Abstract: The present invention is related to peptides that can be used to reduce the immune response against FVIII or to induce tolerance to human FVIII in patients with, e.g., hemophilia A. Furthermore, the peptides can be used for immunodiagnostic purposes to detect FVIII-specific CD4+T cells to monitor patients with hemophilia A during replacement therapy and during immune tolerance induction therapy.

Abstract: Provided herein are stable co-formulations of immunoglobulin and hyaluronidase that are stable to storage in liquid form at room temperature for at least 6 months and at standard refrigerator temperatures for 1-2 years. Such co-formulations can be used in methods of treating IG-treatable diseases or conditions by subcutaneous administration.

Abstract: Methods for detecting or capturing low-avidity autoantibodies in a biological sample are provided. Target antigen used to assay for the low-avidity autoantibodies of interest is immobilized on a solid phase. The biological sample is contacted under low conductivity condition with the target antigen for which the autoantibodies has specific binding affinity. Binding of the target antigen to the autoantibodies of interest in the biological sample is then detected to ascertain the presence or concentration of the autoantibodies of interest.

Abstract: The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Abstract: The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Abstract: An endoscope or exoscope having a shaft and at least one objective and at least one electronic image recorder for recording an image of an object field, wherein the objective and image recorder are arranged in a distal end region of the endoscope or exoscope, and includes at least one cable, routed within the endoscope or exoscope, for supply of and/or image transmission from the electronic image recorder, wherein the electronic image recorder includes an optical unit, which is rotatable about a first axis of rotation identical or approximately parallel to a direction of view of the scope, and on which the cable is connected and can be wound on a circumferential surface of the optical unit, and wherein the distal end region includes a cavity, in which storage for holding a section of the cable is held.

Abstract: A validatable method for determining a photochemically effective dose for inactivating pathogens in a fluid sample is described herein. In particular, the instant invention covers methods for determining a photochemically effective dose sufficient to inactivate pathogens in a biological sample while leaving biologically active substances of interest unaffected. A batch irradiation reactor effective for inactivating pathogens in biological samples is also described.

Abstract: The present invention is based on the discovery of polyclonal IgG's ability to promote Schwann cell maturation, differentiation, and myelin production. Methods for treating non-idiopathic, demyelinating peripheral neuropathies in mammals, where the neuropathy is not immune-mediated or infection-mediated, through the administration of polyclonal IgG are provided. Types of demyelinating peripheral neuropathies treatable with the present invention include peripheral nerve trauma and toxin-induced peripheral neuropathies. Alternatively, a composition of polyclonal IgGs can be applied directly to a peripheral nerve cell to induce maturation, differentiation into a myelinating state, and myelin expression or promote cell survival.

Abstract: The present invention is related to peptides that can be used to reduce the immune response against FVIII or to induce tolerance to human FVIII in patients with, e.g., hemophilia A. Furthermore, the peptides can be used for immunodiagnostic purposes to detect FVIII-specific CD4+ T cells to monitor patients with hemophilia A during replacement therapy and during immune tolerance induction therapy.

Abstract: The present invention relates, in general, to development of non-human transgenic animals expressing a human blood clotting factor, such as Factor VIII, Factor VII, Factor IX and von Willebrand factor. The invention further provides methods of detecting immunogenic events against human blood clotting factor using the transgenic animals described.

Abstract: The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Abstract: The present invention relates to a method for producing a multi-layer product comprising a) a substrate containing at least one thermoplastic substrate layer and b) at least one protective layer made of a coating composition comprising compounds with at least two functional groups, characterized in that the protective layer(s) are/is applied inline after the production of the substrate containing the substrate layer.

Abstract: The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.

Abstract: An observation instrument has a hollow shaft in whose distal end region there is arranged an optoelectronic imaging system which has on the image entrance side a distal deflection prism whose deflection faces lead an image into an optical lens system which images the image onto the image plane of an image sensor arranged proximally from the lens system, the image sensor having an active region which is situated asymmetrically relative to the outer contour of the image sensor. A first plane, which is defined by the main beam and a first orthogonal on the image plane of the image sensor, and a second plane, which is defined by the main beam and a second orthogonal on the deflection faces of the distal deflection prism, being rotated relative to one another about the main beam in such a way that it is possible to produce a sight cone which is symmetrical relative to a midplane of the hollow shaft and whose image area is situated fully in the active region of the image sensor.

Abstract: The present invention provides, among other aspects, storage stabile aqueous formulations of immunoglobulins with histidine at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing immunoglobulin compositions by formulating with histidine at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of immunoglobulins at mildly acidic to neutral pH useful for parenteral administration.

Abstract: The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.

Abstract: The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.

Abstract: The invention relates to vWF cleaving entities having a molecular weight of 180 kD, 170 kD, 160 kD, 120 kD or 110 kD and an N-terminal amino acid sequence of AAGGILHLELLV, vWF cleaving complexes and methods for their production.

Abstract: The present invention provides, among other aspects, methods for the treatment of Alzheimer's disease in a subject in need thereof, the method including administration of a therapeutically effective amount of a pooled human immunoglobulin G (IgG) composition to a subject with moderately severe Alzheimer's disease, a subject carrying an ApoE4 allele, or both, where the amount of pooled human IgG is from 300 mg/kg to 800 mg/kg body weight of the subject per two week period, and where the amount is administered in one or more doses during the two week period after initiation of a therapeutic regimen. Also provided, are methods for selecting a treatment regimen for a subject with Alzheimer's disease, including diagnosing the severity of the Alzheimer's disease, determining if the subject carries an APOE4 allele, or both, and assigning a treatment regimen including administration of pooled human immunoglobulin G and/or an anti-beta amyloid monoclonal antibody.

Abstract: Methods for producing a mono- or multilayer composite are provided in which one or several layers are applied onto a carrier material by coating, the coated mono- or multilayer composite is dried and rolled up, and the installation is subsequently cleaned. The air circuit in the drying oven is entirely set to fresh air supply, and the drying oven is configured to be cleaned in a controlled manner. All components of the drying oven that come into contact with the product do not have to be removed during cleaning, but can be cleaned-in-place using technology integrated into the drying oven. The drying oven Outer housing is designed so that it can be lifted upwardly. All assembly parts in the drying oven interior are designed to eliminate disassembling for cleaning purposes. Transport rollers within the drying oven are designed as hollow shafts and provided with spraying nozzles.