Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies.
Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies.
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DOI：
10.1002/bit.25008
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发表时间：
2014-01
影响因子：
3.8
通讯作者：
Farid, Suzanne S.
中科院分区：
文献类型：
--
作者：
Simaria, Ana S.;Hassan, Sally;Varadaraju, Hemanthram;Rowley, Jon;Warren, Kim;Vanek, Philip;Farid, Suzanne S.
关键词：
为了使同种异体细胞疗法发挥其治疗潜力，需要解决与实现可扩展和稳健的制造工艺相关的挑战。一个特别的挑战是生产批量能够满足商业需求的高达109个细胞/剂量的大量患者由于目前的限制扩增技术。本文介绍了一种决策工具的应用，以确定不同生产规模的最具成本效益的扩增技术，以及目前同种异体细胞治疗制造技术能力的差距。该工具将生物工艺经济学与优化相结合，以评估平面和基于微载体的细胞扩增技术的经济竞争力。可视化方法用于确定生产规模，其中平面技术将不再具有成本效益，并且基于微载体的生物反应器成为唯一的选择。工具输出还预测，为了使该行业在高需求情景下可持续发展，可能需要显著提高基于微载体的系统的性能。使用技术S曲线以及操作窗口提供这些数据，以确定满足未来批量所需的细胞生产率和一次性生物反应器规模的组合。建模见解可用于确定未来研发投资的重点，以提高最有前途的技术的性能，使其成为一种强大且可扩展的选择，使细胞治疗行业能够达到商业相关的批量规模。工具输出可以在开发的早期促进决策，并用于预测和更好地管理产品在开发过程中所需的流程变更风险。Biotechnol. Bioeng. 2014;111：69-83.© 2013 Wiley Periodicals，Inc.
For allogeneic cell therapies to reach their therapeutic potential, challenges related to achieving scalable and robust manufacturing processes will need to be addressed. A particular challenge is producing lot-sizes capable of meeting commercial demands of up to 109 cells/dose for large patient numbers due to the current limitations of expansion technologies. This article describes the application of a decisional tool to identify the most cost-effective expansion technologies for different scales of production as well as current gaps in the technology capabilities for allogeneic cell therapy manufacture. The tool integrates bioprocess economics with optimization to assess the economic competitiveness of planar and microcarrier-based cell expansion technologies. Visualization methods were used to identify the production scales where planar technologies will cease to be cost-effective and where microcarrier-based bioreactors become the only option. The tool outputs also predict that for the industry to be sustainable for high demand scenarios, significant increases will likely be needed in the performance capabilities of microcarrier-based systems. These data are presented using a technology S-curve as well as windows of operation to identify the combination of cell productivities and scale of single-use bioreactors required to meet future lot sizes. The modeling insights can be used to identify where future R&D investment should be focused to improve the performance of the most promising technologies so that they become a robust and scalable option that enables the cell therapy industry reach commercially relevant lot sizes. The tool outputs can facilitate decision-making very early on in development and be used to predict, and better manage, the risk of process changes needed as products proceed through the development pathway. Biotechnol. Bioeng. 2014;111: 69–83. © 2013 Wiley Periodicals, Inc.
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影响因子：
20.1
作者：
Reinecke H;Minami E;Zhu WZ;Laflamme MA
通讯作者：
Laflamme MA
DOI：
10.1007/10_014
发表时间：
2006-01-01
期刊：
CELL CULTURE ENGINEERING
影响因子：
--
作者：
Farid, Suzanne S.
通讯作者：
Farid, Suzanne S.
影响因子：
4.3
作者：
Kebriaei, Partow;Isola, Luis;Uberti, Joseph
通讯作者：
Uberti, Joseph
影响因子：
6.7
作者：
Ratcliffe, Elizabeth;Thomas, Robert J.;Williams, David J.
通讯作者：
Williams, David J.
影响因子：
7.3
作者：
Delarosa O;Dalemans W;Lombardo E
通讯作者：
Lombardo E