Itm Isotopen Technologien Munchen Ag

Itm Isotope Technologies Munich Se

Jussi Jernström

Konstantin Zhernosekov

Mark Harfensteller

Marian Meckel

Yury Totskiy

Nevzat Kelmendi

Mark Dr-Ing Harfensteller

A method for the manufacture of highly purifiedGe material for radiopharmaceutical purposes. The invention particularly concerns the production ofGe-API (API=Active Pharmaceutical Ingredient) solution complying with the Guidelines for good manufacturing practices (GMP). Starting material for the method of the present invention can be aGe stock solution of commercial or other origin as raw material. SuchGe containing raw solutions are purified from potential metal and organic impurities originating from production processes. The radiochemical method disclosed is based on a twofold separation ofGe from organic and metallic impurities with two different adsorbent materials. During the first separation phaseGe is purified from both organic and metallic impurities by adsorption in germanium tetrachloride form, after which hydrolyzedGe is purified from remaining metallic impurities by cation exchange. The finalGe-API-product e.g. fulfills the regulatory requirements for specifications of the GMP production ofGe/Ga generators.

Method for the manufacture of highly purified 68Ge material for radiopharmaceutical purposes

AGe/Ga generator for a continuous production of aGa daughter nuclide, wherein theGe parent nuclide thereof is specifically adsorbed to an inorganic support material and wherein saidGe parent nuclide continuously decays toGa by electron capture at a half-life of 270.82 d, wherein the inorganic support material is at least one oxide of a metal being selected from the group consisting of: Vanadium, Niobium and Tantalum. The use of at least one oxide of a metal being selected from the group consisting of: Vanadium, Niobium and Tantalum as an inorganic support material for the manufacture of aGe/Ga generator for pharmaceutical purposes. With the inorganic support material of the present invention, it is possible to loadGe/Ga generators with up to 8000 MBq ofGe (corresponding to 80 &#x3bc;g Germanium).

68Ge/68Ga generator

Growing community of inventors

Neufahrn, Germany

Jussi Jernström