Viral Clearance by Flow-Through Mode Ion Exchange Columns and Membrane Adsorbers

被引：30

作者：

Miesegaes, G. R. ^{[1
]}

Lute, S. C. ^{[1
]}

Read, E. K. ^{[1
]}

Brorson, K. A. ^{[1
]}

机构：

[1] CDER FDA, Off Biotechnol Prod, Silver Spring, MD 20903 USA

来源：

BIOTECHNOLOGY PROGRESS | 2014年 / 30卷 / 01期

关键词：

monoclonal antibodies; viral clearance; anion exchange chromatography; membrane adsorbers; downstream purification; design-of-experiments; DoE; VIRUS REMOVAL; CHROMATOGRAPHY; PURIFICATION; PROTEIN; ANTIBODIES; ROBUST; MEDIA; DNA;

D O I：

10.1002/btpr.1832

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：

Anion exchange (AEX) is a common downstream purification operation for biotechnology products manufactured in cell culture such as therapeutic monoclonal antibodies (mAbs) and Fc-fusion proteins. We present a head-to-head comparison of the viral clearance efficiency of AEX adsorbers and column chromatography using the same process fluids and comparable run conditions. We also present overall trends from the CDER viral clearance database. In our comparison of multiple brands of resins and adsorbers, clearance of three model viruses (PPV, X-MuLV, and PR772) was largely comparable, with some exceptions which may reflect run conditions that had not been optimized on a resin/membrane specific basis. (c) 2013 American Institute of Chemical Engineers Biotechnol. Prog., 30:124-131, 2014

引用

页码：124 / 131

页数：8