High concentration immunoglobulin composition for pharmaceutical application

    公开(公告)号:US11191833B2

    公开(公告)日:2021-12-07

    申请号:US16308356

    申请日:2017-06-12

    申请人: OCTAPHARMA AG

    摘要: The present invention relates to a liquid composition comprising polyclonal immunoglobulins, at least one viscosity modulating amino acid, selected from arginine and histidine, and at least one stabilising amino acid, selected from glycine and proline, wherein more than 90% of the polyclonal immunoglobulins are in the form of monomers or dimers and less than 5% in the form of polymers, and wherein the immunoglobulin concentration in the composition is above 160 g/L and the pH is in the range from 5.2 to 5.9. The invention further relates to a liquid composition for use in medical treatment, to amino acids for formulating a highly concentrated polyclonal immunoglobulins as well as a method of formulating.

    POLYPEPTIDES MODULATING SIGLEC DEPENDENT IMMUNE RESPONSES

    公开(公告)号:US20210275644A1

    公开(公告)日:2021-09-09

    申请号:US17326709

    申请日:2021-05-21

    申请人: OCTAPHARMA AG

    摘要: The invention relates to a glycosylated polypeptide comprising an amino acid sequence being identical or homologous to at least a fragment of a mammalian, preferably a human protein, wherein said glycosylated polypeptide contains one or more sialylated O-glycans and wherein the glycosylated polypeptide shows an increased binding affinity to one or more SIGLECs, selected from SIG-5, SIG-7, SIG-8, and SIG-9 compared to the mammalian protein or fragment thereof. The invention further relates to composition comprising a first and a second polypeptide, wherein the first polypeptide is a glycosylated polypeptide containing one or more sialylated O-glycans and the second polypeptide contains an amino acid sequence homologous or identical to a second mammalian, in particular human protein, wherein compared to the second polypeptide the composition has an increased binding affinity to a SIGLEC selected from to one or more SIGLECs, selected from SIG-5, SIG-7, SIG-8, and SIG-9.

    TEST FOR HEMOLYTIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND FORMULATIONS FOR RISK MINIMIZATION
    40.
    发明申请
    TEST FOR HEMOLYTIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND FORMULATIONS FOR RISK MINIMIZATION 审中-公开
    药物产品和风险最小化配方的化学势试验

    公开(公告)号:US20150250879A1

    公开(公告)日:2015-09-10

    申请号:US14431498

    申请日:2013-09-26

    申请人: OCTAPHARMA AG

    IPC分类号: A61K47/18 C07K16/18 G01N33/49

    摘要: A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to −0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.

    摘要翻译: 一种非溶血酸性组合物,其包含选自免疫球蛋白A,免疫球蛋白G或免疫球蛋白M的免疫球蛋白,其pH值在4.65至5.7范围内,包含一种或多种选自浓度范围为100的氨基酸,糖和糖醇的赋形剂 -350mmol / l,特别是200-350mmol / l,其特征在于当在分光光度计中在414nm处测定OD时,它的光密度(OD)在0.14至-0.1的范围内,膜厚度 0.825毫米; 并且其用于测定静脉内施用的药物和组合物和制剂的溶血潜力的测定法,其在静脉内施用时显示出降低的溶血潜力。