C-terminal modification of monoclonal antibody drugs: amidated species as a general product-related substance.

Abstract:

:Twelve therapeutic mAbs, comprising 10 IgG1s and 2 IgG4s, were analyzed by a peptide mapping technique to detect and quantify C-terminal modifications. C-terminal amidated structures were found in 8 out of the 12 mAbs. An in vitro study using a commercially available peptidylglycine alpha-amidating monooxygenase (PAM) revealed that both IgG1 and IgG4 can be substrates for PAM. This study showed that C-terminal amidation is a general C-terminal modification on the heavy chains of therapeutic mAbs and that C-terminal amidation of mAbs can be catalyzed by a certain PAM(s) in the Chinese hamster ovary (CHO) cells that are widely used for manufacturing therapeutic mAbs.

journal_name

Int J Biol Macromol

authors

Tsubaki M,Terashima I,Kamata K,Koga A

doi

10.1016/j.ijbiomac.2012.09.016

subject

Has Abstract

pub_date

2013-01-01 00:00:00

pages

139-47

eissn

0141-8130

issn

1879-0003

pii

S0141-8130(12)00370-4

journal_volume

52

pub_type

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