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US 9,283,260 B2Granted
Lyophilized therapeutic peptibody formulations
AssigneeAmgen Inc.
InventorsWilliam J. Callahan, Richard L. Remmele, Jr., Gayathri Ratnaswamy, Ramil F. Latypov, Dingjiang Liu
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Abstract
The present invention provides long-term stable formulations of a lyophilized therapeutic peptibody and methods for making a lyophilized composition comprising a therapeutic peptibody.
Claims8
A stable lyophilized therapeutic peptibody composition comprising a buffer, a bulking agent, a stabilizing agent, and a surfactant wherein;
- said buffer is 10 mM histidine;
- the pH is 5.0;
- said bulking agent is 4% w/v mannitol;
- said stabilizing agent is 2% w/v sucrose;
- said surfactant is 0.004% w/v polysorbate-20;
- and
- said therapeutic peptibody is a dimer that comprises a structure of the formula
- F1-(L1)e-P1(L2)f-P2
- wherein:
- F1 is an Fc domain, wherein the Fc domain is attached at the N-terminus of -L1-P1-L2-P2;
- P1 and P2 are each independently selected from Table 6;
- L1 and L2 are each independently linkers;
- and
- e and f are each independently 0 or 1.
11 more elements
Dependencies are inferred from the claim text.