Monrol signs agreement with Curium to license GMP grade production technology

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Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) recently announced that it has signed an agreement with Curium Netherlands B.V (Curium) to license its GMP grade medical radioisotope, no-carrier-added 177Lu (n.c.a. 177Lu) cutting-edge production technology ‘LuMagic’. This agreement will enable transfer of relevant equipment and supply from Monrol to Curium.

Monrol is one of the few producers of Lutetium-177 n.c.a worldwide, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability. Curium planning to manufacture the product Lu-177 n.c.a in its Petten production facility, Netherlands. This licence is offering significant opportunities both for Curium; one of the world’s largest nuclear medicine companies and Monrol; a company which develops, manufactures, and distributes world-class radiopharmaceutical products, radioisotopes to improve quality of life of cancer patients globally.

Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today and more potential treatment options in future under clinical development. Unique properties of Lutetium-177 n.c.a makes it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET) and Prostate cancer.

In line with the mission to improve the quality of life of cancer patients globally, Monrol is establishing strategic partnerships with multinational pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards which will have an annual production capacity of 60 thousand doses. With its location close to Istanbul’s transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

“Lu-177 n.c.a contributes to our mission to improve quality of life of cancer patients globally. Our new GMP certified facility exclusively designed for theranostic R&D and production with cutting edge technology will enable us to maximize supply of high-quality Lutetium. We are committed to working closely with Curium to potentially bring new therapeutic radiopharmaceutical agents into market soon to improve patients’ lives having life threatening diseases” said Monrol General Manager Aydın Kucuk”.

John Sylvester CEO of Curium’s SPECT and International businesses commented “We are delighted with Monrol as a technology partner, after extensive benchmarking this technology gave both the highest quality product with the most efficient process, as it is already proven and ‘plug and play’ in nature the time to market will be very short”.

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