CHARLENE E BRISBANE,シャーレーン・イー・ブリスベーン,AMOL SHARAD KETKAR,アモル・シャラド・ケトカー,LASHMAR ULLA TOVE,ウラ・トーベ・ラシュマー
申请号:
JP2013229307
公开号:
JP2014062100A
申请日:
2013.11.05
申请国别(地区):
JP
年份:
2014
代理人:
摘要:
PROBLEM TO BE SOLVED: To provide shear and temperature stable antibody formulations that are more stable than a standard formulation (e.g., 30 mM of citrate, 100 mM of NaCl, and the pH of 6.5) for an anti-CD20 (human B-lymphocyte-restricted differentiation antigen) antibody.SOLUTION: An anti-CD20 antibody formulation comprises a therapeutically effective amount of an anti-CD20 antibody. The formulation further comprises 10 to 100 mM of sodium acetate, 25 to 100 mM of sodium chloride, 0.5 to 5% of arginine free base, 0.02 to 0.2 mM of EDTA, and 0.01 to 0.2% of polysorbate 80 and is adjusted to a pH of 5.0 to 7.0.COPYRIGHT: (C)2014,JPO&INPIT【課題】抗CD20(ヒトBリンパ球限定分化抗原)抗体で、標準処方(30mMクエン酸塩、100mM NaCl、pH6.5など)に比べてより安定であるせん断および温度安定性抗体処方の提供。【解決手段】治療上有効な量の抗CD20抗体を含む抗CD20抗体処方であって、10~100mM酢酸ナトリウム、25~100mM塩化ナトリウム、0.5~5%アルギニン遊離塩基、0.02~0.2mM EDTA、0.01~0.2%ポリソルベート80をさらに含み、pH5.0~7.0に調整した抗CD20抗体処方。【選択図】なし