Data Enabled Automation for the Improved Efficiency, Yield, and Reproducibility of the Manufacturing of Human Umbilical Cord Tissue Mesenchymal Stromal Cells for Clinical Therapeutic Use

数据支持的自动化可提高临床治疗用途的人脐带组织间充质基质细胞的制造效率、产量和可重复性

• 批准号: 10001354
• 负责人: JOANNE KURTZBERG
• 金额: $ 60万
• 依托单位: GEORGIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001354
• 关键词: Data; Enabled; Automation; Improved; Efficiency

Project Summary Mesenchymal stromal cells (MSCs) are emerging as an important therapeutic cell for many serious medical conditions with unmet medical needs, like autism, arthritis, stroke, diabetes, and heart failure. If MSCs are effective for even one of these conditions, the number of doses needed per year will exceed 100,000-500,000, and current manufacturing processes cannot meet this demand. This project will provide multiple manufacturing process innovations to increase the efficiency and reproducibility while decreasing the cost of MSC manufacturing to meet the anticipated demand for these revolutionary therapies. The research team brings together two major centers: The Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) at Georgia Tech and the Marcus Center for Cellular Cures (MC3) at Duke University. The effective collaboration between the bioengineers, industrial engineers and sensors experts, robotics and automation experts, and clinicians with deep experience in cell therapies and GMP production ensure that the transformative solutions for scalable manufacturing of human cord tissue (hCT) MSCs will significantly impact both short term clinical needs as well as enable long term industry need for quality-driven, sensor-based, feedback-controlled automated bioprocesses. Specifically this project aims to 1) define critical quality attributes (CQAs) and the corresponding critical process parameters (CPPs) necessary to move from medium scale static production to large scale, responsive production of hCT-MSCs, 2) develop wireless sensor technology to continuously monitor glucose/lactate levels and cell growth characteristics (rate and density), and 3) create automated and responsive unit operations for maintaining culture efficiency, increasing culture reproducibility, and reducing labor requirements. The innovations realized from this work will close current gaps within the cell manufacturing field and will readily amenable to industrial applications to support scaled production of therapeutic cells.

项目概要 间充质基质细胞 (MSC) 正在成为许多严重医学疾病的重要治疗细胞 医疗需求未得到满足的疾病，如自闭症、关节炎、中风、糖尿病和心力衰竭。如果 MSC 是 即使对其中一种病症有效，每年所需的剂量也将超过 100,000-500,000 剂， 而现有的制造工艺无法满足这一需求。该项目将提供多种制造 工艺创新可提高效率和重现性，同时降低 MSC 成本 制造以满足这些革命性疗法的预期需求。研究团队带来 两个主要中心：马库斯治疗细胞表征和制造中心 (MC3M) 佐治亚理工学院和杜克大学马库斯细胞治疗中心 (MC3)。有效的协作 生物工程师、工业工程师和传感器专家、机器人和自动化专家之间，以及 在细胞疗法和 GMP 生产方面拥有丰富经验的临床医生可确保变革性解决方案 人类脐带组织 (hCT) MSC 的可扩展生产将显着影响短期临床 需求并满足行业对质量驱动、基于传感器、反馈控制的自动化的长期需求 生物过程。具体来说，该项目旨在 1) 定义关键质量属性 (CQA) 和相应的 从中型静态生产转向大规模所需的关键工艺参数（CPP）， hCT-MSC 的响应式生产，2) 开发无线传感器技术以持续监测 葡萄糖/乳酸水平和细胞生长特征（速率和密度），3) 创建自动化和响应式 维持培养效率、提高培养再现性和减少劳动力的单元操作 要求。这项工作实现的创新将缩小电池制造领域当前的差距 并且易于工业应用以支持治疗细胞的规模化生产。