FIBRINOGEN COMPOSITIONS AND METHODS OF PREPARATION

    公开(公告)号:US20240342253A1

    公开(公告)日:2024-10-17

    申请号:US18681561

    申请日:2022-08-12

    申请人: Biotest AG

    摘要: The present invention relates to the field of blood products, in particular, to fibrinogen and fibrinogen drug products. The invention provides a fibrinogen drug product in dry, e.g., lyophilized form having a residual moisture content of 2-5% (w/w). The inventors have found that said moisture content is advantageous for viral inactivation by dry heat, which leads to a particularly virus-safe and stable product. The invention further provides a fibrinogen drug product in dry, e.g., lyophilized form, that has an especially low number of subvisible particles (SVPs), and a batch of such drug products. It suitable for reconstitution of 1 g of fibrinogen in water for injection to obtain a fibrinogen solution comprising 6000 or less SVPs having a size of 10-100 μm and 600 or less SVPs having a size of 25-100 μm. Methods of preparing the drug products of the invention are also disclosed, as well as these drug products for use in treatment of fibrinogen-deficiency.

    PROTEIN NANOSPHERES TO TREAT RENAL FAILURE, DYSFUNCTION OR DAMAGE

    公开(公告)号:US20240325502A1

    公开(公告)日:2024-10-03

    申请号:US18735523

    申请日:2024-06-06

    申请人: Richard C.K. Yen

    发明人: Richard C.K. Yen

    IPC分类号: A61K38/36 A61K9/16 A61P13/12

    摘要: A product and method of using albumin nanoparticles for treating renal failure, dysfunction or damage in a subject by administering a therapeutically effective amount of an albumin nanoparticle suspension containing fibrinogen coated albumin spheres (FAS) to increase a concentration of stem cells or precursors cells in their original site and/or augment a function or effectiveness of them in vivo to mobilize these stem cells or the precursor cells toward a trauma site. The renal failure, dysfunction or damage can be caused by administration of a renal-harmful agent or a chemotherapy drug. The suspension can be administered prophylactically and prior to administration of the agent or drug. The method can include the testing for biological markers, such as osteopontin, in the urine of the subject, and using the concentration information of the biomarkers to predict dosage of the suspension that is effective in further treatment.

    Method for preparation of tissue adhesive patches

    公开(公告)号:US11771799B2

    公开(公告)日:2023-10-03

    申请号:US17850565

    申请日:2022-06-27

    摘要: A method of production of a tissue sealing patch is disclosed. The method comprises applying a vacuum to a heated work surface; applying a solution of a biocompatible polyurethane polymer to the work surface and spreading it over the work surface with a polymer blade; evaporating the solvent; heating the work surface above the softening temperature of the polymer; spreading powdered tissue sealant material over the polymer film; incorporating the tissue sealant material to a depth of 20-60 μm in the film by pressing on a release sheet placed over the powder and polymer film; removing the release sheet from the adhesive patch material; releasing the vacuum; cooling said work surface; and removing the adhesive patch material from said work surface. The biocompatible polymer preferably comprises PEG-caprolactone-lactic acid units connected by urethane linkages, the PEG having a molecular weight of 3000-3500 amu, and a CL:LA:PEG ratio of 34:2:1.