Grifols, S.a.

Instituto Grifols, S.a.

Juan Ignacio Jorquera Nieto

Pere Ristol Debart

Montserrat Costa Rierola

Maria Mercedes Faro Tomas

Olga Santaeularia Lozano

Nuria Hosta Mateu

Salvador Grancha Gamon

Jesus Fernandez Rodriguez

Isabel Bravo Camison

Rafael Lopez Gomez

Ana Maria Ortiz Fernandez

Jose Maria Diez Cervantes

José María Diez Cervantes

Nuria Jorba Grifols

Marta Massot Riera

Isabel Brava Camison

Ana Maria Ortiz Fernández

José Maria Diez Cervantes

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

A method prepares a solution of human albumin by reducing dissolved oxygen in a solution of albumin until a concentration of oxygen equal to or less than 0.5 ppm is achieved. A solution of human albumin having a redox state closer to the redox state of the albumin present in human plasma can be achieved.

Method for the preparation of human albumin with reduced level of dissolved oxygen

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 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

The present invention relates to mammalian cell culture media which comprise supernatant from some of the fractions of human plasma fractionation according to the Cohn method, more specifically, the supernatant of fractions I and II+III. When said supernatant is added as a culture medium supplement it provides various nutrients and factors for the effective maintenance and/or proliferation of the cultured mammalian cells. In addition, the present invention relates to the preparation process and use of said medium in the culture of mammalian cells.

Mammalian cell culture media which comprise supernatant from cohn fractionation stages and use thereof

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 invention discloses a purified albumin solution of human origin with low prekallicrein activator (PKA) activity and stability over time characterized in that it has an antithrombin content equal to or greater than 0.03 mg/g of albumin, and a process for production thereof by the partial extraction of the antithrombin during fractionation of the human plasma.

Therapeutic human albumin solutions with low prekallikrein activator (PKA) activity and process for obtaining them

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

The invention discloses a purified albumin solution of human origin with low prekallicrein activator (PKA) activity and stability over time characterised in that it has an antithrombin content equal to or greater than 0.03 mg/g of albumin, and a process for production thereof by the partial extraction of the antithrombin during fractionation of the human plasma.

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Ametlla del Valles, Spain

Juan Ignacio Jorquera Nieto