Formulations of single domain antigen binding molecules
AssigneeAblynx N.V.
InventorsJason E. Fernandez, Daniel A. Dixon, Andrea Paulson
Life of this patent
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Abstract
The invention relates to formulations of single domain antigen binding molecules, e.g., nanobody molecules, in particular formulations of TNF-binding nanobody molecules. The single domain antigen binding molecules can include one or more single binding domains that interact with, e.g., bind to, one or more target proteins. The formulations are useful, e.g., as pharmaceutical formulations. Method of preparing, and using the formulations described herein, to treat, e.g., TNF-associated disorders, are also disclosed.
Claims14
-23. (canceled)
A method of treating or preventing a disorder, comprising administering to a subject a pharmaceutical composition that comprises:
- (a) a therapeutic agent at a concentration of 0.1 mg/mL to about 350 mg/mL;
- (b) a lyoprotectant;
- and (c) a buffer at a concentration of about 5 to about 50 mM, such that the pH of the pharmaceutical composition is about 5.0 to 7.5.
A method of analyzing a manufacturing process, comprising:
- providing a sample formulation;
- assessing a parameter of the sample formulation chosen from color, clarity, viscosity, or an amount of one or more HMW, LMW, acidic or basic species;
- and
- determining whether the parameter meets a preselected criteria, thereby analyzing the process;
- wherein the sample formulation comprises:
- (a) a therapeutic agent at a concentration of 0.1 mg/mL to about 350 mg/mL;
- (b) a lyoprotectant;
- and (c) a buffer at a concentration of about 5 to about 50 mM, such that the pH of the formulation is about 5.0 to 7.5.
A formulation comprising:
- (a) a therapeutic agent at a concentration of about 0.1 mg/mL to about 350 mg/mL;
- (b) a lyoprotectant;
- and (c) a buffer at a concentration of about 5 to about 50 mM, such that the pH of the formulation is about 5.0 to 7.5.
Dependencies are inferred from the claim text.