McMaster, Terumo and AtomVie Global Radiopharma Inc. partner to manufacture medical devices for cancer treatment

McMaster University, Terumo and AtomVie Global Radiopharma Inc. (AtomVie) have partnered to produce two medical devices used for the treatment of cancer. Composed of radioactive holmium-166 microspheres, QuiremSpheres™ and QuiremScout™ are used in Selective Internal Radiation Therapy (SIRT) to treat liver cancer. Terumo is the legal manufacturer of both medical devices.

Last month, McMaster manufactured its first patient dose on behalf of Terumo. The microspheres were irradiated in the McMaster Nuclear Reactor and then processed and dispensed in a hot lab at the McMaster University Medical Centre. The product was shipped to a hospital in Europe and successfully used in a patient procedure.

The McMaster Nuclear Reactor will increase production capacity and expand logistics coverage for the devices, making the first patient treatment an important milestone in Terumo’s mission to drive personalized patient care in oncology to patients globally.

AtomVie is a spinout by the Centre for Probe Development and Commercialization – a McMaster-associated Centre of Excellence for Commercialization and Research (CECR) – and a world-leading Contract Development and Manufacturing Organization (CDMO) that specializes in the development, GMP manufacturing and global distribution of radiopharmaceuticals. AtomVie is collaborating with McMaster to operate and maintain a specialized cGMP-compliant dispensing laboratory designed for processing the microspheres.

Megan Blacker, Isotope Production Manager with McMaster’s Nuclear Operations & Facilities unit, says the new lab will support growing demand for the treatment around the globe.

“Holmium-166 has a half-life of 27 hours and a patient dose typically has to be administered within 48 to 72 hours of production, which makes it challenging to transport the microspheres from the reactor to the dispensing lab and finally to the patient for administration in a timely manner,” says Blacker. She notes that McMaster’s isotope production team had only five hours after the irradiated microspheres were transported to the hot lab across campus to process the microspheres, conduct stringent quality testing, dispense the prescribed patient dose and package the treatment for its flight to Europe.

“This was the first dose produced, processed and packaged entirely on the McMaster campus by our incredible isotope production team. We are excited to continue working with AtomVie and Terumo as we leverage our combined expertise to strengthen the supply chain for this medical isotope and ensure patients have access to this life-saving treatment,” says Blacker.

“AtomVie is proud to work with McMaster and Terumo to bring this innovative therapeutic product to cancer patients in need,” says Bruno Paquin, Chief Executive Officer of AtomVie.

“This is a great example of a success story between three entities that complement each other’s radiopharmaceutical expertise. AtomVie’s unique skillset in the GMP manufacturing of QuiremSpheres™, along with its proximity to McMaster’s world-class nuclear research facilities, provided Terumo with the most ideal partnership in Canada, confirming Canada’s position as a leader in the radiopharmaceutical field,” adds Paquin.

“This milestone marks an exciting next step for the production of QuiremSpheres™ and the expansion of our holmium-166 platform in Europe,” says Laurent Domas, Vice-President of Global Therapeutic Interventional Oncology Strategy at Terumo.

“We are delighted that our long-standing and excellent relationship with McMaster University has now moved into a new phase with the support of AtomVie to further the success of this treatment and begin expanding access to this therapy to patients in North America.”

Dave Tucker, McMaster’s assistant vice-president, research (nuclear) says McMaster is proud to use its expertise in medical isotope research and development to advance next-generation nuclear medicines and support global health and well-being.

“McMaster has a long history of innovation in nuclear medicine. We are proud to partner with radiopharmaceutical leaders AtomVie and Terumo to produce and transport this life-saving medical isotope to treat cancer in patients across Europe and advance health research and care in Canada and abroad,” he says.

QuiremSpheres™ and QuiremScout™ are currently approved in Europe for the treatment of liver tumors and Terumo is planning to expand its approval to other regions, making McMaster and AtomVie well-positioned to support trials in North America and potentially serve as a dose production and distribution hub for patients in Canada and the U.S. once the treatment is approved.