Stabilized formulations containing anti-pcsk9 antibodies
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsScott M. WALSH, Daniel B. DIX
Life of this patent
Estimating the term…
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.
Claims8
1-30. (canceled)
A method for preparing a composition that comprises an 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 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 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 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 at a rate of about 0.5° C.;
- then
- k) holding at about 250 for about 60 minutes, prior to storage.
37-52. (canceled)
Dependencies are inferred from the claim text.