Zhou Joe X, Tressel Tim
Department of Purification Process Development, AMGEN Inc., One Amgen Center Drive, Thousand Oaks, California 91320, USA.
Biotechnol Prog. 2006 Mar-Apr;22(2):341-9. doi: 10.1021/bp050425v.
The large-scale production of recombinant human monoclonal antibodies demands economical purification processes with high throughputs. In this article we briefly describe a common antibody process and evaluate the Q membrane adsorber for process-scale antibody production as an alternative to a Q-packed-bed column in a flow-through mode. The scientific concepts underlining Q membrane technology and its application are reviewed. The disadvantages and advantages of using Q membrane chromatography as a purification unit in large-scale production are discussed, including problems initially seen with the Q membrane scale-down model but solved with the invention of a new scale-down model. The new Q-membrane unit operation has a process capacity greater than 3,000 g/m(2) or 10.7 kg/L with a LRV over 5 for four model viruses. In this Review, a cost analysis illustrates that Q membrane chromatography is a viable alternative to Q column chromatography as a polishing step in a flow-through mode for process-scale antibody production.
重组人单克隆抗体的大规模生产需要经济且高通量的纯化工艺。在本文中，我们简要描述了一种常见的抗体工艺，并评估了Q膜吸附器在工艺规模抗体生产中的应用，以替代流通模式下的Q填充床柱。对Q膜技术的科学概念及其应用进行了综述。讨论了在大规模生产中使用Q膜色谱作为纯化单元的缺点和优点，包括最初在Q膜缩小模型中遇到但通过新缩小模型的发明得以解决的问题。新的Q膜单元操作对四种模型病毒的处理能力大于3000 g/m²或10.7 kg/L，线性分辨率（LRV）超过5。在本综述中，成本分析表明，在流通模式下，Q膜色谱作为工艺规模抗体生产的抛光步骤，是Q柱色谱的可行替代方案。
