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

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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.