公开(公告)号：US20140314748A1

公开(公告)日：2014-10-23

申请号：US14207885

申请日：2014-03-13

Applicant: F. Hoffmann-La Roche AG ,  Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF ,  Christine WURTH

IPC: A61K47/26 ,  A61K39/395

CPC classification number: A61K47/26 ,  A61K9/08 ,  A61K39/39591 ,  C07K16/22 ,  C07K16/2887

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract translation: 本发明提供了包含治疗性抗体，海藻糖，缓冲液和任选的表面活性剂，并且具有约5.5至约7.0范围内的pH的稳定的含水药物制剂。 本发明还提供了制备这些制剂的方法和使用这些制剂的方法。

公开(公告)号：US20180280514A1

公开(公告)日：2018-10-04

申请号：US15787265

申请日：2017-10-18

Applicant: Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF ,  Christine WURTH

IPC: A61K47/26 ,  C07K16/28 ,  C07K16/22 ,  A61K39/395 ,  A61K9/08

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

公开(公告)号：US20200179516A1

公开(公告)日：2020-06-11

申请号：US16723864

申请日：2019-12-20

Applicant: Genentech, Inc.

Inventor： Yatin GOKARN ,  Isidro E. ZARRAGA ,  Jonathan ZARZAR ,  Thomas PATAPOFF

IPC: A61K47/26 ,  A61K39/395 ,  A61K9/08 ,  C07K16/22 ,  C07K16/28

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

公开(公告)号：US20180120273A1

公开(公告)日：2018-05-03

申请号：US15721389

申请日：2017-09-29

Applicant: Genentech, Inc.

Inventor： Yajun WANG ,  George Tony MORENO ,  Boyan ZHANG ,  Liangyi ZHANG ,  Dell FARNAN ,  Thomas PATAPOFF

IPC: G01N30/96 ,  G01N33/68 ,  C07K1/18

CPC classification number: G01N30/96 ,  C07K1/18 ,  G01N33/6803

Abstract: The present invention provides methods for analyzing compositions of polypeptides such as antibodies by ionic strength-mediated pH gradient ion exchange chromatography. In some aspects, the methods use a combination of pH gradients and ionic strength gradients to separate the polypeptide from charge variants of the polypeptide. In some aspects, the methods use a stable ionic strength to optimize the pH gradient separation window to separate the polypeptide from charge variants. Such methods are useful for analyzing polypeptide, e.g. antibodies, with a pI greater than 9 or a pI less than 7. In some aspects, the invention provides a multiproduct method for the analysis of polypeptides of varying pI's.

公开(公告)号：US20160161455A1

公开(公告)日：2016-06-09

申请号：US14904422

申请日：2014-07-11

Applicant: GENENTECH, INC.

Inventor： Daniel MCDONALD ,  Thomas PATAPOFF ,  Yajun WANG

IPC: G01N30/86 ,  B01D15/38 ,  G01N30/96 ,  B01D15/36 ,  G01N33/68 ,  C07K1/18

CPC classification number: G01N30/8658 ,  B01D15/362 ,  B01D15/363 ,  B01D15/3847 ,  C07K1/165 ,  C07K1/18 ,  G01N30/34 ,  G01N30/96 ,  G01N33/6803 ,  G01N33/6854

Abstract: The present invention provides methods for determining chromatography separation conditions; for example, separation of a polypeptide and its charge variants. The invention also provides methods to determine a buffer condition for chromatography separation conditions. The invention also provides a robust method to analyze multiple polypeptide products.

Abstract translation: 本发明提供了测定色谱分离条件的方法; 例如分离多肽及其电荷变体。 本发明还提供了确定色谱分离条件的缓冲条件的方法。 本发明还提供了一种分析多肽产物的可靠方法。