Impact of cell culture on recombinant monoclonal antibody product heterogeneity

被引：38

作者：

Liu, Hongcheng ^{[1
]}

Nowak, Christine ^{[1
]}

Shao, Mei ^{[2
]}

Ponniah, Gomathinayagam ^{[1
]}

Neill, Alyssa ^{[1
]}

机构：

[1] Alex Pharmaceut, Product Characterizat, Global Analyt & Pharmaceut Dev, CT06410, Manchester, Cheshire, England

[2] Alex Pharmaceut, Global Proc Dev, Late Stage Upstream Dev, CT06410, Manchester, Cheshire, England

来源：

BIOTECHNOLOGY PROGRESS | 2016年 / 32卷 / 05期

关键词：

cell culture; posttranslational modifications; recombinant monoclonal antibodies; N-LINKED GLYCOSYLATION; UNPAIRED CYSTEINE RESIDUES; DISULFIDE BOND REDUCTION; HAMSTER OVARY CELLS; HIGH-MANNOSE; MASS-SPECTROMETRY; CHARGE VARIANTS; EXCHANGE CHROMATOGRAPHY; TRISULFIDE MODIFICATION; ASPARAGINE DEAMIDATION;

D O I：

10.1002/btpr.2327

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Recombinant monoclonal antibodies are commonly expressed in mammalian cell culture and purified by several steps of filtration and chromatography. The resulting high purity bulk drug substance still contains product variants differing in properties such as charge and size. Posttranslational modifications and degradations occurring during cell culture are the major sources of heterogeneity in bulk drug substance of recombinant monoclonal antibodies. The focus of the current review is the impact of cell culture conditions on the types and levels of various modifications and degradations of recombinant monoclonal antibodies. Understanding the relationship between cell culture and product variants can help to make consistently safe and efficacious products. (c) 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1103-1112, 2016

引用

页码：1103 / 1112

页数：10

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