Production of target-specific recombinant human polyclonal antibodies in mammalian cells
Production of target-specific recombinant human polyclonal antibodies in mammalian cells
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DOI：
10.1002/bit.20865
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发表时间：
2006-06-05
影响因子：
3.8
通讯作者：
Tolstrup, Anne B.
中科院分区：
文献类型：
--
作者：
Wiberg, Finn C.;Rasmussen, Soren K.;Tolstrup, Anne B.
我们描述了第一靶特异性重组人多克隆抗体的表达和一致性生产。通过新型Sympress表达技术制备了由25种独特的人IgG 1抗体组成的抗Rhesus D重组多克隆抗体Sym 001。该策略基于使用FRT/FIp-In重组酶系统在CHO细胞中位点特异性整合抗体基因。这允许表达构建体整合在宿主细胞中的相同基因组位点，从而减少基因组位置效应。Sym 001的不同生物反应器批次显示出高度一致的生产产率、抗体组成、结合效价和功能活性。结果表明，在直接适用于工业生产环境的条件下，可以可重复地产生不同的重组人多克隆抗体组合物，并提供了可用于治疗新生儿溶血病和/或特发性血小板减少性紫癜的第一重组多克隆抗体。(c)2006 Wiley Periodicals，Inc.
We describe the expression and consistent production of a first target-specific recombinant human polyclonal antibody. An anti-Rhesus D recombinant polyclonal antibody, Sym001, comprised of 25 unique human IgG1 antibodies, was produced by the novel Sympress expression technology. This strategy is based on site-specific integration of antibody genes in CHO cells, using the FRT/FIp-In recombinase system. This allows integration of the expression construct at the same genomic site in the host cells, thereby reducing genomic position effects. Different bioreactor batches of Sym001 displayed highly consistent manufacturing yield, antibody composition, binding potency, and functional activity. The results demonstrate that diverse recombinant human polyclonal antibody compositions can be reproducibly generated under conditions directly applicable to industrial manufacturing settings and present a first recombinant polyclonal antibody which could be used for treatment of hemolytic disease of the newborn and/or idiopathic thrombocytopenic purpura. (c) 2006 Wiley Periodicals, Inc.