Back to results
US 10,377,793 B2Granted
Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
AssigneeHoffmann-La Roche Inc.
InventorSebastian Neumann
Life of this patent
Estimating the term…
Abstract
Herein is reported a method for producing a polypeptide in monomeric form comprising the following step: recovering the polypeptide in monomeric form from an ion exchange chromatography material by applying a solution comprising a non-ionic polymer and an additive.
Claims12
A method for producing an antibody of the IgG class in monomeric form comprising the following steps:
- applying a first solution that optionally comprises poly (ethylene glycol) and glycine to a cation exchange chromatographic material thereby equilibrating the material,
- applying a solution comprising the antibody of the IgG class to the equilibrated cation exchange chromatography material thereby loading the chromatography material, and
- applying a solution comprising poly (ethylene glycol) having a concentration of about 10% by weight and glycine having a concentration of about 4% to 8% by weight to the cation exchange chromatography material, thereby separating the antibody of the IgG class in monomeric form from the antibody in aggregate form and obtaining the antibody in monomeric form.
A method for producing an antibody of the IgG class preparation with reduced host cell protein content comprising the following steps:
- applying a first solution that optionally comprises poly (ethylene glycol) and glycine to a cation exchange chromatographic material thereby equilibrating the material,
- applying a solution comprising the antibody of the IgG class to the equilibrated cation exchange chromatography material thereby loading the chromatography material, and
- applying a solution comprising poly (ethylene glycol) having a concentration of about 10% by weight and glycine having a concentration of about 4% to 8% by weight to the cation exchange chromatography material, thereby separating the antibody of the IgG class in monomeric form with reduced host cell protein content from the antibody in aggregate form and obtaining the antibody in monomeric form with reduced host cell protein content.
Dependencies are inferred from the claim text.