Formulations with reduced oxidation
AssigneeGenentech, Inc.
InventorsSreedhara ALAVATTAM, Mary MALLANEY, Parbir GREWAL
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Abstract
The invention provides formulations comprising a protein in combination with a compound that prevents oxidation of the protein. The invention also provides methods for making such formulations and methods of using such formulations. The invention further provides methods of screening for compounds that prevent oxidation of a protein in a protein composition and methods of preventing oxidation of a protein in a formulation.
Claims42
A liquid formulation comprising a protein and a compound which prevents oxidation of the protein in the liquid formulation, wherein the compound is of formula:
- wherein R2 is selected from hydrogen, hydroxyl, —COOH, and —CH2COOH;
- R3 is selected from hydrogen, hydroxyl, —COOH, —CH2COOH, and —CH2CHR3a(NH2);
- wherein R3a is COOH or hydrogen;
- R4, R5, R6, and R7 are independently selected from hydrogen and hydroxyl;
- provided that one of R2, R3, R4, R5, R6, and R7 is hydroxyl;
- or a pharmaceutically acceptable salt thereof.
A method of making a protein formulation comprising adding an amount of a compound that prevents oxidation of a protein to the protein formulation, wherein the compound is of formula:
- wherein R2 is selected from hydrogen, hydroxyl, —COOH, and —CH2COOH;
- R3 is selected from hydrogen, hydroxyl, —COOH, —CH2COOH, and —CH2CHR3a(NH2);
- wherein R3a is COOH or hydrogen;
- R4, R5, R6, and R7 are independently selected from hydrogen and hydroxyl;
- provided that one of R2, R3, R4, R5, R6, and R7 is hydroxyl;
- or a pharmaceutically acceptable salt thereof.
A method of preventing oxidation of a protein in a protein formulation comprising adding an amount of a compound that prevents oxidation of the protein to the formulation, wherein the compound is of formula:
- wherein R2 is selected from hydrogen, hydroxyl, —COOH, and —CH2COOH;
- R3 is selected from hydrogen, hydroxyl, —COOH, —CH2COOH, and —CH2CHR3a(NH2);
- wherein R3a is COOH or hydrogen;
- R4, R5, R6, and R7 are independently selected from hydrogen and hydroxyl;
- provided that one of R2, R3, R4, R5, R6, and R7 is hydroxyl;
- or a pharmaceutically acceptable salt thereof.
A method of screening a compound that prevents oxidation of a protein in a protein composition, comprising selecting a compound that has lower oxidation potential and less photosensitivity as compared to L-tryptophan, and testing the effect of the selected compound on preventing oxidation of the protein.
Dependencies are inferred from the claim text.