Stabilized formulations containing anti-PCSK9 antibodies
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsScott M. Walsh, Daniel B. Dix
Life of this patent
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Abstract
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human proprotein convertase subtilisin/kexin type 9 (PCSK9). The formulations may contain, in addition to an anti-PCSK9 antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.
Claims7
A method for preparing a composition that comprises an antibody that binds to human proprotein convertase subtilisin/kexin type 9 (anti-PCSK9 antibody) and less than 0.3% water, the method comprising the steps of:
- a) in a glass vial combining water, an anti-PCSK9 antibody, histidine, sucrose, and polysorbate 20;
- b) holding the combination of step (a) at about 5° C. for about 60 minutes;
- then
- c) decreasing the temperature to −45° C. at a rate of about 0.5° C. per minute;
- then
- d) holding at about −45° C. for about 120 minutes;
- then
- e) reducing the atmosphere pressure to about 100 mTorr;
- f) increasing the temperature to −25° C. at a rate of about 0.5° C. per minute;
- then
- g) holding at about −25° C. for about 78 hours;
- then
- h) increasing the temperature to 35° C. at a rate of 0.2° C. per minute;
- then
- i) holding at about 35° C. for about 6 hours;
- then
- j) decreasing the temperature to 25° C. at a rate of about 0.5° C. per minute;
- then
- k) holding at about 25° C. for about 60 minutes, prior to storage
- wherein the anti-PCSK9 antibody comprises an HCDR1 of SEQ ID NO:2, an HCDR2 of SEQ ID NO:3, an HCDR3 of SEQ ID NO:4, an LCDR1 of SEQ ID NO:
- 6, an LCDR2 of the amino acid sequence WAS, and an LCDR3 of SEQ ID NO:8.
Dependencies are inferred from the claim text.