Petach Tikva Israel and Austria, 8th Oct 2021
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.
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 radiopharmaceuticalsIn 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.
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.
About Seibersdorf Labor GmbH
Seibersdorf Labor GmbH is an Austrian company specialized in high quality laboratory and analysis work, application-oriented research and development as well as consulting and training.
The teams of Seibersdorf Laboratories are service, know-how and technology provider and cover a broad area of scientific expertise: development, production and quality control of radiopharmaceuticals, anti-doping and forensic analysis, radiation protection, ionizing and non-ionizing radiation, radio frequency engineering and electromagnetic compatibility.
The experts of Seibersdorf Laboratories represent Austria on various international committees.
For more information visit: www.seibersdorf-laboratories.at
Roland Müller, Head Pharmaceuticals, +43 50 550 3470
Isotopia Molecular Imaging Ltd. is a collaboration between The Metrontario Group and Israel’s leading scientists in the field of radiopharmaceuticals. The Isotopia development team is a multidisciplinary team consisting of nuclear pharmacists, radiochemists, nuclear engineers and physicists.
The experienced Isotopia team, together with its nuclear pharmacy, cyclotron facility, Lu-177 production site and sterile manufacturing plant, are a well-established platform for development. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications and molecular therapy. For more information about Isotopia, please visit: www.isotopia.co.il
Isotopia Molecular Imaging Ltd.
Tel: (972)-3-9130314 , KMoshkoviz@isotopia.co.il