Isotopia, CPDC Announce Production Agreement for n.c.a. Lu-177

By News Release

Isotopia Molecular Imaging and CPDC are pleased to announce that they have entered into an agreement for the production and distribution of no-carrier-added Lutetium-177 (n.c.a. Lu-177), a critical medical radioisotope used in the manufacturing of radiopharmaceuticals for treatment of many types of cancer, including neuroendocrine tumors and prostate cancer.

The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, will produce n.c.a. Lu-177 in collaboration with Isotopia Molecular Imaging for distribution in North America.

n.c.a. Lu-177 is used in Targeted Radionuclide Therapy in the field of Precision Oncology. By binding n.c.a. Lu-177 isotopes to tumor-specific targeting molecules, the resulting radiopharmaceutical targets the tumor and delivers precise cell-killing radiation that spares normal healthy tissue. Isotopia has developed a reliable and unique GMP method to produce a highly pure form of Lu-177. n.c.a. Lu-177 contains no Mercury (Hg) and no metastable Lu-177m, therefore there is no need for cost intensive clinical waste management.

Isotopia's CEO & Co-Founder Dr. Eli Shalom stated "The CPDC manufacturing site is the first step towards Isotopia's global footprint plan to ensure efficient production of n.c.a. Lu-177 and will be added to its existing Drug Master File (DMF). CPDC's strategic location in Southern Ontario along with its professional and enthusiastic personnel, renowned expertise in logistics and just-in-time delivery will enhance distribution of Isotopia's n.c.a. Lu-177 and secure supply for our radiopharmaceutical and CMO clients in North America."

Isotopia and CPDC intend to expand their partnership to include commercial-scale production of n.c.a. Lu-177 at CPDC's subsidiary NuGeneris Specialty Pharmaceuticals Inc. to meet future commercial market demand. NuGeneris is a global commercial stage radiopharmaceutical manufacturing service provider.

"As a global leader specializing in radiopharmaceutical research, development and manufacturing, we recognize the importance of a stable and reliable supply of medical isotopes for manufacturing of life-altering therapies" said Justyna Kelly, CEO of CPDC. "We are looking forward to bringing this process to CPDC, which will facilitate access to n.c.a. Lu-177 for our clients and for our pipeline." Ms. Kelly added. "CPDC and Isotopia are aligned in a common vision and we are very excited about this partnership."

In addition to production of n.c.a. Lu-177, Isotopia and CPDC have also committed to collaborate on the development of GMP manufacturing processes for other emerging medical isotopes.

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Isotopia, CPDC Announce Production Agreement for n.c.a. Lu-177.  Appl Radiol. 

By News Release| September 09, 2020
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