Office of Biotechnology Products,CDER/FDA, 10903 New Hampshire Ave., Silver Spring, MD, 20903.
Biotechnol Prog. 2014 Jan-Feb;30(1):124-31. doi: 10.1002/btpr.1832. Epub 2013 Nov 18.
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.
阴离子交换（AEX）是细胞培养生产的生物技术产品（如治疗性单克隆抗体（mAbs）和 Fc 融合蛋白）的常见下游纯化操作。我们使用相同的工艺流体和可比的运行条件，对 AEX 吸附剂和柱层析的病毒清除效率进行了直接比较。我们还展示了来自 CDER 病毒清除数据库的总体趋势。在对多种品牌的树脂和吸附剂的比较中，三种模型病毒（PPV、X-MuLV 和 PR772）的清除效果基本相当，也有一些例外情况，这可能反映了在树脂/膜特定基础上没有优化的运行条件。
