Methods for modeling protein stability
AssigneeBaxter International Inc.
InventorPeter Matthiessen
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Abstract
The present invention relates to a method for determining the highest temperature that is suitable for performing accelerated protein stability studies, as well as to a method for modeling real-time protein stability from accelerated stability data generated at said temperature.
Claims27
1-6. (canceled)
A method for modeling protein stability over time, comprising the steps:
- (a) determining a stability of a protein at a plurality of temperatures within a specific temperature range;
- (b) creating an Arrhenius plot comprising the stability of the protein at the plurality of temperatures determined in step (a);
- (c) identifying a linear portion of the Arrhenius plot created in step (b);
- (d) determining an assay temperature consisting of the highest temperature within the linear portion of the Arrhenius plot created in step (b);
- (e) performing an accelerated stability study of the protein at the assay temperature determined in step (d);
- and
- (f) determining a stability of the protein at a second temperature based on the accelerated stability data obtained in step (e), wherein the second temperature is lower than the assay temperature.
(canceled)
12-17. (canceled)
The method of claim 50, wherein the predetermined level of stability is a threshold level of enzymatic activity.
The method of claim 50, wherein the predetermined level of stability is a threshold level of protein oligomerization.
The method of claim 50, wherein the predetermined level of stability is a threshold level of protein degradation.
The method of claim 50, wherein the predetermined temperature is between 2° C. and 8° C.
(canceled)
A method for determining the shelf-life of Factor VIII formulation, comprising the steps:
- (a) performing an accelerated stability study of the Factor VII formulation at a temperature equal to or less 30° C.;
- and
- (b) determining the expected shelf-life of the formulation based on the accelerated stability study.
25-28. (canceled)
A method for determining the shelf-life of an antithrombin III (AT III) formulation, comprising the steps:
- (a) performing an accelerated stability study of the AT III formulation at a temperature equal to or less 20° C.;
- and
- (b) determining the expected shelf-life of the formulation based on the accelerated stability study.
31-34. (canceled)
The method of claim 50, wherein the protein is an antibody.
37-38. (canceled)
The method of claim 50, wherein the protein is a plasma-derived protein.
(canceled)
The method of claim 50, wherein the protein is Factor VIII.
The method of claim 50, wherein the protein is antithrombin III (AT III).
43-49. (canceled)
Dependencies are inferred from the claim text.