公开(公告)号：US20140120086A1

公开(公告)日：2014-05-01

申请号：US14068074

申请日：2013-10-31

申请人： Takeda GmbH

发明人： Markus RAST ,  Peter SKUFCA ,  Wolfram STEINHILBER ,  Gerhard BECKER ,  Jurgen VOLZ ,  Wolfgang ISE

IPC分类号： A61K39/395

CPC分类号： C07K16/2887 ,  A61K39/39558 ,  A61K39/39591 ,  C07K2317/24 ,  C07K2317/76 ,  C07K2317/94

摘要： The present invention provides a method for preparation of a high concentration liquid formulation (HCLF) of an antibody or a fragment thereof. The present invention also relates to a method for stabilizing an anti-CD20 antibody or a fragment thereof in a liquid pharmaceutical formulation. Furthermore, the present invention relates to a liquid pharmaceutical formulation of a veltuzumab antibody or a fragment thereof comprising at least 155 mg/mL of a veltuzumab antibody or a fragment thereof.

摘要翻译： 本发明提供了制备抗体或其片段的高浓度液体制剂（HCLF）的方法。 本发明还涉及在液体药物制剂中稳定抗CD20抗体或其片段的方法。 此外，本发明涉及veltuzumab抗体或其片段的液体药物制剂，其包含至少155mg / mL的veltuzumab抗体或其片段。

公开(公告)号：US20160022585A1

公开(公告)日：2016-01-28

申请号：US14773478

申请日：2014-03-17

申请人： TAKEDA GMBH

发明人： Markus RAST ,  Wolfgang ISE ,  Gerhard BECKER ,  Peter SKUFCA ,  Henning GIESELER

IPC分类号： A61K9/19 ,  C07K16/28

CPC分类号： A61K9/19 ,  C07K16/2887 ,  C07K2317/24

摘要： The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

摘要翻译： 本发明提供了制备抗CD20抗体的冻干制剂的方法以及抗CD 20抗体的冻干制剂，其包含抗CD 20抗体并且具有在该范围内的残留水分含量 为1％至10％。 本发明还涉及通过本文所述的方法获得的重建制剂，所述抗体制剂作为药物的用途，所述冻干制剂在制备药物中的用途以及治疗患者的方法。

公开(公告)号：US20140271636A1

公开(公告)日：2014-09-18

申请号：US14215816

申请日：2014-03-17

申请人： Takeda GmbH

发明人： Markus RAST ,  Wolfgang ISE ,  Gerhard BECKER ,  Peter SKUFCA ,  Henning GIESELER

IPC分类号： A61K9/19 ,  C07K16/28

CPC分类号： A61K9/19 ,  C07K16/2887 ,  C07K2317/24

摘要： The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

摘要翻译： 本发明提供了制备抗CD20抗体的冻干制剂的方法以及抗CD 20抗体的冻干制剂，其包含抗CD 20抗体并且具有在该范围内的残留水分含量 为1％至10％。 本发明还涉及通过本文所述的方法获得的重建制剂，所述抗体制剂作为药物的用途，所述冻干制剂在制备药物中的用途以及治疗患者的方法。