the BC Cancer Agency and TRIUMF (Vancouver, BC) have teamed up in an effort to meet this need. Over the last three years, the group has demonstrated that medical cyclotrons are a potential alternative for producing Tc-99m.

Now, over the next three years, the goal is to ramp up full-scale production levels using medical cyclotrons already operational in Ontario and British Columbia. The project will validate production and quality control methods, conduct a clinical trial, pursue Health Canada approvals, and develop supply chains to move toward commercialization of this technology. 

“We are very proud to be continuing our collaborative research with our partners,” said Dr. Michael Kovacs, Director of the Lawson Cyclotron & PET Radiochemistry Facility located at St. Joseph’s Health Care London's St. Joseph's Hospital.  “With our state-of-the-art cyclotron and radiochemistry equipment, Lawson will be a key part of providing a reliable supply of Tc-99m for patients in London and region and across the country.”

 

SPECT/CT bone scan using Tc-99m-MDP: Scan shows the Tc-99m uptake in a benign bone tumour in a coronal slice of the human pelvisSPECT/CT bone scan using Tc-99m-MDP: Scan shows the Tc-99m uptake in a benign bone tumour in a coronal slice of the human pelvis

MDP:  methylene diphosphonate
SPECT:  Single Photon Emission Computed Tomography
CT:  Computed Tomography

 

PROJECT DESCRIPTION

Technetium-99m (Tc-99m) is the world's most highly used medical isotope and is the critical component in more than 76,000 imaging procedures per day. Historically, Tc-99m has been produced in a select number of nuclear reactors around the world, including Canada's Chalk River Reactor. These reactors produce large quantities of molybdenum-99  (Mo-99) which undergoes radioactive decay to form Tc-99m within special generators as they are shipped and stored at local hospitals.

With many of the world's Tc-99m producing nuclear reactors aging, including Chalk River (scheduled to shut down in 2016), work is under way to demonstrate the production of Tc-99m using particle acclerators, such as the Lawson medical cyclotron located at St. Joseph's Healthcare, London.

Cyclotrons dedicated to producing medical isotopes other than Tc-99m aleady exist in a number of hospitals across the country. This project brings together four of these facilities to demonstrate what it takes to produce Tc-99m directly.  Depending on the machine capability, a large metropolitan area could be supplied by a single dedicated, or a handful of partially dedicated, medical cyclotrons. By enabling regional hospitals to produce and distribute this lifesaving isotope to local clinics, widespread supply disruptions will be an issue of the past.  

Natural Resources Canada (NRCan), via its ITAP initiative, is supporting the implementation of key procedures, cyclotron modifications and large-scale isotope production protocols. Once complete, these paramaters will be standardized in order to allow existing cyclotron sites to produce Tc-99m in any given area. The team will also establish the logistics associated with clinical sites that serve small, medium, and large patient populations.   

The approach that Lawson and its partners are pursuing will ensure that the arising technology can be quickly implemented in many regions of the country, thereby supporting Canada’s universal and accessible approach to healthcare. It will also create new opportunities to export Canadian technology to international partners and across multiple business sectors thus maintaining Canada as an international leader in an emerging health technology market.

By the completion of the NRCan-ITAP project, the team expects to be capable of producing Tc-99m on three different brands of medical cyclotrons at a commercial scale. Production and distribution of this most commonly used isotope from a regional supply hub will de-centralize the process, helping Canada to avoid future isotope shortages. Canada’s medical and accelerator communities will benefit through the development and testing of high-powered, novel isotope separation, and purification methods. In addition, with medical cyclotrons producing Tc-99m, there would be no radioactive waste disposal issues.

This effort has seen Canada’s nuclear medicine community come together to develop a new radiopharmaceutical and can serve as a basis for future work toward other medically-relevant radioisotopes.

No single institution could tackle a program of this nature. The required expertise is too broad. To overcome this, our project brings together experts from across Canada with specialties in:

  • Isotope production;
  • Cyclotron science and engineering;
  • Radiopharmaceutical manufacturing;
  • Quality assurance and control;
  • Regulatory affairs; and
  • Commercialization.

THE ROLE OF LAWSON

Lawson will receive over $1.2 million for the ITAP project.  Our goals are to (i) develop a method for producing Technetium-99m on its self-shielded medical cyclotron in sufficient commercial quantities to supply London, Ontario and the surrounding area, and (ii) commercialize the resulting intellectual property.

Steps will include:

  • Assisting in the development and field testing of a robust system of hardware used to automatically transfer, irradiate and process Mo-100 targets.
  • Irradiating the Mo-100 targets with 16.5MeV protons from the cyclotron to produce Tc-99m
  • Transferring the Tc-99m to a hot cell for further processing
  • Automating dissolution and purification of the Tc-99m
  • Developing of new QC protocols unique to cyclotron-produced Tc-99m
  • Satisfying GMP requirements necessary for Health Canada approval of cyclotron-produced Tc-99m pertechnetate
  • Securing Health Canada approval of the cyclotron-produced Tc-99mm, including conducting a clinical trial
  • Pursuing and evaluating various options for capturing the commercialization potential of the resulting technology

There are several challenges that must be overcome prior to successfully executing this project including:

  • Collaborating with TRIUMF to field test the target station and targets themselves that will hold the Mo-100
  • Working with with General Electric Healthcare to increase the cyclotron beam output by as much as 60%
  • Identifying the profile of impurities unique to Tc-99m made at 16.5MeV proton energy and establishing acceptable safety limits with Health Canada

 

Lawson Health Research Institute, located in London, Ontario, is one of Canada’s  largest and most respected hospital-based research institutes.  As the research arm of London Health Sciences Centre and St. Joseph’s Health Care, London, and working in partnership with The University of Western Ontario, Lawson is committed to furthering scientific knowledge to advance health care around the world. Its state-of-the-art, 6,000 sq. ft. Cyclotron & Radiochemistry Facility opened on March 31, 2010 and includes a GE PETtrace 880 cyclotron with proton and deuteron acceleration capability, class 100 shielded hot cells, and automated chemistry units for producing F-18 and C-11 radiopharmaceuticals – all to GMP specifications.

Lawson Imaging is considered one of the top integrated medical imaging programs in Canada. Its approach embraces all major imaging modalities, including PET, SPECT, CT, MRI, MRS, Optical, Ultrasound, Near-Infrared Spectroscopy, and Photoacoustics, and the hybrid imaging platforms of PET/CT, SPECT/CT and PET/EEG/MR. Lawson's Cyclotron & PET Radiochemistry Facility, established in February 2010, allows for the on-site production of Positron Emitting Radiopharmaceuticals for PET imaging. In addition, Lawson received the first PET/MR scanner in Canada on February 7, 2012.  World-class research led by a team of 30 Scientists focuses on imaging technology development and applications in cardiology, oncology, neurology (including mental health) and metabolic diseases. External funding over the last five years has topped $45 million. The program also serves as a hospital-based centre for the training of approximately 75 graduate and undergraduate students, post-doctoral fellows, medical residents and technologists each year in the field of medical imaging.

 

For More Information:

 

James Bullbrook
Manager, Communications & External Relations
Lawson Health Research Institute
519-646-6000 ext. 75677
james.bullbrook@lawsonresearch.com

 

Steven Foster
Business Manager, Lawson Imaging
Lawson Health Research Institute
519-646-6000 ext. 64648
steven.foster@lawsonresearch.com

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