# 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

> **NIH FDA R01** · GEORGIA INSTITUTE OF TECHNOLOGY · 2020 · $600,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10001354
- **Project number:** 5R01FD006598-03
- **Recipient organization:** GEORGIA INSTITUTE OF TECHNOLOGY
- **Principal Investigator:** JOANNE KURTZBERG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $600,000
- **Award type:** 5
- **Project period:** 2018-09-20 → 2022-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001354

## Citation

> US National Institutes of Health, RePORTER application 10001354, 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 (5R01FD006598-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10001354. Licensed CC0.

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