Stabilized liquid anti-RSV antibody formulations

摘要

The present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS® or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

主权项

1. A method of preventing, treating or ameliorating one or more symptoms associated with a RSV infection in a subject, said method comprising administering a prophylactically or therapeutically effective amount of a liquid palivizumab formulation, said formulation comprising in an aqueous carrier: (a) at least 15 mg/ml of palivizumab, or an antigen-binding fragment thereof; and (b) histidine at a concentration of about 1 mM to about 100 mM, wherein said formulation is substantially free of surfactant, inorganic salts or other excipients.