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US 2024/0191000 A1Published application
High concentration antibody formulations
AssigneeOneness Biotech Co., Ltd.
InventorsNien-Yi CHEN, Wei-Ting KAO
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Abstract
A high concentration antibody formulation comprising an antibody at a concentration of about 120-200 mg/ml, a histidine buffer at a concentration of about 5-15 mM, an amino acid at a concentration of about 1-1.5% (w/v), a tonicity modifier such as sodium chloride at a concentration of about 50-100 mM; and a non-ionic surfactant such as polysorbate 80 at a concentration of about 0.005-0.02% (w/v). In some instances, the high concentration antibody formulation may have a pH of about 5.5 to 6.5.
Claims22
An antibody formulation, comprising:
- (a) an antibody binding to a CεmX domain of a membrane-bound IgE at a concentration of about 120-200 mg/ml,
- (b) histidine at a concentration of about 5-15 mM,
- (c) an amino acid at a concentration of about 1-3.0% (w/v), wherein the amino acid is arginine or threonine;
- (d) sodium chloride at a concentration of about 50-100 mM;
- and
- (e) polysorbate 80 at a concentration of about 0.005-0.02%;
- wherein the antibody formulation has a pH of about 5.5 to 6.5.
4 more elements
Dependencies are inferred from the claim text.