High concentration antibody formulations
AssigneeAlexion Pharmaceuticals, Inc.
InventorsXiao-Hong Zhou, Yi Wang
Life of this patent
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Abstract
The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.
Claims35
An aqueous solution comprising an anti-C5 antibody at a concentration of 40 mg/mL to 200 mg/mL, inclusive.
An aqueous solution comprising an anti-C5 antibody at a concentration of greater than 200 mg/mL.
A method for producing a concentrated antibody solution comprising greater than 100 mg/mL of an anti-C5 antibody, the method comprising:
- i) providing a first aqueous solution comprising an anti-C5 antibody, the first aqueous solution having a first formulation and comprising no more than 50 mg/mL of the anti-C5 antibody;
- ii) subjecting the first aqueous solution to diafiltration to thereby produce a second aqueous solution, wherein the second aqueous solution has a second formulation as a result of the diafiltration;
- and
- iii) concentrating the second aqueous solution to produce a concentrated antibody solution comprising greater than 100 mg/mL of the anti-C5 antibody.
Dependencies are inferred from the claim text.