Abstract: The invention relates to an immunoglobulin composition reduced in thrombogenic agents and to methods for its preparation. One method comprises subjecting an immunoglobulin containing solution to a negative cation exchanger chromatography at a pH in the range of higher than 3.8 to equal to or lower than 5.3. The solution can also be subjected to a negative anion exchanger chromatography at a pH in the range of 7 to 8.2.

Abstract: Method for preparing a factor VIII solution that is essentially free of viruses and essentially devoid of vWF (von Willebrand factor) and factor VIII-vWF complexes by (a) obtaining a starting factor VIII solution devoid of factor VIII-vWF complexes; and (b) filtering the solution through a hydrophilic virus filter.

Abstract: The present invention comprises a method of protecting organs or tissue susceptible to reperfusion-induced dysfunction after ischemia. The method comprises parenterally administering to a patient a therapeutical composition containing natural alpha-1 acid glycoprotein, natural alpha-1 antitrypsin or a mixture thereof. Alternatively, organ or tissue transplants can be contacted with natural alpha-1 acid glycoprotein, natural alpha-antitrypsin or mixtures by perfusing or flushing them with a solution containing natural alpha-1 acid glycoprotein, natural alpha-1 antitrypsin or mixtures thereof in a concentration of 0.1 to 5 g/l.

Abstract: The invention is directed to methods of using Ig compositions to prevent and/or treat humans, livestock and/or domesticated animals suffering from stress induced respiratory disorders. The Ig composition comprises a concentrated amount of one or more immunoglobulins selected from the group consisting of alpha, beta, and gamma globulins. Preferably, the Ig composition comprises other antibodies identified as providing an immune response and/or immune factors such as complement and transfer factors. The Ig composition preferably includes immunoglobulins specific to a variety of antigens. In a preferred method, an equine Ig composition is used to treat exercise induced pulmonary hemorrhage in horses.

Abstract: Purification of &agr;-1 proteinase inhibitor (&agr;-1 PI) from aqueous solutions, such as human plasma, is accomplished by precipitation of contaminating proteins from the aqueous solution, followed by dilution of the solution to adjust its conductivity, and passing of the solution through an anion exchange resin. The conductivity of the solution is adjusted so that the &agr;-1 PI binds to the anion exchange resin, while other contaminating proteins and solvent pass through the resin. Further purification may be accomplished by cation chromatography, which takes advantage of the fact that &agr;-1 PI does not bind to the cation column under certain conditions. Some embodiments of the invention also include virus removal and/or inactivation by methods such as nanofiltration and such as contact with a non-ionic detergent. The methods of the present invention result in greater yield, purity, and pathogenic clearance of plasma fractions than known methods.

Abstract: The present invention relates generally to a method of separating one or more components from a protein mixture. More particularly, this invention is directed to a method of separating one or more components of blood plasma comprising one or more filtration steps using a cellulose-based filter aid. The present invention is useful in the preparation of therapeutics, in particular plasma-based therapeutics for use in humans.

Abstract: The invention relates to a method of removing endotoxin from preparations of alpha-1-acid glycoprotein (orosomucoid) by contact with a finely divided non-toxic resin such as fumed silica. The invention also relates to a purification process for alpha-1-acid glycoprotein which includes this deprogenation step, and to the depyrogenated product and its clinical uses.

Abstract: A process for reducing degradation of recombinant coagulation factor VIII caused by metal-dependent proteases requiring Zn.sup.2+ for activity or containing Zn.sup.2+ as an integral part of their structure comprises adding an inhibitor of Zn.sup.2+ dependent proteases to a recombinant factor VIII solution. The recombinant factor VIII solution is obtained after harvesting a conditioned medium from a cell culture used for producing the recombinant coagulation factor VIII. The inhibitor is selected from complexing agents with a stronger affinity for the Zn.sup.2+ ion of the protease than for the ion or ions stabilizing the factor VIII molecule, and compounds structurally related to the natural substrate of the protease and containing an electronegative moiety.

Abstract: The invention relates to a method of producing virus-safe highly purified factor VIII. The method includes a combination of the following measures:a) chromatographic purification of a factor VIII-containing fraction,b) tenside treatment of factor VIII in an aqueous solution at a tenside/protein ratio of from 1:1 to 1000:1, andc) heat treatment of the factor VIII preparation in the solid state.

Abstract: There is disclosed a pharmaceutical preparation based on Lys-plasminogen and available in the lyophilized form. This preparation contains a serine-protease inhibitor and optionally an inhibitor co-factor, preferably in an amount of 0.5 to 30 nmol per mg Lys-plasminogen. This preparation is free of side-effects and may be used for the treatment and prophylaxis of plasminogen deficiency syndromes and thromboses as well as for the production of thromboresistant artificial organs.

Abstract: A method of preparing an IgA rich preparation comprising exposing a plasma fraction to an amino acid, organic salt or inorganic salt with optional chromatographic treatment yielding a product suitable for use in medical conditions treatable with IgA.

Abstract: A method of and apparatus for separating proteins adsorbed by ion-exchange gels, especially anion-exchanging gels includes at least one chromatographic column in which the protein-carrying gel is charged and is subjected to a gradient-elution with a buffer solution as eluant whose property is changed with time by gradually changing the ionic strength and maintaining a substantially constant pH value or by gradually changing the pH value and maintaining substantially a constant ionic strength. The obtained eluate is then fractionated into its various components.

Abstract: A source for antibodies (both IgG and IgM types) is put into an aqueous solution which includes a virucidal agent under conditions sufficient to assure substantially complete dissolution of both the antibodies and the virucidal agent and virus inactivation. Then the pH, conductivity and antibody concentration of the solution are then changed to obtain conditions sufficient to assure the precipitation of substantially all antibodies while maintaining substantially all of the virucidal agent in the supernatant solution.In preferred embodiments, using a TNBP/TWEEN virucidal agent, the original solution conductivity ranges from about 0.03 to 0.20 M MHO/CM, the pH ranges from about 4.75 to 4.85, and the protein concentration, when measured at A280, ranges from a reading of about 5 to 40. In the second precipitation step, the pH is changed to a range of about 6.0 to 7.5 and the conductivity is changed to a range of about 0.05 to 0.

Abstract: In order to avoid the risk of undesired side reactions of blood products, the latter are produced from plasma by using chymotrypsin to inactivate prekallikrein activator. These preparations are obtained by the fractionated enrichment of plasma proteins, with the proviso that a chymotrypsin solution or immobilized chymotrypsin is added to the fractions at any stage of the fractionation process. Before completion of the preparations, the chymotrypsin or the immobilized trypsin is removed from the preparations.

Abstract: A process for the production of a preparation of blood coagulation factor VIII which makes it possible to obtain a pasteurized product which is virtually free of immunoglobulins, isoagglutinins, fibronectin and coagulable fibrinogen is described.A product of this type can be used for the treatment of blood coagulation disturbances.

Abstract: A method of sterilizing plasma or plasma fractions, including fractions that contain the blood-coagulating Factor VIII by treatment with .beta.-propiolactone or ultraviolet radiation. Treatment with tri-n-butyl phosphate and sodium cholate or Tween 80 is carried out either prior to or simultaneously with the .beta.-propiolactone treatment or ultraviolet radiation.

Abstract: Human conglutinin, polyclonal, and monoclonal antibodies raised against human conglutinin, and their uses in therapy and diagnosis are described.Human conglutinin was obtained from human plasma by affinity chromatography with anti-bovine conglutinin antibody, has a relative molecular weight of 330 and 40 K unreduced and 66 K reduced as measured by SDS-PAGE, shows calcium-dependent and sugar inhibitable binding to complement-reacted immune complexes and zymosan, and immunological cross-reaction with anti-bovine conglutinin antibody.

Abstract: The administration of Factor I and/or Factor H to a mammal has been found to alleviate or prevent such autoimmune diseases as systemic lupus erythematosus, rheumatoid arthritis and glomerulonephritis.

Abstract: An improved process for the preparation of gamma globulin suitable for intravenous administration comprises dissolving gamma globulin precipitated from blood or blood products in a solution, separating non-dissolved precipitate from the solution, adding polyethylene glycol to the separated solution, separating precipitate from the polyethylene glycol solution, increasing the polyethylene glycol concentration in the solution, separating precipitated purified gamma globulin from the higher concentrated polyethylene glycol solution, dissolving the purified gamma globulin in a solution suitable for intravenous administration, which process is improved by dissolving the gamma globulin precipitated from blood in a solution having a neutral pH, adding polyethylene glycol in the first step to a concentration of 4.0-5.

Abstract: High purity albumin can be recovered in high yield from human plasma protein solution containing albumin by heat-treatment of the solution to denature and precipitate non-albumin proteins in a combination of specific conditions such as protein concentration of the solution, pH, heating time and temperature, the concentration of precipitant ammonium sulfate.

Abstract: A method for maintaining intact, non-degraded von Willebrand factor by preventing the action of calcium activated protease(s) responsible for degradation of the factor. The action of the calcium activated protease(s) may be avoided by removing the blood platelet source of the protease(s), by filtering or centrifugal separation, or by inactivating the protease with a chelating agent removing the calcium, by a protease inhibitor, or an alkylating agent.

Abstract: There is disclosed a method for separating alpha-1-proteinase inhibitor (also known as alpha-1 antitrypsin) from an aqueous solution of plasma proteins, especially from Cohn Effluent II & III and Cohn Effluent I. The method includes the steps of first treating the aqueous solution to lower the concentration of salts therein and, optionally, its alcohol content, contacting the resulting solution with an anion exchange resin having selective affinity for alpha-1-proteinase inhibitor to selectively bind the alpha-1-proteinase inhibitor and allow unwanted plasma proteins to elute through the resin, displacing the alpha-1-proteinase inhibitor from the resin and recovering the same.

Abstract: Normal plasma from donors who have not been vaccinated with a Pseudomonas vaccine or had a Pseudomonas infection can be screened for higher than normal titers of naturally occurring antibody to four of seven Fisher Immunotypes for Pseudomonas. Those plasmas with higher titers of such antibody can be pooled and fractionated to give hyperimmune serum globulin having high titers of antibody against all seven Fisher Immunotypes. The product may be treated to render it intravenously injectable and the so-prepared material is effective in treating patients with Pseudomonas infection.