Grifols, S.a.

Grupo Grifols, S.a.

Probitas Pharma S.a.

Instituto Grifols, S.a.

Pere Ristol Debart

Juan Ignacio Jorquera Nieto

Montserrat Costa Rierola

Salvador Grancha Gamon

Maria Mercedes Faro Tomas

Jesus Fernandez Rodriguez

Francisco Rabaneda Gimenez

Ma Teresa Lopez Hernandez

Isabel Bravo Camison

David Camarero Torrecillas

Nuria Jorba Grifols

Rafael Lopez Gomez

Marta Massot Riera

Isabel Brava Camison

The present invention relates to a method for the preparation of a solution of immunoglobulins based on an initial solution of immunoglobulins with a purity greater than or equal to 96% in the presence of a polyether or polymer of glycol, characterized in that it comprises the steps of: a) adding caprylic acid or salts of the same to the initial solution; b) adjusting the pH of the solution obtained in step a); c) incubating the solution obtained in step b) for the time and at a temperature necessary for the inactivation of enveloped viruses; d) performing a step of ultrafiltration/diafiltration on the solution obtained in step c).

Method for the preparation of immunoglobulins

The stable thrombin composition comprises purified thrombin, human albumin and a neutral salt, the resulting product being stable when stored as a lyophilisate or frozen and is adjusted to a nominal strength of 500 IU of thrombin or more per ml of solution, the human albumin being in a concentration of over 0.05% (w/v) and preferably between 0.1% (w/v) and 1% (w/v).

Process to prepare a stable thrombin composition

A process for obtaining an IgG composition involves heat treatment. This process obtains an IgG composition from an IgG solution partly purified from human plasma, in which by applying intermediate heat treatment and without using reagents to precipitate high molecular weight aggregates/polymers and/or proteins virtually total elimination of the IgG polymers generated during the process is achieved. Furthermore this process offers high productivity, lower production costs and is easy to implement in comparison with the processes of the know art. In addition to this, by using this process stability is imparted to the final product in liquid.

Process for obtaining an IgG composition through heat treatment

A concentrate of Von Willebrand Factor (VWF) or a complex of Factor VIII/VWF is prepared by creating a solution of VWF or a complex of Factor VIII/VWF containing VWF at a concentration of up to 12 IU VWF:RCo/ml and a VWF/Factor VIII ratio of 0.4 or more; and nanofiltering that starting solution through a filter of pore size of 35 nanometers or smaller. The resulting VWF retains high molecular weight multimers.

Process for obtaining a concentrate of Von Willebrand factor or a complex of factor VII/Von Willebrand factor and use of the same

A process for detoxifying the blood of a patient in need thereof involves: collecting albumin from human plasma and/or plasma fractions; diafiltration of a mixture containing the collected albumin; stabilizing the resulting diafiltered albumin mixture with sodium chloride and an amino acid in the absence of any added fatty acid; pasteurizing the stabilized albumin mixture; diafiltering the pasteurized mixture to remove, among other things, stabilizers; and detoxifying the blood of the patient by administering the resulting albumin to the patient. In one embodiment, the amino acid stabilizing agent is acetyl tryptophan. The resulting albumin has at least about 80% albumin binding capacity relative to natural plasma albumin, and is storage stable for about 30 months at 30&#xb0; C.

Process for obtaining high efficiency human albumin for use in detoxification therapy

A process for purifying and collecting albumin from plasma and plasma fractions involves diafiltration of an albumin-containing plasma fraction; stabilizing the resulting albumin fraction with sodium chloride and an amino acid in the absence of any added fatty acid; pasteurizing the stabilized albumin fraction; and diafiltering the pasteurized fraction to remove, along other things, stabilizers. In one embodiment, the amino acid stabilizing agent is acetyl tryptophan. The resulting albumin has at least about 80% albumin binding capacity relative to natural plasma albumin, and is storage stable for about 30 months at 30&#xb0; C.

The therapeutic preparation of FVIIa having a purity of at least 1000 IU/mg of protein is characterized in that said preparation is free of proteins of non-human origin. In the method for obtaining FVII, purification starts from FrII+III, FrIII or equivalent of Cohn fractioning and comprises precipitation with PEG, chromatography and its subsequent activation.

Therapeutic preparation of very high purity FVIIa and method for obtaining same

A process for removing viruses in fibrinogen solutions and fibrinogen obtained thereof wherein the process starts with an adjusted purified fibrinogen solution, the adjusted purified solution is frozen and then thawed at a temperature between 5 and 20&#xb0; C., the undissolved materials associated with the fibrinogen are subsequently separated, the temperature is adjusted and the resultant solution is finally subjected to nanofiltration using filters having a pore size smaller than 35 nm.

Process for removing viruses in fibrinogen solutions and fibrinogen obtained by said process

The gammaglobulin is extracted from a fraction isolated by fractionation with ethanol in the presence of a carbohydrate, and after reducing the content of contaminants with PEG, it is applied to an anionic resin exchange column, an effluent being obtained in which the PEG content is subsequently reduced by ultrafiltration and which is concentrated in order to carry out sequentially an optional treatment at an acid pH and at least one of the following steps of viral inactivation, consisting of pasteurisation and a treatment with solvent/detergent, the product afterwards being precipitated and washed with PEG in order to eliminate any chemical viral inactivation reagents and then, by solubilisation and change of pH, the protein contaminants, and finally purified by ultrafiltration to reduce the volume and the PEG content, then carrying out an optional virus filtration and subsequent concentration.

Process for the production of virus-inactivated human gammaglobulin G

An efficient industrial method, by incubation at extreme (alkaline) pH in a stabilized medium, of inactivating viruses in general (with or without a lipid envelope) in media containing proteins for therapeutic use, without denaturing or significant loss of biological activity.

Method of inactivating viruses in proteins

There is described a therapeutic human albumin having a very low capacity for the absorption of aluminium, during storage in a glass receptacle, wherein the final composition of the albumin solution adjusted to be stable and isotonic at a concentration of 5, 20 or 25% of protein in an aqueous medium, preferably, or to any other therapeutic concentration acceptable for intravenous administration, has a citrate content in the final albumin composition equal to or less than 0.5 mM (millimolar) and, preferably, less than 0.037 mM (millimolar).

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Sabadell, Spain

Pere Ristol Debart