生物过程工程研究在创新生物医药开发中应用的驱动力——生物反应器

doi:10.16085/j.issn.1000-6613.2016.04.001

摘要/Abstract

摘要： 近年创新生物医药在生物产业中的比重逐渐增大,也给生物产业带来了巨大的经济效益,靶点筛选及分子构建等上游技术的进步是促进生物医药进步的主要原因.随着目前细胞培养技术在生物医药生产中的广泛应用,对细胞培养技术的要求也不断提高,同时细胞培养技术的实现载体——生物反应器的技术改进和创新也越发凸显其重要性.本文介绍了生物反应器在创新生物医药产业中的应用种类、发展趋势及发展驱动力,回顾了全球范围内新型生物反应器的发展成果,包括新型反应器技术及过程分析技术在生物医药中的应用,最后,分析了中国生物反应器的发展现状与问题,指出了生物反应器的发展与进步应以提高生物培养过程的稳定性最终提高产品的质量而不是以提高产量为主要目标.本文详细阐述现代生物反应器技术及基于"质量源于设计"的质量控制理念在其中所起到的关键作用,以及生物反应器的技术发展的现状和未来走向.

关键词: 生物反应器, 生物过程工程, 质量源于设计, 过程分析技术, 创新生物医药, 生物工程, 微反应器

Abstract: In recent years, the proportion of innovative biomedical in the biotechnology industry has been increasing gradually, which is mainly due to the improvement of upstream technology such as target screening and molecule construction and brings tremendous economic benefit. With the increasing applications of cell culture technology in biomedical industry, demand for its innovation has been increasing. And so it is with the equipment bioreactors. This review introduced the categories, development trend and driving force of bioreactors in biomedical industry. The achievements of novel bioreactors including the applications of novel bioreactor technology and process analytical technology are also summarized. Finally, we discussed the development status and problems of bioreactor industry in China and pointed out that increasing the product quality rather than production is the goal of bioreactor development. This review also expounded the key role of modern bioreactor technology and the "Quality by Design" principles of, as well as the developmenet status and trend of bioreactor technology.

Key words: bioreactor, biological process engineering, quality by design, PAT, innovative bio-pharmaceutical, biological engineering, microreactor

中图分类号:

Q815

孙杨, 聂简琪, 刘秀霞, 杨艳坤, 戴晓峰, 白仲虎. 生物过程工程研究在创新生物医药开发中应用的驱动力——生物反应器[J]. 化工进展, 2016, 35(04): 971-980.

SUN Yang, NIE Jianqi, LIU Xiuxia, YANG Yankun, DAI Xiaofeng, BAI Zhonghu. Pioneering application of biological process engineering in innovative bio-pharmaceutical development——bioreactors[J]. Chemical Industry and Engineering Progree, 2016, 35(04): 971-980.

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