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US 2024/0392009 A1Published application
Pharmaceutical compositions for antibodies and making and using the same
AssigneeInvetx, Inc.
InventorsKrishnan Sampathkumar, Chi-Ting Huang
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Abstract
A stable pharmaceutical formulation comprising: an antibody comprising a polypeptide having a canine CH2, CH3, IgG Fc region variant, or a canine FcRn-binding region thereof; a buffering agent at a pH in the range of from 4.5 to 7.0; a tonicity and/or stabilizing agent; a chelating agent; and a surfactant; wherein the formulation retains stability for up to twenty-four months in solution and is suitable for oral, rectal, transmucosal, intestinal, or parenteral administration.
Claims20
A stable pharmaceutical formulation comprising:
- (a) 5 to 100 mg/ml of an antibody comprising a polypeptide having a canine or feline CDR of variable antibody domain, CH2, CH3, IgG Fc region variant, or a canine or feline FcRn-binding region thereof;
- (b) 4.0 to 50 mM of a buffering agent at a pH in the range of from 4.5 to 7.0;
- (c) 0.01 to 35% (w/v) of a tonicity and/or a stabilizing agent;
- and
- (d) 0.01 to 10% (w/v) of a surfactant;
- wherein the formulation is a single-dose or multi-dose formulation, and
- wherein the formulation retains stability for up to twenty-four months in solution.
4 more elements
Dependencies are inferred from the claim text.