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FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALFA RELATED DISORDERS
专利权人:
アッヴィ バイオテクノロジー リミテッド;ABBVIE BIOTECHNOLOGY LTD
发明人:
KRAUSE HANS-JUERGEN,ハンス-ユルゲン・クラオゼ,BAUST LISA,リサ・バオシユト,DICKES MICHAEL,ミヒヤエル・デイツケス,ハンス-ユルゲン・クラオゼ
申请号:
JP2015099796
公开号:
JP2015199741A
申请日:
2015.05.15
申请国别(地区):
JP
年份:
2015
代理人:
摘要:
PROBLEM TO BE SOLVED: To provide formulation of human antibodies for treating TNF-α related disorders.SOLUTION: The invention provides a pharmaceutical formulation selected from the group consisting of (a) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and having a shelf life of at least 18 months; (b) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and having a shelf life of at least 18 months in a liquid state; (c) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and maintaining stability after at least three cycles of freeze-and-thawing; and (d) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and maintaining enhanced stability for at least 12 months at a temperature of 2-8°C.【課題】TNF-α関連疾患の治療用ヒト抗体の製剤。【解決手段】(a)緩衝液中に治療有効量の抗体を含み、約4~8のpHと少なくとも18か月間の保存期間をもつ液体水性医薬製剤;(b)緩衝液中に治療有効量の抗体を含み、約4~8のpHと液体状態で少なくとも18か月間の保存期間をもつ水性医薬製剤;(c)緩衝液中に治療有効量の抗体を含み、約4~8のpHをもち、製剤の少なくとも3回の凍結/解凍サイクル後に安定性を維持する液体水性医薬製剤;及び(d)緩衝液中に治療有効量の抗体を含み、4~8のpHと2~8℃の温度で少なくとも12か月間の高い安定性をもつ液体水性医薬製剤から構成される群から選択される医薬製剤。【選択図】なし
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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