PROCESS FOR THE MANUFACTURE OF VIRUS SAFE IMMUNOGLOBULIN
    1.
    发明公开
    PROCESS FOR THE MANUFACTURE OF VIRUS SAFE IMMUNOGLOBULIN 审中-公开
    方法生产病毒免疫球蛋白安全

    公开(公告)号:EP1709077A1

    公开(公告)日:2006-10-11

    申请号:EP05708144.0

    申请日:2005-01-31

    发明人: PARKKINEN, Jaakko

    IPC分类号: C07K16/06 A61K39/395

    摘要: Process for preparing a purified immunoglobulin preparation. The process comprises the steps of subjecting a crude immunoglobulin solution to caprylic acid treatment, removing protein aggregates and viruses from the immunoglobulin solution, subjecting the immunoglobulin solution to anion exchange chromatography in order to purify the immunoglobulin, filtering the immunoglobulin solution thus obtained on a virus-removal filter to produce an eluate containing immunoglobulin, and recovering the immunoglobulin. By combining caprylic acid treatment and precipitation with a protein precipitant the level of aggregated proteins and viruses is effectively reduced and a truly virus safe preparation is provided after filtration.

    METHOD FOR PREPARING VIRUS-SAFE PHARMACEUTICAL COMPOSITIONS
    3.
    发明公开
    METHOD FOR PREPARING VIRUS-SAFE PHARMACEUTICAL COMPOSITIONS 审中-公开
    方法生产病毒安全干扰素制剂

    公开(公告)号:EP1086120A1

    公开(公告)日:2001-03-28

    申请号:EP99931279.6

    申请日:1999-06-09

    IPC分类号: C07K1/34 C07K14/56 A61K38/21

    摘要: The present invention concerns a method of preparing pharmaceutical compositions of a biologically active proteins, in particular multicomponent interferon compositions. The invention comprises the steps of adding to a solution of the protein a non-ionic detergent in an efficient amount to provide an extended shelf-life of the pharmaceutical composition; subjecting the solution containing the non-ionic detergent to filtration on a virus removal filter with a pore size of 10 to 40 nm; and recovering the filtrate. The method gives rise to, e.g., a virus-safe multicomponent α-interferon composition, comprising a non-ionic detergent as a stabilizer in an amount exceeding the critical micellar concentration of the detergent and being essentially free from substances retained on a virus-filter having high virus retentive capacity.

    PROCESS FOR MANUFACTURING OF A PHARMACEUTICAL COMPOSITION COMPRISING HUMAN APOTRANSFERRIN
    5.
    发明授权
    PROCESS FOR MANUFACTURING OF A PHARMACEUTICAL COMPOSITION COMPRISING HUMAN APOTRANSFERRIN 有权
    制造工艺药物制剂中人的非金属apotransferrin CONTAIN

    公开(公告)号:EP1094835B1

    公开(公告)日:2006-09-13

    申请号:EP99934743.8

    申请日:1999-07-06

    IPC分类号: A61K38/40 C07K14/79 C07K1/18

    摘要: The present invention relates to pharmaceutical compositions of transferrin and to the manufacture of such preparations. The present invention concerns specifically a pharmaceutical composition of apotransferrin, the iron-free form of transferrin, wherein the composition has at least 90 % of the theoretical iron binding capacity of iron-free transferrin, contains less than 3 % transferrin dimers and no detectable transferrin polymers or aggregates, and has an iron-saturation of less than 5 %. The pharmaceutical apotransferrin composition of this invention effectively binds non-transferrin-bound-iron to a harmless form when administered as an intravenous injection or infusion to patients. The pharmaceutical composition of this invention does not contain viruses, denatured forms of transferrin or other harmful components.

    PHARMACEUTICAL COMPOSITION COMPRISING HUMAN APOTRANSFERRIN AND PROCESS FOR MANUFACTURING OF THE COMPOSITION
    6.
    发明公开
    PHARMACEUTICAL COMPOSITION COMPRISING HUMAN APOTRANSFERRIN AND PROCESS FOR MANUFACTURING OF THE COMPOSITION 有权
    制造工艺药物制剂中人的非金属apotransferrin CONTAIN

    公开(公告)号:EP1094835A1

    公开(公告)日:2001-05-02

    申请号:EP99934743.8

    申请日:1999-07-06

    IPC分类号: A61K38/40 C07K14/79 C07K1/18

    摘要: The present invention relates to pharmaceutical compositions of transferrin and to the manufacture of such preparations. The present invention concerns specifically a pharmaceutical composition of apotransferrin, the iron-free form of transferrin, wherein the composition has at least 90 % of the theoretical iron binding capacity of iron-free transferrin, contains less than 3 % transferrin dimers and no detectable transferrin polymers or aggregates, and has an iron-saturation of less than 5 %. The pharmaceutical apotransferrin composition of this invention effectively binds non-transferrin-bound-iron to a harmless form when administered as an intravenous injection or infusion to patients. The pharmaceutical composition of this invention does not contain viruses, denatured forms of transferrin or other harmful components.

    TREATMENT OF PLASMA
    7.
    发明公开
    TREATMENT OF PLASMA 失效
    治疗血浆

    公开(公告)号:EP0762893A1

    公开(公告)日:1997-03-19

    申请号:EP95920114.0

    申请日:1995-05-31

    发明人: PARKKINEN, Jaakko

    IPC分类号: A61L2

    摘要: The invention relates to a method for the treatment of a blood plasma preparation in order to inactivate possible viruses in the preparation. In the method, ascorbate and photoactive substance such as phenothiazine dye are added to the preparation, and the preparation is irradiated at a wavelength which excites the photoactive substance.