Baldi Lucia, Hacker David L, Adam Myriam, Wurm Florian M
Laboratory of Cellular Biotechnology, Ecole Polytechnique Fédérale de Lausanne, Station 6, 1015, Lausanne, Switzerland.
Biotechnol Lett. 2007 May;29(5):677-84. doi: 10.1007/s10529-006-9297-y. Epub 2007 Jan 19.
The expansion of the biologics pipeline depends on the identification of candidate proteins for clinical trials. Speed is one of the critical issues, and the rapid production of high quality, research-grade material for preclinical studies by transient gene expression (TGE) is addressing this factor in an impressive way: following DNA transfection, the production phase for TGE is usually 2-10 days. Recombinant proteins (r-proteins) produced by TGE can therefore enter the drug development and screening process in a very short time--weeks. With "classical" approaches to protein expression from mammalian cells, it takes months to establish a productive host cell line. This article summarizes efforts in industry and academia to use TGE to produce tens to hundreds of milligrams of r-proteins for either fundamental research or preclinical studies.
生物制品研发流程的拓展依赖于用于临床试验的候选蛋白的识别。速度是关键问题之一，而通过瞬时基因表达（TGE）快速生产用于临床前研究的高质量、研究级材料正以令人瞩目的方式解决这一因素：DNA转染后，TGE的生产阶段通常为2至10天。因此，通过TGE生产的重组蛋白（r蛋白）能够在极短时间内——数周内——进入药物研发和筛选流程。采用“经典”的哺乳动物细胞蛋白表达方法，建立一个高效的宿主细胞系需要数月时间。本文总结了工业界和学术界利用TGE生产数十至数百毫克r蛋白用于基础研究或临床前研究的工作。
