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用于视网膜细胞治疗临床研究的机器人细胞处理设施。

Robotic cell processing facility for clinical research of retinal cell therapy.

机构信息

VCCT Inc. Kobe Eye Center Building 5F, 2-1-8 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo 650-0047 Japan; Kobe City Eye Hospital. 2-1-8 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047 Japan.

Technical Research Laboratory Innovation Division, DAI-DAN Co., Ltd. 390 Kitanagai, Miyoshi-cho, Iruma-gun, Saitama 354-0044 Japan.

出版信息

SLAS Technol. 2023 Dec;28(6):449-459. doi: 10.1016/j.slast.2023.10.004. Epub 2023 Oct 29.

Abstract

The consistent production of high-quality cells in cell therapy highlights the potential of automated manufacturing. Humanoid robots are a useful option for transferring technology to automate human cell cultures. This study evaluated a robotic cell-processing facility (R-CPF) for clinical research on retinal cell therapy, incorporating the versatile humanoid robot Maholo LabDroid and an All-in-One CP unit. The R-CPF platform consists of a robot area for handling cells and an operator area for the maintenance of the robot, designed with a clean airflow to ensure sterility. Monitoring the falling, floating, and adhering bacteria demonstrated that the required cleanliness and aseptic environment for cell manufacturing were satisfied. We then conducted cell manufacturing equivalent to the transplantation therapy of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelial cells that met the clinical quality standards for transplantation. These results indicate that R-CPF is suitable for cell manufacturing purposes and suggest that utilizing the same robotic system in basic and clinical research can accelerate the translation of basic research findings into clinical applications.

摘要

细胞治疗中持续产生高质量细胞突出了自动化制造的潜力。人形机器人是将技术转移到自动化人类细胞培养中的一种有用选择。本研究评估了用于视网膜细胞治疗临床研究的机器人细胞处理设施 (R-CPF),该设施采用了多功能人形机器人 Maholo LabDroid 和 All-in-One CP 单元。R-CPF 平台由用于处理细胞的机器人区域和用于维护机器人的操作员区域组成,设计采用清洁气流以确保无菌。监测落下、漂浮和附着的细菌表明,满足了细胞制造所需的清洁度和无菌环境要求。然后,我们进行了相当于诱导多能干细胞 (iPSC) 衍生的视网膜色素上皮细胞移植治疗的细胞制造,符合移植的临床质量标准。这些结果表明 R-CPF 适合细胞制造目的,并表明在基础和临床研究中使用相同的机器人系统可以加速将基础研究结果转化为临床应用。

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