Elizabet A. Kaisheva,Supriya Gupta,Shanti G. Duvur,Malathy Subramanian
申请号：
US13226372
公开号：
US08465739B2
申请日:
2011.09.06
申请国别(地区):
US
年份:
2013
代理人:
摘要：
This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1% polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8° C.) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. The preferred antibodies include Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody HAIL-12, a humanized anti-IL-12 monoclonal antibody HuEP5C7, a humanized anti-L selectin monoclonal antibody and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.
