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Biotechnology News Magazine

Isotopia Molecular Imaging and Seibersdorf Labor GmbH Announce Production Agreement for 177Lu n.c.a.

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

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Seibersdorf Labor, a GMP Contract manufacturing of radiopharmaceuticals, a global leader in the development, production and commercialization of radiopharmaceuticals, will produce 177Lu n.c.a in collaboration with Isotopia Molecular Imaging for distribution in Europe.

Isotopia has selected Seibersdorf, located in Austria, following a year-long evaluation process that included the review several proposals from sites across Europe. It was selected due to the high level of expertise on site, the GMP infrastructure and the team’s enthusiasm to manufacture lifesaving radiopharmaceuticals. In addition, the location provides easy and safe land transportation access to the European market.

The production facility is expected to be ready by Q4 2022.

177Lu n.c.a 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. 177Lu n.c.a 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: This step supports Isotopia’s global strategy to simplify and shorten the supply route to our customers. We are working intensively to complete our plan to establish a production site in each continent. This, to provide a total solution to pharma companies and hospitals together with labeling services. The production and labeling facility in Seibersdorf Laboratories will be the best solution for Europe, enabling Isotopia to deliver a reliable, flexible, and most important, secure land supply of a broad range of critical medical isotopes to European customers, starting with Lu177 n.c.a. We have found in Seibersdorf the best partner sharing the same vision to save lives”.

Seibersdorf’s CEO, Martina Schwaiger stated: “The new production agreement is an exciting opportunity for our organization and we are pleased to be working with Isotopia Molecular Imaging on this important sector of medical care.”

Isotopia and Seibersdorf intend to expand their partnership to include commercial-scale production of 177Lu n.c.a and labeling services to meet future commercial market demand. In addition, both companies have also committed to collaborate on the development of GMP manufacturing processes for other emerging medical isotopes.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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