公开(公告)号：US20180120273A1

公开(公告)日：2018-05-03

申请号：US15721389

申请日：2017-09-29

申请人： Genentech, Inc.

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

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

CPC分类号： G01N30/96 ,  C07K1/18 ,  G01N33/6803

摘要： 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.