Formulations of modified antibodies and methods of making the same
First Claim
1. A method of making a modified antibody formulation, comprising:
- a) providing a pre-lyophilized modified antibody solution comprising molecules capable of adversely affecting the stability or solubility of the modified antibody after lyophilization, and a modified antibody;
b) removing at least some of the molecules from the pre-lyophilized modified antibody solution; and
c) lyophilizing the solution from step (b), producing a lyophilized modified antibody formulation.
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Accused Products
Abstract
The present invention is directed to novel formulations of modified antibodies and to methods of producing the same. The modified antibodies formulated according to the present invention each comprise an antibody fragment covalently attached to at least one nonproteinaceous polymer, such as poly(ethyleneglycol). CDP870 is an example of one such modified antibody, a therapeutic modified antibody. One method disclosed herein involves the removal from a solution of the modified antibody of molecules capable of adversely affecting the stability or solubility of the modified antibody after lyophilization (e.g., by dialysis or diafiltration), followed by lyophilization of the modified antibody. Another method involves concentration of a modified antibody solution by equilibrium dialysis. The methods of the present invention can be used to produce formulations suitable for use in subcutaneous and parenteral injection, including high concentration formulations.
25 Citations
61 Claims
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1. A method of making a modified antibody formulation, comprising:
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a) providing a pre-lyophilized modified antibody solution comprising molecules capable of adversely affecting the stability or solubility of the modified antibody after lyophilization, and a modified antibody;
b) removing at least some of the molecules from the pre-lyophilized modified antibody solution; and
c) lyophilizing the solution from step (b), producing a lyophilized modified antibody formulation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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21. A method of making a formulation of CDP870, comprising:
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a) providing a pre-lyophilized solution comprising;
CDP870 and molecules capable of adversely affecting the stability or solubility of CDP870 after lyophilization;
b) removing at least some of the molecules from the pre-lyophilized solution; and
c) lyophilizing the solution from step (b), producing a lyophilized CDP870 formulation. - View Dependent Claims (22, 32)
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33. A method of treating or preventing a condition or disease in a mammalian subject, comprising:
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a) providing a reconstituted lyophilized formulation of CDP870 produced by, prior to lyophilization, removing molecules capable of adversely affecting the stability or solubility of CDP870 after lyophilization; and
b) administering a pharmaceutically effective amount of the reconstituted lyophilized formulation of CDP870 to the subject. - View Dependent Claims (34, 35, 36, 37, 38)
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- 39. A high concentration modified antibody formulation, comprising a modified antibody in a diluent for a modified antibody concentration of at least about 300 mg/ml.
- 54. A high concentration formulation of CDP870, comprising CDP870 in a diluent for a CDP870 concentration of at least about 300 mg/ml.
Specification