公开(公告)号：US08388942B2

公开(公告)日：2013-03-05

申请号：US12150530

申请日：2008-04-29

申请人： Sidney N Wolfe ,  Bret A Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

发明人： Sidney N Wolfe ,  Bret A Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

IPC分类号： A61K38/21 ,  C07K14/565

CPC分类号： C07K14/565

摘要： Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

摘要翻译： 用于纯化和回收干扰素-β（IFN-和bgr）的改进方法和包含基本上单体的IFN- 被提供。 在一种纯化方法中，基本纯化的IFN- 或其变体沉淀，然后溶解在盐酸胍（HCl）溶液中。 蛋白质的复性通过用合适的缓冲液稀释而发生。 还提供了没有沉淀步骤的类似的纯化方法。 经IFN-α的复性后，通过渗滤或用药学上可接受的缓冲液进行透析来除去残余的胍盐，以制备基本上含有单体IFN-β的药物组合物。

公开(公告)号：US07544354B2

公开(公告)日：2009-06-09

申请号：US10035420

申请日：2001-10-25

申请人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

发明人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

IPC分类号： A61K38/21 ,  C07K17/00

CPC分类号： C07K14/565

摘要： Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

公开(公告)号：US20090123424A1

公开(公告)日：2009-05-14

申请号：US12150530

申请日：2008-04-29

申请人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

发明人： Sidney N. Wolfe ,  Bret A. Shirley ,  Susan Babuka ,  Dennis Fordham ,  Irina Esikova

IPC分类号： A61K38/21

CPC分类号： C07K14/565

摘要： Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

摘要翻译： 提供了用于纯化和回收干扰素-β（IFN-β）和包含基本上单体IFN-β的组​​合物的改进方法。 在一种纯化方法中，将基本上纯化的IFN-β或其变体沉淀，然后溶解在盐酸胍（HCl）溶液中。 蛋白质的复性通过用合适的缓冲液稀释而发生。 还提供了没有沉淀步骤的类似的纯化方法。 经IFN-β复性后，通过用药学上可接受的缓冲液进行渗滤或透析来除去HCl，以制备包含基本上单体的IFN-β的药物组合物。