Provided is a method of manufacturing an IgM containing composition from human blood-plasma depleted of anti-A and/or anti-B immunoglobulins. A human plasma-derived IgM containing composition with 5% or more IgM of the total immunoglobulins is contacted with a macroporous chromatography resin, to which there are coupled ligands comprising GalNAcα1-3(Fucα1-2)Galβ1-4Glc- and/or Galα1-3(Fucα1-2)Galβ1-4Glc-. The flow-through is recovered.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, namely, blood products in the nature of proteins and protein preparations made from human blood, in particular, immunoglobulins and immunoglobulin preparations; Pharmaceutical products for preventing and treating immunological, neurological and hematological disorders; Pharmaceutical products for preventing and treating infectious diseases; Pharmaceutical products for preventing and treating autoimmune diseases; immunomodulatory, anti-inflammatory, anti-allergic, hyposensitizing and detoxifying or toxin-neutralizing medicines
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, namely, blood products in the nature of proteins and protein preparations made from human blood, in particular, immunoglobulins and immunoglobulin preparations; Pharmaceutical products for preventing and treating immunological, neurological and hematological disorders; Pharmaceutical products for preventing and treating infectious diseases; Pharmaceutical products for preventing and treating autoimmune diseases; immunomodulatory, anti-inflammatory, anti-allergic, hyposensitizing and detoxifying or toxin-neutralizing medicines
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals, Medical Preparations, Especially: Serum preparations, in particular serum proteins and solutions containing them; Proteins and protein preparations of human blood, blood plasma or blood serum; Immunoglobulin preparations, Immunoglobulins and Hyperimmune globulin; Pharmaceuticals for immunology, neurology, intensive care medicine, transplant medicine, oncology, the prophylaxis and treatment of viral diseases, the treatment of autoimmune diseases, diseases of the immune system and oncological diseases; Immunsuppressing, immunmodulating, anti-inflammatory, antiallergic, hyposensitizing and detoxifying medicines.
5.
FIBRINOGEN COMPOSITIONS AND METHODS OF PREPARATION
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.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Chemical products for use in industry and science;
biological preparations for use in industry and science,
namely proteins and protein preparations derived from human
blood, blood plasma, or blood serum, coagulation factors;
biological preparations, namely plasma and serum
preparations for cultivating cells, tissue, or organs for
industrial and scientific purposes. Pharmaceutical products, medical and veterinary
preparations; blood products, blood substitute, and blood
plasma substitute; serums preparations for medical purposes,
in particular those containing serum proteins and related
solutions; pharmaceutical proteins and medical protein
preparations made from human blood, blood plasma and blood
serum; human coagulation factors; fibrinogen, fibrinogen
made from human blood plasma, in the nature of
pharmaceutical preparations; pharmaceutical and veterinary
products for hematology, intensive medicine, transplantation
medicine, oncology, for influencing blood diseases, for
influencing blood coagulation.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Chemical products for use in industry and science; biological preparations for use in industry and science, namely proteins and protein preparations derived from human blood, blood plasma, or blood serum, coagulation factors; biological preparations, namely plasma and serum preparations for cultivating cells, tissue, or organs for industrial and scientific purposes.
(2) Pharmaceutical products, medical and veterinary preparations; blood products, blood substitute, and blood plasma substitute; serums preparations for medical purposes, in particular those containing serum proteins and related solutions; pharmaceutical proteins and medical protein preparations made from human blood, blood plasma and blood serum; human coagulation factors; fibrinogen, fibrinogen made from human blood plasma, in the nature of pharmaceutical preparations; pharmaceutical and veterinary products for hematology, intensive medicine, transplantation medicine, oncology, for influencing blood diseases, for influencing blood coagulation.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Biological preparations for use in industry and science, namely proteins and protein preparations derived from human blood, blood plasma, or blood serum, coagulation factors; biological preparations, namely plasma and serum preparations for cultivating cells, tissue, or organs for industrial and scientific purposes. Pharmaceutical, medical and veterinary preparations for hematology, for intensive care medicine, for transplantation medicine, for oncology, for influencing blood diseases, and for influencing blood coagulation; blood products, blood substitute, and blood plasma substitute for medical purposes; blood serums preparations for medical purposes, in particular those containing serum proteins and related solutions; pharmaceutical proteins and medical protein preparations made from human blood, blood plasma and blood serum for hematology, for intensive care medicine, for transplantation medicine, for oncology, for influencing blood diseases, and for influencing blood coagulation; pharmaceutical preparations in the nature of human coagulation factors for hematology, for intensive care medicine, for transplantation medicine, for the treatment of oncology, for influencing blood diseases, and for influencing blood coagulation; fibrinogen and fibrinogen made from human blood plasma, in the nature of pharmaceutical preparations for hematology, for intensive care medicine, for transplantation medicine, for the treatment of oncology, for influencing blood diseases, and for influencing blood coagulation; pharmaceutical and veterinary products for hematology, intensive care medicine, transplantation medicine, oncology, for influencing blood diseases, and for influencing blood coagulation
9.
De-immunized factor VIII molecule and pharmaceutical compositions comprising the same
The present invention relates to the field of therapeutic proteins, in particular, to recombinant coagulation factors. It provides a recombinant Factor VIII (FVIII) protein comprising specific point mutations at defined positions, which serve to reduce the immunogenicity of said FVIII protein, wherein the Factor VIII protein substantially retains its coagulant activity. It further provides nucleic acids encoding said de-immunized protein, cell lines and methods of recombinant preparation as well as pharmaceutical compositions comprising the recombinant FVIII of the invention, which are advantageous for use in treatment of patients with Hemophilia A, particularly those who have not yet been treated with a FVIII product. Additionally, it can be a safe alternative for previously treated patients and even for patients who have developed an immune-response to FVIII, e.g., for immune-tolerance-induction therapy (ITI/ITT) or rescue ITI. The invention also provides an assay for determining immunogenicity of a protein.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 31/675 - Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
10.
Method and Kit for Testing Immunomodulatory Potency of Immunoglobulin Compositions for Treatment of COVID-19
The present invention relates to the field of immunotherapeutics, in particular to a method for characterization and/or quality control of immunotherapeutics. It provides a method of testing potency of an immunoglobulin composition, e.g., plasma or a plasma-derived immunoglobulin composition such as an intravenous immunoglobulin composition (IVIG), as well as to use of a bead coated with an antigen and an antibody specifically bound to said antigen for testing po-tency of an immunoglobulin composition. Said immunoglobulin composition, or immunoglobulin test composition can be an IVIG, particularly and IgA- and/or IgM enriched (also sometimes re-ferred to as IVIG-AM). The potency is tested by the capability of the composition to inhibit an ef-fector function of an Fc-receptor expressing immune effector cell, such as a neutrophil, e.g., a HL60 cell, preferably, production of an inflammatory cytokine such as IL-8. The invention also relates to a method of preparing a standardized immunoglobulin composition, to a kit for carry-ing out the method, as well as a composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of inflammation, e.g., in the context of COVID-19 or pneumonia, e.g., severe community-acquired pneumonia.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/96 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood or serum control standard
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Chemical products for commercial or scientific purposes; biological agents for commercial and scientific purposes, namely: proteins and protein preparations made from human blood, blood plasma or blood serum; biological agents for commercial and scientific purposes, namely: coagulation factors; biological agents for commercial and scientific purposes, namely: plasma and serum preparations. Pharmaceutical products, medical and veterinary preparations; blood substitute, and blood plasma substitute; serum preparations, in particular serum proteins and solutions containing the same; proteins and protein preparations made from human blood, blood plasma or blood serum; coagulation factors; fibrinogen, fibrinogen made from human blood plasma; pharmaceutical and veterinary products for hematology, intensive medicine, transplantation medicine, oncology, for influencing blood diseases, for influencing blood coagulation.
The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations; medical and veterinary drugs;
blood for medical applications; blood plasma substitute and
plasma expanders for medical and veterinary applications;
serum preparations; serum proteins and solutions thereof for
medical and veterinary applications; proteins and protein
preparations made from human blood; blood plasma or blood
serum for medical and veterinary applications; human
albumin, coagulation factors and coagulation inhibitors, in
particular factor VII, factor VIII, factor IX, factor X,
fibrinogen, von Willebrand factor for medical and veterinary
applications; immunoglobulin preparations, immunoglobulins
and hyperimmunoglobulins for medical and veterinary
applications; recombinant proteins, in particular
coagulation factors and monoclonal antibodies for medical
and veterinary applications; pharmaceutical and veterinary
preparations for haematology, immunology, neurology,
intensive medicine, transplantation medicine, oncology, for
influencing blood diseases of the immune system and
oncological diseases; pharmaceutical and veterinary
preparations for preventing and treating viral diseases, for
treating diseases of the immune system, for treating
autoimmune diseases and oncological diseases;
immunosuppressant, immunomodulatory, anti-inflammatory,
antiallergic, hyposensitizing and detoxifying or
toxine-neutralizing medicines.
The present invention relates to the treatment of hemophilia A, in particular to means and methods for subcutaneous administration of Factor VIII (FVIII) proteins. More specifically, the invention relates to FVIII proteins comprising at least one albumin binding domain, which could be shown to have a high bioavailability after subcutaneous administration, in particular, for use in subcutaneous administration to a subject with hemophilia A. The invention also relates to the use of further agents enhancing the bioavailability of FVIII proteins comprising at least one albumin binding domain after subcutaneous administration of such FVIII proteins, in articular human albumin, hyaluronidase and derivatives thereof. The invention also relates to pharmaceutical compositions, combined administration, combined preparations, packages and kits.
The present invention relates to the field of immunology, in particular, to the field of modulation of immune responses, in particular, suppression of immune responses and/or induction of tolerance. It provides a tregitope (regulatory T cell activating epitope) carrying polypeptide based on sequences derived from the Fc part of human IgG, wherein said TCP comprises at least one tregitope heterologous to human IgG that is located within at least one of three specific sequence frames. The invention provides such polypeptides for multiple purposes, e.g., in monomeric or dimeric form, wherein both are optionally be linked to an agent, e.g., to which an immune response is to be modulated or suppressed, or co-administered to such an agent, or for use as a stand-alone therapeutic. Nucleic acids encoding the TCP of the invention, pharmaceutic compositions and uses of said TCP are also provided.
A method of manufacturing a lyophilized plasma-derived Factor VIII product suitable for human administration and a corresponding product is provided. The method comprises: providing a liquid plasma-derived Factor VIII preparation (step a); adjusting the polysorbate 80 content of the preparation to obtain a resulting concentration of 20 to 120 µg polysorbate 80 per mg total protein, preferably 30 to 110 µg per mg total protein, more preferably 40 to 100 µg per mg protein (step b); optionally transferring to one or more suitable container(s) each comprising a dosage unit of Factor VIII (step b1); lyophilization of the preparation obtained in steps b) or b1) (step c); and dry heat treatment of the preparation obtained in step c) to obtain said lyophilized plasma-derived Factor VIII product (step d).
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.
A method for manufacturing a fibrinogen preparation from a fibrinogen containing source derived from blood plasma includes providing a liquid phase containing plasmatic fibrinogen; contacting the liquid phase with a cation exchange chromatography material under conditions resulting in binding of fibrinogen, wherein the liquid phase has a pH in the range of pH 5.6 to pH 7.0 which is near or above the pl of fibrinogen; optionally washing unbound compounds from the cation exchange chromatography material; and eluting the fibrinogen from the cation exchange material. The method is also suitable for reduction of von-Willebrand-factor.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical preparations; Pharmaceutical products, medical preparations, namely proteins and protein preparations made from human blood, blood plasma or blood serum; Pharmaceutical products, medical preparations, namely immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; Pharmaceutical products for haematology, immunology, neurology, intensive medicine, transplantation medicine, oncology, for influencing the immune system; Pharmaceutical products for preventing and treating viral diseases, pharmaceutical products for treating diseases of the immune system, pharmaceutical products for treating autoimmune diseases, pharmaceutical products for treating oncological diseases; Immunosuppressant, immunomodulatory or anti-inflammatory medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical preparations; Pharmaceutical products, medical preparations, namely proteins and protein preparations made from human blood, blood plasma or blood serum; Pharmaceutical products, medical preparations, namely immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; Pharmaceutical products for haematology, immunology, neurology, intensive medicine, transplantation medicine, oncology, for influencing the immune system; Pharmaceutical products for preventing and treating viral diseases, pharmaceutical products for treating diseases of the immune system, pharmaceutical products for treating autoimmune diseases, pharmaceutical products for treating oncological diseases; Immunosuppressant, immunomodulatory or anti-inflammatory medicines.
The present invention relates to a recombinant Factor VIII protein comprising, in a single chain, a heavy chain portion comprising an A1 and an A2 domain and a light chain portion comprising an A3, C1 and C2 domain of Factor VIII, wherein the B-domain is partially deleted in two deletions, the first leading to the presence of a defined processing sequence cleavable by thrombin, and the second leading to absence of the furin cleavage recognition site at position R1664-R1667. An internal fragment of the B-domain is maintained Nucleic acids encoding said protein, host cells and methods of preparing the protein are also provided, as well as a pharmaceutical composition comprising the protein, nucleic acid or host cell, which may be used for treatment of hemophilia A.
A process for the preparation of pharmaceutically acceptable immunoglobulin compositions from plasma-derived immunoglobulin fractions which allows the parallel preparation of immunoglobulin compositions enriched in IgG, IgM and IgA. In this process, immunoglobulin contained in Cohn fraction I/II/III or Kistler Nitschmann fraction A+I is resolubilized at conductivities of at least 1 mS/cm, and following removal of contaminating protein the resolubilized immunoglobulin is subjected to anion exchange chromatography to obtain IgG- and IgM/IgA-enriched immunoglobulin compositions. The IgG-enriched immunoglobulin composition is further subjected to treatment with a cation exchange material to obtain an immunoglobulin composition having a reduced properdin content.
The present invention relates to the field of immunotherapeutics. It provides a method for characterisation and quality control, in particular for determining the potency of an immunoglobulin composition comprising immunoglobulins derived from a plurality of human donors, the method comprising contacting the immunoglobulin composition with pneumolysin, adding erythrocytes to the immunoglobulin composition and determining lysis of the erythrocytes. The invention also provides a corresponding use of pneumolysin, as well as a kit and composition useful in said method. The method can be used for quality control of immunoglobulin concentrate, e.g., of an IgM-containing immunoglobulin composition comprising IgM, IgA and IgG antibodies, and in a method of preparing an immunoglobulin composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of pneumonia, e.g., severe community-acquired pneumonia, which may be caused, e.g., by Streptococcus pneumoniae.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Biological preparations for use in industry and science, namely, proteins and protein preparations made from human blood, blood plasma or blood serum, in particular human albumin, coagulation factors and immunoglobulins; recombinant proteins for industrial and scientific use; plasma fractions in the nature of biological preparations for industrial and scientific use; excipients for the stabilization of medicines, in particular human albumin for industrial and scientific purposes Pharmaceutical preparations for treating infectious diseases and diseases of the immune system, namely, proteins and protein preparations made from human blood, blood plasma or blood serum; pharmaceutical preparations for the treatment or prevention of blood or bleeding disorders, namely, human albumin, coagulation factors and coagulation inhibitors, in particular factor VIII, factor IX, factor X, fibrinogen; pharmaceutical preparations for the treatment or prevention of blood or bleeding disorders, namely, immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; pharmaceutical preparations for the treatment or prevention of blood or bleeding disorders, namely, recombinant proteins, in particular coagulation factors and monoclonal antibodies; pharmaceutical preparations for haematology, immunology, neurology, intensive medicine, transplantation medicine, oncology for the prevention and treatment of immune system-related diseases and disorders, neurological diseases and disorders, cancer and infections; pharmaceutical preparations for preventing and treating viral diseases, for treating diseases of the immune system, for treating autoimmune diseases and oncological diseases; immunosuppressant, immunomodulatory, anti-inflammatory, antiallergic, hyposensitizing and detoxifying and toxin-neutralizing medicines
25.
METHOD AND KIT FOR TESTING IMMUNOMODULATORY POTENCY OF IMMUNOGLOBULIN COMPOSITIONS, E.G., FOR TREATMENT OF COVID-19
The present invention relates to the field of immunotherapeutics, in particular to a method for characterization and/or quality control of immunotherapeutics. It provides a method of testing potency of an immunoglobulin composition, e.g., plasma or a plasma-derived immunoglobulin composition such as an intravenous immunoglobulin composition (IVIG), as well as to use of a bead coated with an antigen and an antibody specifically bound to said antigen for testing po- tency of an immunoglobulin composition. Said immunoglobulin composition, or immunoglobulin test composition can be an IVIG, particularly and IgA- and/or IgM enriched (also sometimes re- ferred to as IVIG-AM). The potency is tested by the capability of the composition to inhibit an ef- fector function of an Fc-receptor expressing immune effector cell, such as a neutrophil, e.g., a HL60 cell, preferably, production of an inflammatory cytokine such as IL-8. The invention also relates to a method of preparing a standardized immunoglobulin composition, to a kit for carry- ing out the method, as well as a composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of inflammation, e.g., in the context of COVID-19 or pneumonia, e.g., severe community-acquired pneumonia.
G01N 33/96 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood or serum control standard
C07K 16/06 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies from serum
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical products, namely, blood
products, medical preparations; in particular: blood
products, serum preparations, in particular serum proteins
and solutions containing the same; proteins and protein
preparations made from human blood, blood plasma or blood
serum; in particular immunoglobulin preparations,
immunoglobulins and hyperimmunoglobulins; pharmaceutical
products for immunology, neurology, intensive medicine,
transplantation medicine, oncology; pharmaceutical products
for preventing and treating viral diseases, diseases of the
immune system, autoimmune diseases and oncological diseases;
immunosuppressant, immunomodulatory, anti-inflammatory,
antiallergic, hyposensitizing and detoxifying or
toxine-neutralizing medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical products, namely, blood
products, medical preparations; in particular: blood
products, serum preparations, in particular serum proteins
and solutions containing the same; proteins and protein
preparations made from human blood, blood plasma or blood
serum; in particular immunoglobulin preparations,
immunoglobulins and hyperimmunoglobulins; pharmaceutical
products for immunology, neurology, intensive medicine,
transplantation medicine, oncology; pharmaceutical products
for preventing and treating viral diseases, diseases of the
immune system, autoimmune diseases and oncological diseases;
immunosuppressant, immunomodulatory, anti-inflammatory,
antiallergic, hyposensitizing and detoxifying or
toxine-neutralizing medicines.
28.
PROTEIN COMPRISING AT LEAST ONE REGULATORY T CELL ACTIVATING EPITOPE
The present invention relates to the field of immunology, in particular, to the field of modulation of immune responses, in particular, suppression of immune responses and/or induction of tolerance. It provides a tregitope (regulatory T cell activating epitope) carrying polypeptide based on sequences derived from the Fc part of human IgG, wherein said TCP comprises at least one tregitope heterologous to human IgG that is located within at least one of three specific sequence frames. The invention provides such polypeptides for multiple purposes, e.g., in monomeric or dimeric form, wherein both are optionally be linked to an agent, e.g., to which an immune response is to be modulated or suppressed, or co-administered to such an agent, or for use as a stand-alone therapeutic. Nucleic acids encoding the TCP of the invention, pharmaceutic compositions and uses of said TCP are also provided.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products and medical products, namely blood for medical purposes; medical preparations, namely blood for medical purposes; pharmaceutical proteins and medical protein preparations made from human blood, blood plasma and blood serum, namely, immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins, all being pharmaceutical preparations for preventing and treating of immune system related diseases and disorders, neurological diseases and disorders, cancer, infections; pharmaceutical preparations for immunology, neurology, intensive medicine, transplantation medicine, oncology, namely pharmaceutical preparations for the prevention and treatment of immune system-related diseases and disorders, neurological diseases and disorders, cancer, and infections; pharmaceutical preparations for preventing and treating viral diseases, diseases of the immune system, autoimmune diseases and oncological diseases; immunosuppressant, immunomodulatory, anti-inflammatory, antiallergic, hyposensitizing and detoxifying or toxin-neutralizing medicines, namely pharmaceutical preparations for treatment of immune-related diseases and disorders and for treatment of allergies and for treatment of infections
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products and medical products, namely blood for medical purposes; medical preparations, namely blood for medical purposes; pharmaceutical proteins and medical protein preparations made from human blood, blood plasma and blood serum, namely, immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins, all being pharmaceutical preparations for preventing and treating of immune system related diseases and disorders, neurological diseases and disorders, cancer, infections; pharmaceutical preparations for immunology, neurology, intensive medicine, transplantation medicine, oncology, namely pharmaceutical preparations for the prevention and treatment of immune system-related diseases and disorders, neurological diseases and disorders, cancer, and infections; pharmaceutical preparations for preventing and treating viral diseases, diseases of the immune system, autoimmune diseases and oncological diseases; immunosuppressant, immunomodulatory, anti-inflammatory, antiallergic, hyposensitizing and detoxifying or toxin-neutralizing medicines, namely pharmaceutical preparations for treatment of immune-related diseases and disorders, for treatment of allergies, and for treatment of infections
The present invention relates to the treatment of hemophilia A, in particular to means and methods for subcutaneous administration of Factor VIII (FVIII) proteins. More specifically, the invention relates to FVIII proteins comprising at least one albumin binding domain, which could be shown to have a high bioavailability after subcutaneous administration, in particular, for use in subcutaneous administration to a subject with hemophilia A. The invention also relates to the use of further agents enhancing the bioavailability of FVIII proteins comprising at least one albumin binding domain after subcutaneous administration of such FVIII proteins, in particular human albumin, hyaluronidase and derivatives thereof. The invention also relates to pharmaceutical compositions, combined administration, combined preparations, packages and kits.
The invention is concerned with manufacturing a fibrinogen preparation from a fibrinogen containing source derived from blood plasma. The method comprising the steps, providing a liquid phase containing plasmatic fibrinogen; contacting the liquid phase with a cation exchange chromatography material under conditions resulting in binding of fibrinogen, wherein the liquid phase has a pH in the range of pH 5.6 to pH 7.0 which is near or above the pI of fibrinogen; optionally washing unbound compounds from the cation exchange chromatography material; eluting the fibrinogen from the cation exchange material. The method is also suitable for reduction of von-Willebrand-factor.
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations, Medicinal products, Medical preparations; In particular blood preparations, serum preparations, in particular serum proteins and solutions containing serum proteins; Proteins and protein preparations made of human blood; Blood plasma or Blood serum; In particular immunoglobulin preparations, Immunoglobulins and Hyperimmune globulin; Pharmaceutical goods, including for immunology, neurology, intensive medicine; For the prevention and treatment of viral diseases and immune disorders; immunomodulatory, anti-inflammatory and detoxifying or toxine-neutralizing medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical products, namely, blood products, medical preparations; in particular: Blood products, serum preparations, in particular serum proteins and solutions containing the same; proteins and protein preparations made from human blood, blood plasma or blood serum; in particular immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; Pharmaceutical products for immunology, neurology, intensive medicine, transplantation medicine, oncology; Pharmaceutical products for preventing and treating viral diseases, diseases of the immune system, autoimmune diseases and oncological diseases; immunosuppressant, immunomodulatory, anti-inflammatory, antiallergic, hyposensitizing and detoxifying or toxine-neutralizing medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, medical products, namely, blood products, medical preparations; in particular: Blood products, serum preparations, in particular serum proteins and solutions containing the same; proteins and protein preparations made from human blood, blood plasma or blood serum; in particular immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; Pharmaceutical products for immunology, neurology, intensive medicine, transplantation medicine, oncology; Pharmaceutical products for preventing and treating viral diseases, diseases of the immune system, autoimmune diseases and oncological diseases; immunosuppressant, immunomodulatory, anti-inflammatory, antiallergic, hyposensitizing and detoxifying or toxine-neutralizing medicines.
The present invention relates to recombinant coagulation factors, in particular, recombinant Factor VIII (FVIII) proteins having an increased half-life. They comprise a heavy chain portion and a light chain portion of Factor VIII and at least two albumin binding domains, wherein at least one albumin binding domain is C-terminal to the heavy chain portion and at least one albumin binding domain is C-terminal to the light chain portion. If the protein is a single chain protein, the albumin binding domain(s) C-terminal to the heavy chain portion is/are N-terminal to the light chain portion. The protein of the invention may also be a de-immunized Factor VIII protein comprising specific point mutations at defined positions, which serve to reduce the immunogenicity, wherein the protein substantially retains its coagulant activity. The invention also relates to nucleic acids encoding the proteins of the invention, methods of producing them and pharmaceutical compositions comprising any of these, wherein the pharmaceutical composition preferably is for use in treatment of hemophilia A.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical products, namely, blood products, in the nature of proteins and protein preparations made from human blood, in particular immunoglobulins and immunoglobulin preparations, Pharmaceutical products for preventing and treating immunological, neurological and hematological disorders; Pharmaceutical products for preventing and treating infectious diseases, Pharmaceutical products for preventing and treating autoimmune diseases; Immunomodulatory, anti-inflammatory, anti-allergic, hyposensitizing, detoxifying, and toxine-neutralizing medicines
40.
METHOD AND KIT FOR TESTING POTENCY OF IMMUNOGLOBULIN COMPOSITIONS
The present invention relates to the field of immunotherapeutics. It provides a method for characterisation and quality control, in particular for determining the potency of an immunoglobulin composition comprising immunoglobulins derived from a plurality of human donors, the method comprising contacting the immunoglobulin composition with pneumolysin, adding erythrocytes to the immunoglobulin composition and determining lysis of the erythrocytes. The invention also provides a corresponding use of pneumolysin, as well as a kit and composition useful in said method. The method can be used for quality control of immunoglobulin concentrate, e.g., of an IgM-containing immunoglobulin composition comprising IgM, IgA and IgG antibodies, and in a method of preparing an immunoglobulin composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of pneumonia, e.g., severe community-acquired pneumonia, which may be caused, e.g., by Streptococcus pneumoniae.
C07K 16/12 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from bacteria
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
C07K 14/315 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria from Streptococcus (G), e.g. Enterococci
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical preparations and substances for diagnostic kits,
namely, buffer, salts, solvents and reactants;
pharmaceutical and veterinary preparations; preparations for
health care; dietetic preparations for medical purposes;
baby nutrition; plasters; medical dressings; pharmaceutical
preparations for hematology, intensive care, transplantation
medicine and for influencing coagulation; immunoglobulin
preparations; serum preparations, in particular serum
proteins and solutions containing these; albumin for medical
use; blood products, blood substitutes; plasma substitutes
and expanders; vaccines, in particular based on
immunoglobulins; antibiotics, narcotics, medicaments for the
treatment of the central nervous system; medicaments for the
treatment of cordial and circulation disorders; medicaments
for pulmonary treatment; medicaments for urologic treatment;
medicaments for treatment of digestive organs and adjacent
glands; hormons for medical purposes; vitamins;
immunosuppressive antiinflammatory, antiallergic,
hyposensitizing and detoxifying medicaments; dermatologic,
ophthalmologic and otologic medicaments; antibodies, in
particular monoclonal antibodies for use in in-vitro
diagnostics and in therapy; in vitro diagnostics for medical
purposes; in-vitro diagnostics, in particular for proteins
such as antibodies, microsomal antibodies or
immunoglobulins, or nucleic acids, for blood group
diagnostics or antibody determination, tissue typology, cell
diagnostics, microbiological diagnostics, and hygiene
control for medical purposes; test kits and reagents, in
particular for blood group diagnostics, tissue typology,
cell diagnostics, microbiological diagnostics, compound
analysis, in particular of toxic compounds for medical
purposes, in particular test kits based on serology and
immunogenetics and reagents therefor for medical purposes;
DNA samples; infection diagnostics; ready-to-use culture
media for bacteria; culture media for bacteria and
components thereof.
The present invention relates to a recombinant Factor VIII protein comprising, in a single chain, a heavy chain portion comprising an A1 and an A2 domain and a light chain portion comprising an A3, C1 and C2 domain of Factor VIII, wherein the B-domain is partially deleted in two deletions, the first leading to the presence of a defined processing sequence cleavable by thrombin, and the second leading to absence of the furin cleavage recognition site at position R1664-R1667. An internal fragment of the B-domain is maintained. Nucleic acids encoding said protein, host cells and methods of preparing the protein are also provided, as well as a pharmaceutical composition comprising the protein, nucleic acid or host cell, which may be used for treatment of hemophilia A.
C12N 15/00 - Mutation or genetic engineeringDNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purificationUse of hosts therefor
The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations, medical preparations; Blood products, serum preparations; serum proteins and solutions containing the same; proteins and protein preparations made from human blood, blood plasma or blood serum; immunoglobulin preparations, immunoglobulins and hyperimmunoglobulins; Pharmaceutical products for immunology, intensive medicine; for preventing and treating viral diseases, for treating diseases of the immune system; immunomodulatory, anti-inflammatory and detoxifying or toxine-neutralizing medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals, Medical preparations, Especially: Serum preparations, in particular serum proteins and solutions containing them; Proteins and protein preparations of human blood, blood plasma or blood serum; Immunoglobulin preparations, Immunoglobulins and Hyperimmune globulin; Pharmaceuticals for immunology, neurology, intensive care medicine, transplant medicine, oncology, the prophylaxis and treatment of viral diseases, the treatment of autoimmune diseases, diseases of the immune system and oncological diseases; Immunosuppressing, immunomodulating, anti-inflammatory, antiallergic, hyposensitising and detoxifying medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals, Medical preparations, Especially: Serum preparations, in particular serum proteins and solutions containing them; Proteins and protein preparations of human blood, blood plasma or blood serum; Immunoglobulin preparations, Immunoglobulins and Hyperimmune globulin; Pharmaceuticals for immunology, neurology, intensive care medicine, transplant medicine, oncology, the prophylaxis and treatment of viral diseases, the treatment of autoimmune diseases, diseases of the immune system and oncological diseases; Immunosuppressing, immunomodulating, anti-inflammatory, antiallergic, hyposensitising and detoxifying medicines.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals, Medical preparations, Especially: Serum preparations, in particular serum proteins and solutions containing them; Proteins and protein preparations of human blood, blood plasma or blood serum; Immunoglobulin preparations, Immunoglobulins and Hyperimmune globulin; Pharmaceuticals for immunology, neurology, intensive care medicine, transplant medicine, oncology, the prophylaxis and treatment of viral diseases, the treatment of autoimmune diseases, diseases of the immune system and oncological diseases; Immunosuppressing, immunomodulating, anti-inflammatory, antiallergic, hyposensitising and detoxifying medicines.
48.
DE-IMMUNIZED FACTOR VIII MOLECULE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME
The present invention relates to the field of therapeutic proteins, in particular, to recombinant coagulation factors. It provides a recombinant Factor VIII (FVIII) protein comprising specific point mutations at defined positions, which serve to reduce the immunogenicity of said FVIII protein, wherein the Factor VIII protein substantially retains its coagulant activity. It further provides nucleic acids encoding said de-immunized protein, cell lines and methods of recombinant preparation as well as pharmaceutical compositions comprising the recombinant FVIII of the invention, which are advantageous for use in treatment of patients with Hemophilia A, particularly those who have not yet been treated with a FVIII product. Additionally, it can be a safe alternative for previously treated patients and even for patients who have developed an immune-response to FVIII, e.g., for immune-tolerance-induction therapy (ITI/ITT) or rescue ITI. The invention also provides an assay for determining immunogenicity of a protein.
A process for the preparation of pharmaceutically acceptable immunoglobulin compositions from plasma-derived immunoglobulin fractions which allows the parallel preparation of immunoglobulin compositions enriched in IgG, IgM and IgA. In this process, immunoglobulin contained in Cohn fraction I/II/III or Kistler Nitschmann fraction A+I is resolubilized at conductivities of at least 1 mS/cm, and following removal of contaminating protein the resolubilized immunoglobulin is subjected to anion exchange chromatography to obtain IgG- and IgM/IgA-enriched immunoglobulin compositions. The IgG-enriched immunoglobulin composition is further subjected to treatment with a cation exchange material to obtain an immunoglobulin composition having a reduced properdin content.
The present disclosure relates to the field of oncology, more particularly to immune oncology combination therapies for use in the treatment of malignant melanoma. In particular, the present invention relates to an interleukin 10 (IL-10) neutralizing antibody or fragment thereof for use in combination with a PD-1 inhibitor in the treatment of melanoma in a mammal, in particular in a human. Further provided is an interleukin 10 (IL-10) neutralizing antibody or fragment thereof for use in the treatment of melanoma in a mammal which is undergoing treatment with a PD-1 inhibitor. Similarly, the present disclosure further relates to a PD-1 inhibitor for use in combination with an interleukin 10 (IL-10) neutralizing antibody or fragment thereof in the treatment of melanoma in a mammal. Further disclosed is a PD-1 inhibitor for use in the treatment of melanoma in a mammal who is undergoing treatment with an interleukin 10 (IL-10) neutralizing antibody or fragment thereof.
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
51.
IgG, IgA and IgM antibody preparations, method of making and method of use in treatment
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
Described is a process for the preparation of pharmaceutically acceptable immunoglobulin compositions from plasma-derived immunoglobulin fractions which allows the parallel preparation of immunoglobulin compositions enriched in IgG, IgM and IgA. In this process, immunoglobulin contained in Cohn fraction I/II/III or Kistler Nitschmann fraction A+I is resolubilized at conductivities of at least 1 mS/cm, and following removal of contaminating protein the resolubilized immunoglobulin is subjected to anion exchange chromatography to obtain IgG- and IgM/IgA-enriched immunoglobulin compositions. The IgG-enriched immunoglobulin composition is further subjected to treatment with a cation exchange material to obtain an immunoglobulin composition having a reduced properdin content.
The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations, In particular preparations for treating or preventing rabies infections; immunoglobulin preparations for medical use; All of the aforesaid goods being intended solely for use by humans.
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5 % IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
The present invention provides for a new therapeutic capable of treating HCV infections and of avoiding HCV recurrence in liver transplant patients, using a new human HCV- immunoglobulin preparation and applying a specific dosage regimen. This treatment schedule can potentially result in a cure for HCV patients such that HCV re-infection or recurrence of disease is gravely diminished or even absent.
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
Provided is a method for treating a disease associated with target cells expressing CD 138 comprising: administering to a subject, in particular a human subject, in need thereof an immunoconjugate comprising at least one engineered targeting antibody targeting CD138 expressing cells, and at least one effector molecule, wherein said engineered targeting antibody is functionally attached to said effector molecule to form said immunoconjugate, wherein preferably at least a part of the engineered targeting antibody confers lgG4 isotype properties, wherein the immunoconjugate is administered in a multiple dose regimen comprising at least two doses, wherein the aggregate dose administered within an active treatment cycle is an aggregate maximum tolerable dose (AMTD) or a fraction of the AMTD and wherein said AMTD and/or said fraction exceeds the dose resulting in dose limiting toxicity (DLT) when the immunoconjugate is administered as a single dose, including as part of a multiple single dose regimen and/or exceeds the maximum tolerable dose (MTD) when the immunoconjugate is administered as a single dose, including as part of a multiple single dose regimen within said active treatment cycle.
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
A process is provided for the preparation of an immunoglobulin composition from a plasma fraction having immunoglobulins, and antibody preparations prepared utilizing the process.
An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the prevention and treatment of infectious diseases; Pharmaceuticals, namely, immunoglobulines; [ Blood plasma; ] Blood plasma protein
Provided is a process for the preparation of an immunoglobulin composition from a plasma comprising immunoglobulins, and antibody preparations prepared utilizing the process.
Provided is an antibody preparation suitable for intravenous administration in humans comprising IgG, IgA and at least 5% IgM antibodies by weight of the total amount of antibodies, wherein the preparation is prepared from human plasma, wherein the antibody preparation has specific complement activating activity and wherein in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically the antibody preparation generates substantially no C5a and/or substantially no C3a. Further provided are medical uses of the antibody preparation.
Provided is a humanized or chimeric antibody or fragment thereof capable of binding to interleukin-10 (IL-10), wherein said antibody or fragment thereof is capable of being administered to a subject in the absence of an intolerable increase in the level of pro-inflammatory cytokines. Further provided are methods of treatment involving the use of the antibody or fragment thereof.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
67.
HUMANIZED ANTI-IL-10 ANTIBODIES FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Provided is a humanized or chimeric antibody or fragment thereof capable of binding to interleukin-10 (IL-10), wherein said antibody or fragment thereof: (i) binds to the same region of IL-10 as the IL-10 receptor α (IL-I10Ra) and is not capable of binding IL-10 when the IL-10 is bound to the IL- 10 receptor; and (ii) binds to IL-10 in homodimeric form by binding a discontinuous epitope comprising residues of both monomers. Further provided are related products and methods involving the use of the antibody or fragment thereof.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
Provided are methods of screening to identify molecules capable of binding to CD4 and capable of activating CD4+CD25+ regulatory T cells. Further provided are antibodies and antibody fragments capable of activating CD4+CD25+ regulatory T cells and methods and uses involving the antibodies and fragments thereof.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
Disclosed are methods and treatment regimes that include the administration of immunconjugates targeting CD138 to combat diseases. The immunoconjugate is either used as the sole active ingredient, as part of a treatment regime or as part of an anticancer combination.
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
The provision of pharmaceutical compositions and kits comprising an agent capable of activating CD4+CD25+ regulatory T cells and methotrexate, and methods of treatment and medical uses utilising the same.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the prevention and treatment of infectious diseases; Pharmaceuticals, namely, immunoglobulines; [ Blood plasma; ] Blood plasma protein
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the prevention and treatment of infectious diseases; Pharmaceuticals, namely, immunoglobulines; [ Blood plasma; ] Blood plasma protein
The provision of a pharmaceutical composition for treating an autoimmune disease comprising a pharmaceutically acceptable carrier and an agent capable of activating CD4+CD25+ regulatory T cells, wherein the composition is to be administered to a subject in a dose of the agent from 10 mg to 200 mg.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
Provision of a pharmaceutical composition for treating an autoimmune disease comprising a pharmaceutically acceptable carrier and an agent capable of activating CD4+CD25+ regulatory T cells, wherein the composition is to be administered to a subject in a dose of the agent from 0.2 mg to 30 mg.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
The provision of a pharmaceutical composition for treating an autoimmune disease comprising a pharmaceutically acceptable carrier and an agent capable of activating CD4+CD25+ regulatory T cells, wherein the composition is to be administered to a subject at most every 3 days.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61P 37/06 - Immunosuppressants, e.g. drugs for graft rejection
Disclosed is a human murine chimeric antibody which substantially retains the antigen binding region of its murine counterpart and displays improved binding affinities to the antigen and/or more homogenous binding to target cells.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
Disclosed are immunoconjugates having in particular specificity for CD138 expressed on target cells and which display homogenous targeting. The immunoconjugates may be sterially hindered and/or contain a cleavable linker.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
78.
METHOD OF DECREASING CYTOTOXIC SIDE-EFFECTS AND IMPROVING EFFICACY OF IMMUNOCONJUGATES
Disclosed are methods, compositions and kits for improving targeting, in particular tumor targeting, of immunoconjugates. The method and composition relies on the sequestration of non-target cells that also express the antigen the immunoconjugate targets. Sequestration of those non-target cells in a variety of ways is disclosed. The methods, compositions and kits allow appropriate sequestration of non-target cells while maintaining a high degree of effectivness of the immunoconjugates against target cells.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
79.
METHODS AND AGENTS FOR IMPROVING TARGETING OF CD138 EXPRESSING TUMOR CELLS
Disclosed are immunoconjugates having specificity for CD138 that diminish adhesion of CD138 expressing tumor cells to stroma cells and methods of using the same. This deminished adhesion renders the tumor cells not only susceptible to the immunconjugate, but also to other agents, in particular cytotoxic agents.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
80.
PERFUSION DEVICE FOR HOLLOW ORGANS, AND THE USE THEREOF FOR THE PERFUSION OF AN EXPLANTED HOLLOW ORGAN
A perfusion liquid is suctioned from a perfusion liquid reservoir (16) through the automatic two-way valve (4) by drawing a syringe (5) serving as the perfusion liquid displacement device. For this purpose, the connection from the syringe (5) to the cannula (14) is closed by the two-way valve (4). The two-way valve (4) closes the connection to the perfusion liquid reservoir due to the pressure increase during the insertion of the syringe plunger and opens the connection from the syringe (5) to the cannula (14). A pressure relief valve (7) is attached at the T piece (6), exposing a discharge line (8) in case a threshold pressure is exceeded. A check valve (11) is attached at the extension of the cannula (14), preventing the backflow from the cannula (14) into the remaining system.
A61M 5/48 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for varying, regulating, indicating or limiting injection pressure
A61B 19/00 - Instruments, implements or accessories for surgery or diagnosis not covered by any of the groups A61B 1/00-A61B 18/00, e.g. for stereotaxis, sterile operation, luxation treatment, wound edge protectors(protective face masks A41D 13/11; surgeons' or patients' gowns or dresses A41D 13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M 1/00)
The particle counter (1) is equipped with a scroll pump (2) adapted to create a gas flow through the measurement chamber (6) with a maximum flow rate of at least 50 liters per minute. Light (10) scattered from particles entrained in the gas flow is collected by an optical system (11). The product of the smallest diameter of the minimum aperture and the magnification amounts to at least 2 mm. Especially preferred is a minimum aperture with a smallest diameter of at least 2.5 mm and a magnification of at least 1.5. The optical system (11) images a projection of the measurement volume created by intersection of the gas flow and the beam of light (8) onto the active area (12) of the sensor module (13). The sensor module 13 contains a photomultiplier- tube (PMT). Both sensitivity and accuracy of the particle counter are improved using a larger aperture and greater magnification, which is made possible by use of the photomultipiier tube.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
20 - Furniture and decorative products
35 - Advertising and business services
42 - Scientific, technological and industrial services, research and design
Goods & Services
Chemicals used in industry and science; in-vitro diagnostics for industrial and scientific purposes, in particular for proteins,antibodies, monoclonal antinbodies, immunoglobulins, or nucleic acids, for the diagnosis of bloodgroups and the determination of antibodies, asecertaining tissue types, cell diagnosis, microbiological diagnosis, and hygiene control; test kits and reagents for non-medical purposes, in particular for blood group diagnosis, determination of antibodies, ascertaining tissue type, cell diagnosis, microbiological diagnosis, identification of substances, in particular of toxins, in particular test kits on a serological basis or based on genetic immunity and reagents for them; enzyme-linked immunosorbent assays (ELISA) and reagents therefor, for non-medical purposes; prepared culture media, not for medical purposes; culture media and components of the same, for non-medical purposes; systems for determining resistance and for the identification of precursors included in class 1 and for non-medical purposes; buffers, salts, solvents and reagents for the aforesaid test kits; plates and microtitre plates, in particular for cell typing, blood and virus diagnostics; DNA samples and infection diagnostic preparations, for non-medical purposes. Pharmaceutical and veterinary preparations; preparations for health care; dietetic substances adapted for medical use; food for babies; plasters; materials for dressings; pharmaceutical products for haematology, intensive medicine, transplant surgery and for influencing the clotting of blood; immunoglobulin preparations; serum preparations, in particular serum proteins and solutions containing them; human albumen; blood products and blood substitutes; blood plasma substitute and plasma expander; vaccines, especially those based on immunoglobulin; blood coagulants, especially clotting factors; antibiotics, narcotics and medications for treating the central nervous system; medications for treating heart and circulatory disorders; medications for treating the bronchia; medications for urological treatment; medications for treating the digestive organs and the associated glands; medications for treating auto-immune disorders, disorders of the immune system and oncological conditions; hormones; vitamins; immunosuppressive, anti-inflammatory, anti-allergenic, hypo-sensitivising and detoxificant medications; dermatological, ophthalmological and otological medications; products for in-vivo and in-vitro diagnostic purposes; antibodies, especially monoclonal antibodies for use in in-vivo diagnostics and for therapeutic purposes; in vitro diagnostic agents for medical use, expecially for proteins, such as antibodies, monoclonal antibodies or immunoglobulins, or nucleic acids, for the diagnosis of bloodgroups and identification of antibodies,establishment of tissue types, cell diagnosis, microbiological diagnostics and hygiene control; test kits and reagents for medical purposes, in particular for blood group diagnostics, identification of antibodies, identification of tissue types, cell diagnosis, microbiological diagnostics, identification of substances, in particular of toxic substances, in particular test kits on a serological and immunogenetic basis and reagents for the same; enzyme-linked immunosorbent assays (ELISA) and reagents therefor, for medical purposes; prepared culture media, for medical purposes; culture media and constituents thereof for medical purposes; systems for determining residence and identifying precursors for medical purposes; buffers, salts, solvent materials and reagents for the above-named test kits, plates and microtitre plates, in particular for cell typing, blood and virus diagnostics for medical purposes; DNA probes and infection diagnostic preparations, for medical purposes. Measuring, signalling, checking (supervision) and weighing apparatus and instruments; measuring and monitoring apparatus for determining and quantifying micro-organisms in the air, in fluids and on surfaces; measuring and monitoring apparatus for determining and quantifying substances, in particular blood sugar, blood or breath alcohol, toxic substances, oxygen and constituents of blood such as haemoglobin; apparatus for determining the quantity of germs in the air and for hygiene monitoring; diagnostic analysis apparatus for non-medical purposes. Surgical, medical, dental and veterinary apparatus and instruments; bottles and containers for storage and preserving transfusion and infusion solutions; instruments, apparatus or devices for extracting and identifying micro-organisms in various media; apparatus for the (micro) identification of relevant, in particular marked substances for diagnostic and medical purposes; transfusion and infusion devices and equipment; blood warmers; devices for the extraction and treatment of cells including of materials to be used only once; diagnostic analysis apparatus for medical purposes. Plastic containers for the collection, storage and utilisation of blood; plastic containers for the separation of blood into its constituent parts; plastic containers for plasma substitutes and for infusion solutions, plastic ready-made packages for the receipt, separating and dosage of blood and blood constituents includign microfilter packages. Retail services in connection with these goods: immunoglobulins, clotting factors, monoclonal antibodies, protein solutions liquid reagents, microtitre plates, bedside cards, instruments and accessories as well as software, reagents and materials for diagnostic purposes, instruments and accesories with software, reagents and materials for transplantations, transfusions, hygiene control, tissue typing, blood diagnostics and for the diagnosis of infectious diseases. Biology, chemistry or biochemistry services; services of medical, bacteriological and chemical laboratories; hygiene monitoring; research, development and consultancy in the field of diagnostics, such as the provision and development of reagents and test kits, in particular based on serology and immunogenetics; expert diagnosis of viruses; research, development and consultancy in the field of medical technology; medical research, development and consultancy, in particular in the field of haematology, intensive medicine, transplant medicine, blood clotting, virus diseases (AIDS research) and anaesthesia.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
11 - Environmental control apparatus
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Pharmaceutical and veterinary preparations; pharmaceuticals, therapeutic preparations, diagnostic preparations, in-vitro diagnostics for medicinal and medical science purposes; in-vitro diagnostic preparations for proteins, such as antibodies, microsomal antibodies or immunoglobulins or nucleic acids, for blood group diagnostics, antibody determination and tissue typing; test kits and reagents for blood group diagnostics, antibody determination, tissue typing, cell diagnostics, microbiological diagnostics and substance determination; test kits based on serology and immunogenetics and reagents therefor. Medical devices for performing laboratory tests in doctors' and hospital laboratories; diagnostic devices for medical and therapeutic purposes; technical products for transplants and transfusions; surgical implants of artificial materials; medical clean room and sterile room devices, medical devices for therapeutic purposes; electromedical devices and parts therefor, namely internal and external pacemakers, programming and testing apparatus for pacemakers, electrodes, circulation relieving apparatus, cardiological diagnostic apparatus, analysis apparatus, patient monitoring apparatus and medical measuring and control apparatus; artificial organs, endoprostheses; all the aforesaid goods only for professional medical and clinical use. Clean rooms and sterile rooms. Biology, chemistry or biochemistry services; services of medical, bacteriological and chemical laboratories; hygiene monitoring; research, development and consultancy in the field of diagnostics, such as the development of reagents and test kits, in particular based on serology and immunogenetics; virus diagnostics; research, development and consultancy in the field of medical technology; medical research and development, in particular in the field of haematology, intensive medicine, transplant medicine, blood clotting, virus diseases (AIDS research) and anaesthesia. Medical and veterinary services, medical analysis in connection with the treatment of individuals (including X-rays and blood samples); Pharmaceutical advisory services; medical consultancy, in particular in the field of haematology, intensive medicine, transplant medicine, blood clotting, virus diseases and anaesthesia.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
20 - Furniture and decorative products
35 - Advertising and business services
42 - Scientific, technological and industrial services, research and design
Goods & Services
Chemicals used in industry and science; in-vitro diagnostic preparations for use in industry, medicine and science; in-vitro diagnostic preparations, in particular for proteins, including antibodies, microsomal antibodies or immunoglobulins, or nucleic acids for blood group diagnostics and antibody determination, tissue typing, cell diagnostics, microbiological diagnostics and hygiene control; test kits and reagents, in particular for blood group diagnostics, antibody determination, tissue typing, cell diagnostics, microbiological diagnostics, substance determination, in particular toxic substances, in particular test kits with a serological and immunogenic base, and reagents therefor; enzyme-linked immunosorbent assays (ELISAs), and reagents therefor; prepared culture media; culture media and components therefor; systems for resistance determination and pathogen identification, included in class 1; buffers, salts, solvents and reagents for the aforesaid test kits; plates and microtitre plates, in particular for cell typing, blood and virus diagnostics; DNA samples; infection diagnostic preparations. Pharmaceutical and veterinary preparations; preparations for health care; dietetic substances adapted for medical use; food for babies; plasters; materials for dressings; pharmaceutical preparations for use in haematology, intensive medicine, transplant medicine and for affecting blood-clotting; immunoglobulin preparations; serum preparations; in particular serum proteins and solutions containing serum proteins; human protein; blood products, blood substitute; plasma substitute; vaccines, in particular with immunoglobulin bases; clotting preparations, in particular clotting factors; antibiotics, narcotics, medicines for treating the central nervous system; medicines for treating cardiovascular disorders; medicines for respiratory purposes; medicines for urological treatment; medicines for treating the digestive system and adjoining glands; hormones; vitamins; immunosuppressant, anti-inflammatory, anti-allergic, hyposensitising and detoxification medicines; dermatological, ophthalmological and otological medicines; products for in-vitro diagnostics; antibodies, in particular microsomal antibodies for use in in-vitro diagnostics and therapy. Measuring, signalling, checking (supervision) and weighing apparatus and instruments; measuring and checking (supervision) apparatus for determining and quantifying microorganisms in the air, liquids and on surfaces; measuring and checking (supervision) apparatus for determining and quantifying substances, in particular blood sugar, alcohol in blood or breath, toxic substances, oxygen, and blood components, including haemoglobin; in particular apparatus for determining the quantity of germs in the air and for hygiene monitoring; diagnostic analysis apparatus. Surgical, medical, dental and veterinary apparatus and instruments; bottles and containers for storing and preserving transfusion and infusion solutions; instruments, apparatus or devices for extracting and determining microorganisms in different media; apparatus for the (micro) determination of interesting, in particular labelled substances, for diagnostic purposes; transfusion and infusion apparatus and devices; blood warmers; apparatus for the extraction and handling of cells, including disposable materials; diagnostic analysis systems. Plastic containers for holding, storing and handling blood; plastic containers for separating blood into its components; plastic containers for plasma substitutes and for infusion solutions, finished packaging of plastic for holding, separating and administering blood and blood components, including microfilter packaging. Retail services. Biology, chemistry and biochemistry; services of medical, bacteriological and chemical laboratories; hygiene monitoring; research, development and consultancy in the field of diagnostics, including the providing and development of reagents and test kits, in particular with a serological and immunogenic base; virus diagnostics; research, development and consultancy in the field of medical technology; medical research, development and consultancy, in particular in the field of haematology, intensive medicine, transplant medicine, blood-clotting, viral disorders (AIDS research) and anaesthetics; sale services.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Food preserving products. Medicines, chemical products for medical and sanitary use,
pharmaceutical drugs, plasters, surgical dressings,
pesticides and herbicides, disinfectants, particularly
preserved serum.
