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US 2010/0249384 A1Published application
Immunoglobulin aggregates
OwnerStefan Hepbildikler, Wolfgang Kuhne +2inventors
InventorsStefan Hepbildikler, Wolfgang Kuhne, Eva Rosenberg, Gerhard Winter
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Abstract
The current invention reports a method for concentrating an immunoglobulin solution by tangential flow filtration wherein the immunoglobulin in polymeric form can be removed after the concentration.
Claims8
A method for removing immunoglobulin aggregates from an immunoglobulin solution, comprising:
- i) providing a solution containing said immunoglobulin, wherein said immunoglobulin is present in said solution in monomeric and polymeric form, or
- providing a solution containing an immunoglobulin, wherein in said solution the formation of said immunoglobulin in polymeric form is induced by the application of heat,
- ii) concentrating said solution provided under i) by employing a tangential flow filtration with a constant Δp of 3.0 bar, and a constant transmembrane pressure of 0.6 bar;
- and
- iii) removing immunoglobulin aggregates from the immunoglobulin solution obtained in step ii) by filtration with a 0.2 μm pore size filter,
- whereby the number of particles in said concentrated solution of step ii) with a size of more than 1 μm is smaller than 200 times the number of particles with a size of more than 1 μm in the solution prior to the concentrating when determining the number of particles by light obscuration.
3 more elements
Dependencies are inferred from the claim text.