High concentration antibody and protein formulations

摘要

The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein.

主权项

1. A stable, liquid formulation of low turbidity comprising (a) an anti-IgE antibody in an amount of about 150 mg/ml, (b) arginine-HCl in an amount of 200 mM, (c) histidine in an amount of 20 mM, and (d) polysorbate in an amount of 0.01 to 0.1%, and where the formulation further has a pH of 6.0; wherein the anti-IgE antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:4.