公开(公告)号：US20140242625A1

公开(公告)日：2014-08-28

申请号：US14275055

申请日：2014-05-12

Applicant: UCB PHARMA, S.A.

Inventor： BRYAN JOHN SMITH ,  HELEN MARIE KIRKE

IPC: C12Q1/37

CPC classification number: C12Q1/37 ,  G01N33/6857 ,  G01N2333/96433

Abstract: A method of measuring acidic species generated by degradation of a Fab or Fab′ component of a Fab-PEG or a Fab′-PEG is provided. The method involves: a) cleaving PEG and a linker from the Fab-PEG or Fab′-PEG with an enzyme; b) optionally separating the PEG and linker from the Fab or Fab′ to provide isolated Fab or Fab′; and c) quantitatively analyzing acidic species associated with the cleaved Fab or Fab′ and/or the cleaved PEG.

Abstract translation: 提供了测量由Fab-PEG或Fab'-PEG的Fab或Fab'成分降解而产生的酸性物质的方法。 该方法包括：a）用酶切割PEG和Fab-PEG或Fab'-PEG的接头; b）任选地将PEG和接头与Fab或Fab'分离以提供分离的Fab或Fab'; 和c）定量分析与切割的Fab或Fab'和/或切割的PEG相关的酸性物质。