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《中国工程科学》 >> 2016年 第18卷 第4期 doi: 10.15302/J-SSCAE-2016.04.007

新一代生物工艺研发与制造技术及高通量微小型生物反应器

1. 波士顿生物工程技术研究院,马萨诸塞州绍斯伯勒01772,美国;

2. 北京化工大学,北京100029

资助项目 :中国工程院重大咨询项目“‘十三五’战略性新兴产业培育与发展规划研究”(2014-ZD-7) 收稿日期: 2016-05-17 修回日期: 2016-06-30 发布日期: 2016-09-21

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摘要

近些年,人们认识到快速反应时间对应对烈性传染病具有至关重要的作用,然而传统工艺和技术无法有效应对。以美国卫生部为代表的机构提出并开始践行新一代工艺研发与生物制造的技术平台,其目的是要极大缩短生物工艺研发和生产的周期,从而快速应对。精准医学的发展对医药研发与生产也提出了产品研发制备周期短、种类增加、数量减少的新要求,需要新一代的研发与生产技术。实现快速研发的核心设备是微小型生物反应器,新一代技术核心包括高通量筛选、高通量工艺研发,一次性技术,模块化及柔性化生产。新一代工艺研发与生物制造技术不仅关系到国家安全、人民生命健康,其作用及影响将辐射到整个生物加工制造领域,社会与经济价值巨大。

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