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.
Claims29
A method for stabilizing a polypeptide from degradation upon exposure to urea comprising performing said exposure in the presence of an amine containing solution.
A method of preparing a polypeptide comprising treating a composition comprising the polypeptide and one or more viral contaminants with urea to inactivate the viral contaminant(s), wherein said treatment is performed in the presence of a cyanate scavenger.
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 the presence of 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.
A composition comprising an antibody, urea and a cyanate scavenger.
Dependencies are inferred from the claim text.