公开(公告)号：EP3092010A2

公开(公告)日：2016-11-16

申请号：EP15700117.3

申请日：2015-01-09

申请人： Synthon Biopharmaceuticals B.V.

发明人： ROO DE, Guy ,  VERSTEGEN, Ruud Martin ,  COUMANS, Rudy Gerardus Elisabeth

IPC分类号： A61K47/48

CPC分类号： A61K47/48384 ,  A61K47/6803 ,  A61K47/6851 ,  A61K47/6889 ,  C07K16/32

摘要： The present invention relates to a method for purifying a mixture of cysteine-linked antibody-drug conjugates, wherein the amount of non-conjugated antibody is in the range of 0-40% by weight, using hydrophobic interaction chromatography (HIC). The mixture is loaded onto a preparative HIC column using a 0.2-1.5 M aqueous salt solution, in which non-conjugated antibody is collected in a flow-through fraction, followed by elution of a purified mixture of cysteine-linked antibody-drug conjugates using a 0-100 mM aqueous salt solution.

摘要翻译： 本发明涉及使用疏水相互作用色谱法（HIC）纯化半胱氨酸连接的抗体 - 药物缀合物的混合物的方法，其中非缀合抗体的量在0-40重量％的范围内。 使用0.2-1.5M盐酸水溶液将混合物加载到制备型HIC柱上，其中在流通级分中收集未缀合的抗体，随后使用半胱氨酸连接的抗体 - 药物缀合物的纯化混合物洗脱 0-100mM的盐水溶液。

公开(公告)号：EP3092010B1

公开(公告)日：2018-07-11

申请号：EP15700117.3

申请日：2015-01-09

申请人： Synthon Biopharmaceuticals B.V.

发明人： ROO DE, Guy ,  VERSTEGEN, Ruud Martin ,  COUMANS, Rudy Gerardus Elisabeth

IPC分类号： A61K47/68 ,  C07K16/32

CPC分类号： C07K16/32 ,  A61K47/6803 ,  A61K47/6851 ,  A61K47/6889

摘要： The present invention relates to a method for purifying a mixture of cysteine-linked antibody-drug conjugates, wherein the amount of non-conjugated antibody is in the range of 0-40% by weight, using hydrophobic interaction chromatography (HIC). The mixture is loaded onto a preparative HIC column using a 0.2-1.5 M aqueous salt solution, in which non-conjugated antibody is collected in a flow-through fraction, followed by elution of a purified mixture of cysteine-linked antibody-drug conjugates using a 0-100 mM aqueous salt solution.