Quality cell therapy manufacturing by design
Quality cell therapy manufacturing by design
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DOI：
10.1038/nbt.3525
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发表时间：
2016-04-01
影响因子：
46.9
通讯作者：
Zandstra, Peter W.
中科院分区：
文献类型：
--
作者：
Lipsitz, Yonatan Y.;Timmins, Nicholas E.;Zandstra, Peter W.
活细胞移植作为治疗剂有望为广泛的急性和慢性疾病提供新的治疗选择。然而，细胞的生物复杂性阻碍了将实验室规模的实验转化为可靠的、具有成本效益的细胞疗法制造的工业过程。我们认为，解决这一挑战的方法是根据设计质量（QbD）原则设计电池制造工艺。QbD将科学知识和风险分析集成到制造工艺开发中，并已被生物制药行业采用。虽然需要进一步的技术发展才能完全实现，但将QbD纳入细胞治疗制造的机会很多。通过QbD将细胞群的可测量分子和细胞特征与最终产品质量联系起来，是实现细胞疗法改变医疗保健的潜力的关键一步。
Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.