Stabilizing polypeptides which have been exposed to urea
AssigneeGenentech, Inc.
InventorsJefferson C. Emery, Paul J. McDonald, Rhona M. O'Leary
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Abstract
Methods for stabilizing polypeptides, such as anti-HER2 antibodies, which have been exposed to urea.
Claims22
A method for stabilizing an antibody from degradation upon exposure to urea comprising determining that said antibody shows degradation upon exposure to urea, exposing said antibody to urea in the presence of an amine containing solution comprising an amino acid, and confirming that degradation of said antibody has been prevented or reduced.
A method of preparing a monoclonal antibody comprising treating a composition comprising the monoclonal antibody and one or more viral contaminants with urea to inactivate the viral contaminant(s), wherein said treatment is performed in the presence of an amine-containing solution comprising an amino acid as a cyanate scavenger.
A method of inactivating or reducing viral contamination in a composition comprising an anti-HER2 antibody and one or more viral contaminant(s) comprising treating the composition with urea, in the presence of an amine-containing solution comprising an amino acid as a cyanate scavenger.
An isolated composition comprising an anti-HER2 antibody, and urea and an amino acid added to said antibody, wherein the concentration of said antibody in the composition is from about 1 mg/mL to about 10 mg/mL.
An isolated composition comprising a anti-HER2 antibody, and urea ad a amino acid added to said antibody, wherein the concentration of said urea in the composition is from about 2M to about 4M.
An isolated composition comprising an anti-HER2 antibody, and urea and an amino acid added to said antibody, wherein the concentration of the amino acid is from about 200 mM to about 400 mM.
A method of preparing a polypeptide comprising:
- (a) purifying the polypeptide by a first purification step;
- and
- (b) treating the polypeptide of step (a) with urea to inactivate viral contamination thereof,
- wherein said treatment is performed in to presence of a amine-containing solution comprising an amino acid as a cyanate scavenger.
Dependencies are inferred from the claim text.