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

    公开(公告)号:US20210198116A1

    公开(公告)日:2021-07-01

    申请号:US16077892

    申请日:2018-03-20

    摘要: A method for the manufacture of highly purified 68Ge material for radiopharmaceutical purposes. The invention particularly concerns the production of 68Ge-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 a 68Ge stock solution of commercial or other origin as raw material. Such 68Ge 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 of 68Ge from organic and metallic impurities with two different adsorbent materials. During the first separation phase 68Ge is purified from both organic and metallic impurities by adsorption in germanium tetrachloride form, after which hydrolyzed 68Ge is purified from remaining metallic impurities by cation exchange. The final 68Ge-API-product e.g. fulfills the regulatory requirements for specifications of the GMP production of 68Ge/68Ga generators.

    Methods for quantitating individual antibodies from a mixture

    公开(公告)号:US11020686B2

    公开(公告)日:2021-06-01

    申请号:US16322292

    申请日:2017-08-08

    摘要: The present disclosure relates to, inter alia, a method of quantitating an amount of an antibody molecule from a mixture comprising two or more antibody molecules, comprising separating each of the two or more antibody molecules from the mixture by hydrophobic interaction chromatography high performance liquid chromatography (HIC-HPLC) and quantitating an amount of each antibody molecule, wherein the molecular weight of each antibody molecule is within 15 kDa of any other antibody molecule in the mixture and either each antibody molecule is different from another antibody molecule in the mixture by more than about 0.25 unit on the Kyte & Doolittle hydropathy scale or each of the antibody molecules when nm alone on HIC-HPLC elutes at distinct run time with little overlap from the other antibody molecules in the mixture, or both.