使用蛋白质a膜快速净化mAb,产生高HCP清除率
Nils Gehrmann1, Andreas Daxbacher1, Rainer Hahn1
1Institute of Bioprocess Science and Engineering, Department of Biotechnology. University of Natural Resources and Life Sciences, Muthgasse 18, 1190 Vienna, Austria.
概括
这项研究评估了三种蛋白质A膜用于单克隆抗体净化. 所有膜都有效地去除了杂质,Sartobind® Rapid A和HiTrap FibroTM PrismA在短时间内显示出高结合能力.
科学领域:
- 生物技术是生物技术.
- 生物加工是一种生物加工.
- 染色体学 染色体学 是一种染色学.
背景情况:
- 由于其特异性,蛋白A染色体对于单克隆抗体 (mAb) 净化至关重要.
- 膜吸附剂提供快速生物分子净化作为传统色谱树脂的替代品.
研究的目的:
- 为了评估和比较三种商业蛋白质A膜用于mAb净化.
- 评估膜在流量分布,透性和结合能力方面的性能.
- 为了研究细胞培养超剂 (CCS) 应用中的洗步骤中的杂质去除和回收.
主要方法:
- 已经测试了Sartobind®快速A,HiTrap FibroTM PrismA和GORETM蛋白质捕获装置.
- 评估流量分布,透性和结合性能.
- 将膜应用于含有mAbs的CCS,优化酸性和高pH洗步骤.
主要成果:
- 所有测试的膜都显示出高生产率和有效的移除宿主细胞蛋白质 (HCP) 和DNA.
- GORETM蛋白质捕获装置显示出良好的流量分布,但在高流量时面临扩散限制.
- 尽管水力动力学存在局限性,但Sartobind® Rapid A和HiTrap FibroTM PrismA在低于12秒的停留时间下实现了约40g/L的结合能力.
结论:
- 蛋白A膜吸附器是mAb捕获的可行,高生产率的替代品.
- 特定的膜设计会影响性能,并有可能优化外和流动动力学.
- 进一步开发可以提高基于膜的蛋白质A染色体的生物制药制造效率.
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