Preparing and use of Glu-plasminogen from blood fractions
AssigneePrevipharma Consulting GmbH
InventorsRicarda Welz, Hanne Rieke Gerding, Marc Mazur, Stephan T. Kiessig, Hermann E. Karges
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Abstract
The present invention relates to a method for isolating Glu-plasminogen, said method comprising the anion exchange chromatography of blood plasma or a plasma fraction comprising Glu-plasminogen. Furthermore, the present invention relates to Glu-plasminogen obtainable from the method of the present invention and its use in a method for treating a patient suffering from or being at risk of developing a disorder selected from the group consisting of organ failure, a thrombotic event, arterial obstructive disease, microcirculation, disseminated intravascular coagulation (DIC), and a combination of two or more thereof.
Claims9
A method for isolating Glu-plasminogen, the method comprising the following steps:
- (i) providing a plasma fraction comprising Glu-plasminogen, wherein the plasma fraction is selected from the group consisting of:
- (a) cryo-poor plasma;
- and
- (b) fractions I+III of the Cohn or Kistler-Nitschmann process, fractions I+II+III of the Cohn or Kistler-Nitschmann process, or a combination thereof, wherein, optionally, octanoic acid is added to the fractions I+III or the fractions I+II+III;
- (ii) contacting the plasma fraction with an anion exchanger based on a resin comprising cationic groups;
- (iii) washing the anion exchanger obtained from step (ii) loaded with the plasma fraction with a first buffer B1 having a pH of 8.5 to 11 not comprising cations competing with the cationic groups of the resin of the anion exchanger;
- (iv) eluting the Glu-plasminogen from the washed anion exchanger of step (iii) with a second buffer B2 having a pH of 8.5 to 11 comprising cations competing with the cationic groups of the resin of the anion exchanger, thereby obtaining a solution comprising the second buffer B2 and Glu-plasminogen;
- (v) adjusting the pH of the solution obtained from step (iv) to a pH in a desired range of pH 4.5 to 6.5;
- (vi) stabilizing the Glu-plasminogen by adding one or more stabilizers that prevent the Glu-plasminogen from maturing into plasmin and Lys-plasminogen to the solution obtained from step (iv) and/or step (v);
- (vii) optionally subjecting the solution from any of steps (iv) to (vi) to one or more antiviral treatments;
- and
- (viii) optionally drying or freeze-drying the solutions comprising Glu-plasminogen obtained from any of steps (iv) or (vii).
Dependencies are inferred from the claim text.