Quality cell therapy manufacturing by design

被引：213
作者：
Lipsitz, Yonatan Y. [1 ]
Timmins, Nicholas E. [2 ]
Zandstra, Peter W. [1 ,2 ,3 ,4 ]
机构：
[1] Univ Toronto, Inst Biomat & Biomed Engn, Toronto, ON, Canada
[2] Ctr Commercializat Regenerat Med, Toronto, ON, Canada
[3] Univ Toronto, Donnelly Ctr Cellular & Biomol Res, Toronto, ON, Canada
[4] Univ Toronto, Med Design Canada Res Excellence Fund Program 1, Toronto, ON, Canada
来源：
NATURE BIOTECHNOLOGY | 2016年 / 34卷 / 04期
基金：
加拿大自然科学与工程研究理事会;
关键词：
EMBRYONIC STEM-CELLS; HUMAN HEMATOPOIETIC STEM; EX-VIVO EXPANSION; DIFFERENTIATION; CARDIOMYOCYTES; OPTIMIZATION; METABOLISM; PRODUCTS; COLONY;
D O I：
10.1038/nbt.3525
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
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.
引用
收藏
页码：393 / 400
页数：8
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