Automated in-process characterization and selection of cell-clones for quality and efficient cell manufacturing
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SHORT COMMUNICATION
Automated in-process characterization and selection of cellclones for quality and efficient cell manufacturing Venkata P. Mantripragada . Viviane Luangphakdy . Bradley Hittle . Kimerly Powell . George F. Muschler
Received: 21 January 2020 / Accepted: 29 May 2020 Springer Nature B.V. 2020
Abstract Delivery of safe, effective and reliable cellular therapies, whether based on mesenchymal stromal cells (MSCs) or induced pluripotent stem cells (iPSCs), demand standardization of cell culture protocols. There is a need to develop automation platform that enables the users to generate culture expanded human cell populations that improves the quality and reduces batch-to-batch variation with respect to biological potential. Cell XTM robot was designed to address these current challenges in the cell fabrication industry. It utilizes non-invasive large field of view quantitative image analysis to guide an automated process of targeted ‘‘biopsy’’ (cells or media), ‘‘picking’’ (selection) of desired cells or colonies, or
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10616-020-00403-w) contains supplementary material, which is available to authorized users. V. P. Mantripragada (&) V. Luangphakdy G. F. Muschler Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA e-mail: [email protected] B. Hittle K. Powell Department of Biomedical Informatics, The Ohio State University, Columbus, OH 43210, USA G. F. Muschler Department of Orthopedic Surgery, Cleveland Clinic, Cleveland, OH 44195, USA
‘‘weeding’’ (removal) of undesired cells, thus providing an unprecedented ability to acquire quantitative measurement in a complex heterogeneous cell environment ‘‘in process’’ and then to act on those measurements to define highly reproducible methods for cell and colony ‘‘management’’ based on application specific critical quality attributes to improve the quality of the manufactured cell lines and cell products. Keywords Automation Stem-cell manufacturing Cell-picking Imaging Performance-based cell selection Stem cells
Introduction Both, induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs) represent important cell resources for cell-based therapies, disease modeling and pharmaceutical applications (Takahashi et al. 2007; Ng et al. 2017; Ramkumar et al. 2017; Stoltz et al. 2015; Piuzzi et al. 2018; Piuzzi et al. 2017; Mantripragada et al. 2019; Mantripragada et al. 2018a, b). There are currently over 800 ongoing clinical trials using MSCs as per clinicaltrials.gov records, and approximately 1900 hPSC lines, registered in hPSC registry (hPSCreg) (Kurtz et al. 2018; Seltmann et al. 2016). However, despite the enormous progress and promise, several unresolved challenges
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continue to plague the MSCs and iPSCs field including: (1) highly subjective manual decision-making steps that are ubiquitous in current cell biology an
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