Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems
Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems
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DOI：
10.1007/978-1-4939-3584-0_22
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发表时间：
2016-01-01
期刊：
影响因子：
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通讯作者：
Cabral, Joaquim M. S.
中科院分区：
文献类型：
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作者：
Fernandes-Platzgummer, Ana;Carmelo, Joana G.;Cabral, Joaquim M. S.
间充质干/基质细胞（MSC）的治疗潜力已经引发了在大量临床应用中对高细胞剂量的需求。这一需求需要开发符合良好生产规范（GMP）的离体扩增方案，该方案应该有效地以安全和具有成本效益的方式提供临床级细胞的稳健和可再现的供应。在无异种（xeno）培养条件下的受控搅拌罐生物反应器系统为开发和优化细胞制造提供了理想的设置，以满足用于细胞疗法的人MSC的标准和需求。在此，我们描述了两种基于微载体的搅拌培养系统，使用转瓶和受控搅拌罐生物反应器在无异种条件下有效地体外扩增人骨髓和脂肪组织来源的MSC。
The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.