Process for Producing a Plasma Protein-Containing Medicament
AssigneeBaxter Innovations GmbH
InventorsWolfgang Teschner, Yendra Linnau, Sonja Svatos, Herwig Igel
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Abstract
There is disclosed a method of preparing a plasma protein-containing medicament from citrated plasma or from a citrate-containing plasma fraction, the medicament being substantially free from undesired metals, which method comprises the following steps exchanging the citrate and optionally citrate-bound metals in a plasma-protein-containing solution for a water-soluble mono- or dicarboxylate or for an organic mono- or dicarboxylic acid under non-precipitating conditions, recovering the plasma protein or the plasma proteins, and finishing the medicament.
Claims15
1-13. (canceled)
A plasma-protein-containing medicament obtained from citrated plasma or from a citrate-containing plasma fraction, wherein the medicament has a reduced concentration of undesired metals selected from the group consisting of aluminum, cadmium, zinc, lead and iron, wherein the medicament is obtained by a method comprising the steps of:
- (a) obtaining citrated plasma or citrate-containing plasma fraction by Cohn fractionation;
- (b) adding to the citrated plasma or citrate-containing plasma fraction a compound to achieve a solution having a compound concentration of between 0.001 and 1.00 mol/liter, wherein the compound is selected from the group consisting of a monocarboxylate, a dicarboxylate, a monocarboxylic acid and a dicarboxylic acid;
- (c) exchanging citrate and citrate-bound metals that may be present in the plasma or plasma fraction with the compound by diafiltration, ultrafiltration or chromatography at a temperature above 0° C. to 50° C. and at a pH of 6 to 8, under non-precipitating conditions, thereby reducing the concentration of citrate and the undesired metals that may have been present;
- (d) recovering one or more plasma proteins;
- and
- (e) finishing the medicament.
A plasma-protein-containing medicament obtained from a Cohn fraction comprising plasma proteins and citrate, wherein the medicament has a reduced concentration of undesired metals selected from the group consisting of aluminum, cadmium, zinc, lead and iron, wherein the medicament is obtained by a method comprising the steps of:
- (a) adding to the Cohn fraction, a compound to achieve a solution having the compound concentration of between 0.001 and 1.00 mol/liter, wherein the compound is selected from the group consisting of a monocarboxylate, a dicarboxylate, a monocarboxylic acid and a dicarboxylic acid;
- (b) exchanging the citrate and citrate-bound metals that may be present in the Cohn fraction with the compound by diafiltration, ultrafiltration or chromatography at a temperature above 0° C. to 50° C. and at a pH of 6 to 8, under non-precipitating conditions, thereby reducing the concentration of citrate and undesired metals that may have been present;
- (c) recovering one or more plasma proteins;
- and
- (d) finishing the medicament.
The plasma-protein-containing medicament as set forth in claim wherein the medicament has a content of undesired metals of less than 200 ng/l.
Dependencies are inferred from the claim text.