Anti-il-9 antibody formulations and uses thereof

Abstract

The present invention provides liquid formulations of antibodies or antibody fragments that immunospecifically bind to an IL-9 polypeptide, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of the antibodies or antibody fragments, even during long periods of storage. In particular, the present invention provides liquid formulations of antibodies or fragments thereof that immunospecifically bind to an IL-9 polypeptide, which formulations are substantially free of surfactants, sugars, sugar alcohols, amino acids other than histidine (preferably with pKa values of less than 5 and above 7), and / or other common excipients. Furthermore, the invention provides methods of preventing, treating or ameliorating a disease or disorder associated with or characterized by aberrant expression and / or activity of an IL-9 polypeptide, a disease or disorder associated with or characterized by aberrant expression and / or activity of the IL-9R or one or more subunits thereof, an autoimmune disease, an inflammatory disease, a proliferative disease, or an infection (preferably, a respiratory infection), or one or more symptoms thereof, utilizing the liquid formulations of the present invention.

Description

[0001]This application claims the benefit of U.S. Provisional Application No. 60 / 561,845, filed Apr. 12, 2004, which is incorporated by reference herein in its entirety.1. INTRODUCTION[0002]The present invention relates to high concentration liquid formulations of antibodies or fragments thereof that immunospecifically bind to an IL-9 polypeptide, which formulations exhibit stability, low to undetectable levels of antibody fragmentation, low to undetectable levels of aggregation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. In particular, the present invention relates to liquid formulations of antibodies (including antibody fragments thereof) that immunospecifically bind to an IL-9 polypeptide, which formulations are substantially free of surfactants, sugars, sugar alcohols and / or amino acids other than histidine. The present invention also relates to methods of preventing, treating, managing or ameliorating symptoms...

AI Technical Summary

Benefits of technology

The liquid formulations provide a stable, ready-to-use solution that maintains biological activity, simplifying administration and reducing waste, with enhanced storage stability and reduced risk of adverse effects.

Problems solved by technology

Lyophilized formulations of antibodies have a number of limitations, including a prolonged process for lyophilization and resulting high cost for manufacturing.

Such reconstitution procedure is cumbersome and the time limitation after the reconstitution can cause a great inconvenience in administering the formulation to patients, leading to significant waste, if not reconstituted properly or if the reconstituted dose is not used within six (6) hours and must be discarded.

Prior liquid antibody preparations have short shelf lives and may lose biological activity of the antibodies resulting from chemical and physical instabilities during the storage.

Chemical instability may be caused by deamidation, racemization, hydrolysis, oxidation, beta elimination or disulfide exchange, and physical instability may be caused by antibody denaturation, aggregation, precipitation or adsorption.

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