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Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing: Bioengineering Strategies and Platform Technologies

机译:工业化细胞处理的生物反应器设计和生物过程控制:生物工程策略和平台技术

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摘要

It's official: The "Age of Cell Therapy" has arrived. A robust pipeline of cell therapies, with increasing numbers of both early-and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, stronglyindicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (l). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive, sustainable, multibillion-dollar enterprise. But when commercialization comes, will companies be ready to meet the enormous demand for viable cells? The maturing field of automated cell cultivation using highly specializedbioreactor designs and stringent bioprocess controls will be crucial for the development of biomanufacturing technologies suitable for clinical-grade production of future cytotherapeutics.
机译:官方:“细胞疗法时代”到来了。强大的细胞疗法产品线,越来越多的早期和晚期临床试验以及已经进入市场的FDA批准的商业产品,都强烈表明细胞疗法行业有望成为独特的医疗保健行业(l)。投资者兴趣的重新出现和主要制药公司之间最近的活动表明,该行业将迅速发展成为具有高度竞争力,可持续发展的数十亿美元企业的能力。但是当商业化来临时,公司是否准备好满足对活细胞的巨大需求?使用高度专业化的生物反应器设计和严格的生物过程控制的自动细胞培养的成熟领域对于开发适用于未来细胞治疗剂临床级生产的生物制造技术至关重要。

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