Composition comprising antibody that binds to domain ii of her2 and acidic variants thereof
AssigneeGenentech, Inc.
InventorsReed J. HARRIS, Paul A. MOTCHNIK
Life of this patent
Estimating the term…
Abstract
A composition comprising a main species HER2 antibody that binds to domain II of HER2and acidic variants thereof is described. Pharmaceutical formulations comprising the composition, and therapeutic uses for the composition are also disclosed.
Claims20
A composition comprising a main species HER2 antibody that binds to domain II of HER2, and acidic variants thereof wherein the acidic variants include glycated variant, disulfide reduced variant, or non-reducible variant.
A method of treating HER2 positive cancer in a patient comprising administering a pharmaceutical formulation comprising a main species HER2 antibody that binds to domain II of HER2, and acidic variants thereof wherein the acidic variants include glycated variant, disulfide reduced variant, or non-reducible variant in a pharmaceutically acceptable carrier to the patient in an amount effective to treat the cancer.
A method of making a pharmaceutical composition comprising:
- (1) preparing a composition comprising a main species HER2 antibody that binds to domain II of HER2, and acidic variants thereof including glycated variant, disulfide reduced variant, or non-reducible variant, and (2) evaluating the acidic variants in the composition, and confirming that the amount thereof is less than about 25%.
Dependencies are inferred from the claim text.