Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development.
Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development.
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生物学启发的微生物生理系统，以提高患者的益处和动物福利。
DOI：
10.14573/altex.2001241
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发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Roth A
中科院分区：
文献类型：
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作者：
Marx U;Akabane T;Andersson TB;Baker E;Beilmann M;Beken S;Brendler-Schwaab S;Cirit M;David R;Dehne EM;Durieux I;Ewart L;Fitzpatrick SC;Frey O;Fuchs F;Griffith LG;Hamilton GA;Hartung T;Hoeng J;Hogberg H;Hughes DJ;Ingber DE;Iskandar A;Kanamori T;Kojima H;Kuehnl J;Leist M;Li B;Loskill P;Mendrick DL;Neumann T;Pallocca G;Rusyn I;Smirnova L;Steger-Hartmann T;Tagle DA;Tonevitsky A;Tsyb S;Trapecar M;Van de Water B;Van den Eijnden-van Raaij J;Vulto P;Watanabe K;Wolf A;Zhou X;Roth A
最早的微流控微生理系统(MPS)早在15年前就进入了学术领域，被认为是一项使人类体外生物学(PECO)能够实现的技术，因此为实验室动物提供了药物开发和学术研究的替代方法。目前，该领域每年出版一千多份科学出版物。尽管MPS在学术界和平台提供商中大肆宣传，称这项技术将在基础和应用研究中重塑整个体外培养格局，但MPS方法尚未被制药行业广泛采用，也尚未达到受监管的药物授权程序。在这里，来自所有利益攸关方团体-学术界、MPS供应商行业、制药和消费品行业以及领先的监管机构-的46名领先国际专家在2019年6月的第二次此类研讨会上分析了基于MPS的检测生命周期的挑战和障碍。主要调查结果是，基于MPS的分析在特定使用环境下的合格程度以及利益攸关方之间的沟通差距是减缓最终用户工业采用的主要挑战，这反过来又造成监管接受困境。这份报告详细阐述了这些发现，并提出了解决方案，为监管机构接受基于MPS的模型提供了建议和路线图，这将使患者受益，并进一步减少药物开发中实验动物的使用。最后，讨论了基于MPS的人类疾病模型在基础生命科学研究中反馈到实验动物替代中的潜力。
The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human in vitro (patho)biology and, therefore, to provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Currently, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which say this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches neither have been widely adopted by the pharmaceutical industry yet nor have they reached regulated drug authorization processes. Here, 46 leading international experts from all stakeholder groups - academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies - analyzed challenges and hurdles along the MPS-based assay life cycle in the second workshop of its kind in June 2019. The main findings were that the level of qualification of MPS-based assays for a given context of use and communication gaps between stakeholders are the major challenges slowing industrial adoption by end users, which in turn is causing a regulatory acceptance dilemma. This report elaborates on these findings and proposes solutions by providing recommendations and a roadmap towards regulatory acceptance of MPS-based models, which will benefit patients and further reduce laboratory animal use in drug development. Finally, the potential of MPS-based human disease models to feed back into laboratory animal replacement in basic life science research is discussed.