U.S. Food and Drug Administration, Center for Biologics Research and Evaluation, Silver Spring, MD 20993, USA.
Otto H. York Department of Chemical, Biological, and Pharmaceutical Engineering, New Jersey Institute of Technology, Newark, NJ 07102, USA.
Trends Biotechnol. 2018 Jan;36(1):105-118. doi: 10.1016/j.tibtech.2017.10.007. Epub 2017 Nov 7.
Heterogeneity in cell function has presented a significant hurdle to the successful clinical translation of many cellular therapies. Current techniques for assessing cell quality and the effects of microenvironmental cues and manufacturing processes on cell behavior often inadequately address heterogeneity due to issues such as population versus single-cell measurements and the therapeutic relevance and throughput/robustness of the assay. Due to the well-established relationship between morphology and cellular function, morphological profiling has become increasingly utilized to better understand functional heterogeneity and its impact on therapeutic development. In this review, we introduce an emerging field we term functionally-relevant morphological profiling with great potential to improve our understanding of cellular heterogeneity through discovering novel quality attributes, optimizing manufacturing, and screening drugs/biomaterials.
细胞功能的异质性给许多细胞疗法的成功临床转化带来了重大障碍。目前用于评估细胞质量以及微环境线索和制造工艺对细胞行为影响的技术，由于群体与单细胞测量的差异，以及分析的治疗相关性、通量/稳健性等问题，往往不能充分解决异质性问题。由于形态与细胞功能之间存在着明确的关系，形态分析已越来越多地被用于更好地理解功能异质性及其对治疗开发的影响。在这篇综述中，我们介绍了一个新兴领域，我们称之为与功能相关的形态分析，它具有通过发现新的质量属性、优化制造和筛选药物/生物材料来提高我们对细胞异质性的理解的巨大潜力。
