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US 2015/0308988 A1Published application
Antibody Coformulations
AssigneeXoma Technology Ltd.
InventorsSusan Joyce Babuka, Chin-Yi Huang, Mingxiang Li
Life of this patent
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Abstract
This invention relates to stable formulations of multiple antibodies comprising a plurality of antibodies and an effective amount of a succinate buffer wherein the pH of the formulation is between about 4.5 and about 7.0.
Claims30
A method of determining if an antibody co-formulation comprising three or more antibodies will be stable for at least 30 days, the method comprising:
- (a) detecting deamidation products and stable deamidation intermediates of an antibody in the co-formulation to provide a deamination profile;
- (b) detecting an aggregate profile and/or a size-based degradation rate of an antibody to provide an aggregate profile and/or a degradation profile of the antibody;
- (c) comparing detected results of step (a) and (b) of each antibody in the co-formulation to a reference deamination profile and aggregate and/or degradation profile of the antibodies;
- wherein a significant difference between the deamination profile and aggregate and/or degradation profile and the reference deamination profile and aggregate and/or degradation profile of one or more antibodies indicates that the antibody co-formulation will not be stable for at least 30 days.
1 more element
A method of determining if an antibody co-formulation comprising three or more antibodies will be stable for at least 30 days, the method comprising:
- (a) detecting the thermal transition temperature (TTT) of each of the three or more antibodies in the co-formulation;
- (b) comparing the TTT detected for each of the three or more antibodies of step (a) to a respective reference thermal transition temperature for each of the three or more antibodies;
- wherein a significant difference between the TTT and the reference TTT for one or more antibodies indicates that the antibody co-formulation will not be stable for at least 30 days.
Dependencies are inferred from the claim text.