Bispecific Molecule Stabilizing Composition
AssigneeAmgen Inc.
InventorsWei Qi, Cindy Ren
Life of this patent
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Abstract
The present invention provides provide a pharmaceutical composition comprising a bispecific antigen binding molecule at an increased concentration, wherein the composition comprises at least one buffer agent, at least one saccharide; and at least one stabilizing agent selected from Ethylenediaminetetraacetic acid (EDTA), Diethylenetriaminepentetic acid (DTP A), and citric acid in order to stabilize the bispecific antigen-binding agent even at higher concentration.
Claims30
A pharmaceutical composition which is preferably liquid comprising
- (a) a bispecific antigen-binding molecule comprising at least three domains, wherein:
- a first domain binds to a target cell surface antigen, wherein the target cell surface antigen is a tumor antigen;
- a second domain binds to an extracellular epitope of the human and/or the Macaca CD3 chain;
- and
- a third domain comprises two polypeptide monomers, each comprising a hinge, a CH2 domain and a CH3 domain, wherein said two polypeptide monomers are fused to each other via a peptide linker, and wherein said third domain comprises in an amino to carboxyl order:
- hinge-CH2-CH3-linker-hinge-CH2-CH3;
- wherein the concentration of the bispecific antigen-binding molecule is 8 to 35 mg/ml;
- (b) at least one buffer agent;
- (c) at least one saccharide;
- and
- (d) at least one stabilizing agent selected from Ethylenediaminetetraacetic acid (EDTA), Diethylenetriaminepentetic acid (DTPA), and citric acid, wherein the stabilizing agent is present in a concentration in the range of 0.005% to 0.25% (w/v), preferably 0.01 to 0.2% (w/v);
- and wherein the pH of the pharmaceutical composition is in the range of 4.0 to 6.0.
A solid pharmaceutical composition, obtainable by lyophilization of the liquid pharmaceutical composition of any one of the preceding claims.
The pharmaceutical composition of any one of the preceding claims for use in the treatment of a disease, preferably of a proliferative disease.
Dependencies are inferred from the claim text.