Lyophilized factor IX formulations
    21.
    发明授权

    公开(公告)号:US10772942B2

    公开(公告)日:2020-09-15

    申请号:US15128951

    申请日:2015-03-24

    Abstract: The present invention provides, among other things, pre-lyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide. The present invention is directed to a pre-lyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity; (b) a buffering agent; (c) a stabilizing agent; (d) a bulking agent; and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL, and wherein each of (a)-(e) are at an amount per vial (mg/vial) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized.

    Procoagulant fusion compound
    23.
    发明授权

    公开(公告)号:US10584147B2

    公开(公告)日:2020-03-10

    申请号:US15035145

    申请日:2014-11-07

    Inventor: Karina Thorn

    Abstract: The present invention provides a fusion compound comprising a procoagulant compound and an immunoglobulin constant region or a portion thereof and methods of making and using the fusion compound. The fusion compounds of the present disclosure are useful for the treatment of coagulation disorders, such as hemophilia. In some aspects, the invention includes a method of reducing or preventing aggregates which comprise a procoagulant compound comprising fusing the procoagulant compound to an immunoglobulin constant region or a portion thereof wherein the procoagulant compound comprises an amino acid sequence. In another embodiment, the fusion compound forms less aggregates compared to a compound consisting of the procoagulant compound.

    Factor VIII complex with XTEN and von Willebrand Factor protein, and uses thereof

    公开(公告)号:US10138291B2

    公开(公告)日:2018-11-27

    申请号:US14413765

    申请日:2013-07-10

    Abstract: The present invention provides a chimeric protein comprising a VWF protein comprising the D′ domain and D3 domain of VWF, one or more XTEN sequence, and a FVIII protein, wherein the VWF fragment, the XTEN sequence, or the FVIII protein are linked to or associated with each other. The chimeric protein can further comprise one or more Ig constant region or a portion thereof (e.g., an Fc region). A polypeptide chain comprising a VWF fragment of the invention binds to or is associated with a polypeptide chain comprising a FVIII protein linked to an XTEN sequence and the polypeptide chain comprising the VWF fragment can prevent or inhibit binding of endogenous VWF to the FVIII protein linked to the XTEN sequence. By preventing or inhibiting binding of endogenous VWF to the FVIII protein, which is a half-life limiting factor for FVIII, the VWF fragment can induce extension of half-life of the chimeric protein comprising a FVIII protein. The invention also includes nucleotides, vectors, host cells, methods of using the VWF fragment, or the chimeric proteins.

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