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  

Advanced Bioprocess Development and Biomanufacturing Technologies and High Throughput Miniature Bioreactors

作　　者：焦鹏 陈必强[2] 

机构地区：[1]波士顿生物工程技术研究院,美国马萨诸塞州绍斯伯勒01772 [2]北京化工大学,北京100029

出　　处：《中国工程科学》2016年第4期44-50,共7页Strategic Study of CAE

基　　金：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)

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。In recent years, the importance of rapid response time to virulent infectious disease is widely recognized. However, the traditional technologies for bioprocess development and manufacturing will not succeed in winning this war. US healthcare companies and related organizations including US Department of Human Health and Service, proposed and started working on the next generation of technology platforms for advanced bioprocess development and manufacturing（ABDM）.The development of ABDM is to signifi cantly reduce the timeframe for bioprocess development and manufacturing, making it possible to promptly respond to outburst of pandemic infl uenza and prevent it from outspreading. Meanwhile, the development of precision medicine also presents new demands to the biopharmaceutical industry. With the demand of small-scale production and fast turn-around time of precision medicine, the duration of development and manufacturing needs to be accelerated signifi cantly. At the same time, the number of sub-groups of the product would increase, and the batch sizes and amount of fi nal product would decrease, as well. To satisfy the demands of small-scale production and fast turnaround time of ABDM, micro- and mini-bioreactor is the key equipment. The major technologies of ABDM include high throughput screening and process development based on micro- and mini-bioreactors, disposable technology, modular unit operations and fl exible manufacturing. The development of ABDM will directly strengthen the National Security, improve thewelfare of the people, and it also provides great social and economic values. The impact of this platform will radiate to the entire biomanufacture industry, and open a whole new era for the bioprocess development and bio-manufacturing.

关 键 词：新一代生物工艺研发与生物制造技术 烈性传染病 精准医学 微小型生物反应器 高通量技术 一次性技术 

分 类 号：Q81[生物学—生物工程]