Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine
Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine
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DOI：
10.1093/bmb/ldr037
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发表时间：
2011-12-01
影响因子：
6.7
通讯作者：
Williams, David J.
中科院分区：
文献类型：
--
作者：
Ratcliffe, Elizabeth;Thomas, Robert J.;Williams, David J.
背景资料：一个新的制造业正在出现，将独特的细胞治疗生物工艺转化为强大的，规模化的制造生产，以成功的临床translation.Source of data：本综述总结了关键的翻译问题，以及基于文献检索和作者研究的当前和未来的观点，以改善基于细胞的治疗生物工艺的翻译。人们普遍认为，基于细胞的疗法可以为一系列疾病的医疗保健带来革命性的变化，但在总体框架和技术方面仍存在差距，无法取得临床成功。由于监管和制造指南不完整，而且很少有产品实现商业化，因此对如何满足要求的理解有限。最近的发展鼓励采用自动化和质量工程方法进行细胞生物处理，及时开展研究的领域：包括技术开发，以提高生产成本和纯度以及最终产品质量。
Background: A novel manufacturing industry is emerging to translate unique cellular therapy bioprocesses to robust, scaled manufacturing production for successful clinical translation.Source of data: This review summarizes key translational issues, and current and future perspectives to improve translation of cell-based therapy bioprocessing, based on literature search and author research.Areas of agreement: It is widely recognized that cell-based therapies could revolutionize health care for a range of diseases, and that there are gaps in the overarching framework and technologies to generate clinical success.Areas of controversy: There is limited understanding of how to fulfil requirements as regulatory and manufacturing guidelines are incomplete and few have achieved commercialization.Growing points: Recent developments are encouraging adoption of automation and quality engineering approaches for bioprocessing of cell-based therapies.Areas timely for developing research: Include technology development to improve the cost and purity of manufacture and final product quality.