乳腺生物反应器的研究和产业化进展

The Current Progress of Mammary Gland Bioreactor for Research and Industry

随着转基因技术的发展,利用乳腺生物反应器生产珍贵药用蛋白已成为一种极具潜力的生物技术,它为商业化前景广阔的药用蛋白提供了高产量、低成本的生产方式,开创了基因工程制药的新途径。目前,应用乳腺生物反应器已表达百余种药用蛋白,其中近30种进入临床试验不同阶段,用于治疗抗凝血酶缺乏症的抗凝血酶Ⅲ(ATryn)已上市,乳腺生物反应器生产重组蛋白显示出广阔的产业化前景。作者概述了乳腺生物反应器的原理、优点、国内外研究进展和产业化进程,讨论了其目前存在问题和应对策略。

With the development of transgenic technology, it has become one of promising biotechnology to produce valuable pharmaceutical proteins using mammalian mammary gland as a bioreactor. Mammary gland bioreactors offer a high-yield,low-cost way to produce bioactive commercial pharmaceutical proteins that can not be produced efficiently by other methods and initiate a new approach for genetic engineering pharmaceutics. Recombinant human proteins produced by the mammary glands of genetically modified transgenic mammals have shown great commercialization prospects. So far, more than one hundred recombinant proteins have been successfully expressed in mammalian gland bioreactors, about thirty of which are in different phases of clinical trials. Antithrombin Ⅲ （ATryn）, the first protein for human of antithrombin deficiency. Here, the principles, advantages, research advances and industrialization process of mammary gland bioreactors were reviewed and problems and strategies for protein production were also discussed.