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US 12,742,003 B2Granted
Multistep final filtration
AssigneeHoffmann-La Roche Inc.
InventorsRoberto Falkenstein, Klaus Schwendner
Life of this patent
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Abstract
Herein is reported a method for the final filtration of concentrated polypeptide solutions comprising the combination of two immediately consecutive filtration steps with a first filter of 3.0 μm and 0.8 μm pore size and a second filter of 0.45 μm and 0.22 μm pore size.
Claims9
A method for producing a filtered immunoglobulin solution comprising
- a) providing an immunoglobulin solution with a concentration of at least 100 g/l, and
- b) applying the immunoglobulin solution to a combination of a first and second filter unit, whereby the first filter unit comprises a pre-filter with a pore size of 3.0 μm and a main-filter with a pore size of 0.8 μm and the second filter unit comprises a pre-filter with a pore size of 0.45 μm and a main-filter with a pore size of 0.22 μm with a pressure of from 0.1 to 4.0 bar, and thereby producing the filtered immunoglobulin solution;
- wherein the immunoglobulin is an anti-HER2 antibody.
A method for producing an immunoglobulin comprising the following steps
- a) cultivating a cell, comprising a nucleic acid encoding the immunoglobulin,
- b) recovering the immunoglobulin from the cell or the cultivation medium,
- c) purifying the immunoglobulin with one or more chromatography steps, and providing an immunoglobulin solution,
- d) optionally adding a sugar, an amino acid and/or a detergent to the solution,
- e) concentrating the immunoglobulin solution to a concentration of 100 g/l or more with a method selected from diafiltration or tangential-flow filtration, and
- f) applying the immunoglobulin solution of the previous step to a combination of a first and second filter unit, whereby the first filter unit comprises a pre-filter with a pore size of 3.0 μm and a main-filter with a pore size of 0.8 μm and the second filter unit comprises a pre-filter with a pore size of 0.45 μm and a main-filter with a pore size of 0.22 μm with a pressure of from 0.1 to 4.0 bar, and thereby producing an immunoglobulin, wherein the immunoglobulin is an anti-HER2 antibody.
3 more elements
Dependencies are inferred from the claim text.