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Stable liquid pharmaceutical formulation of IGG antibody
专利权人:
アッヴィ・バイオセラピューティクス・インコーポレイテッド
发明人:
カイシェバ,エリザベット エー.,グプタ,シュプリヤ,ドブール,シャンティ ジー.,サブラマニアン,マラシー,カイシェバ,エリザベット エー.,グプタ,シュプリヤ,ドブール,シャンティ ジー.,サブラマニアン,マラシー
申请号:
JP2003541777
公开号:
JP5290489B2
申请日:
2002.11.08
申请国别(地区):
JP
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.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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