Inventors:
Elizabet A. Kaisheva - Belmont CA, US
Aleni Flores-Nate - Union City CA, US
Supriya Gupta - Sunnyvale CA, US
Assignee:
Facet Biotech Corporation - Redwood City CA
International Classification:
A61K 39/395
US Classification:
4241301, 4241411, 4241441
Abstract:
This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e. g. 50 mg/ml or more, of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5. 5 to about 6. 5, about 0. 005%-0. 03% polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1 year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, and is suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.