Blood Plasma Product
    4.
    发明公开

    公开(公告)号:US20240131063A1

    公开(公告)日:2024-04-25

    申请号:US18467089

    申请日:2023-09-14

    IPC分类号: A61K35/16 A61K9/19

    CPC分类号: A61K35/16 A61K9/19

    摘要: The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the mean size of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment.

    Spray Drying Process That Reduces Pathogens
    5.
    发明公开

    公开(公告)号:US20240131062A1

    公开(公告)日:2024-04-25

    申请号:US18467063

    申请日:2023-09-14

    IPC分类号: A61K35/16 A61L2/00

    摘要: The spray dried plasma by the nature of its characteristics and the process by which it is made allows for a dried plasma with reduced pathogens. It has at least three aspects of pathogen reduction that results in a plasma product with reduced or no pathogens. The first aspect relates to a spray drying disposable and machine that eliminates or minimizes the introduction of pathogens into the spray drying process and is referred to as the anti-contamination process. The second aspect of pathogen reduction relates to the spray drying process and parameters that reduces pathogens that may be present in the donor plasma, and/or inhibit pathogen growth and/or pathogen proliferation introduced by the donor plasma. The third aspect results in reduced pathogens occurring during storage of the dried plasma wherein the manufacturing and storage conditions are such that pathogens are reduced, and/or pathogen growth and/or pathogen proliferation are inhibited.