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Cell Manufacturing Research at Georgia Tech

What do we do?

We focus on cell manufacturing research (early stage improvements in QA/QC, process optimization, scale-up and automation processes). We partner with clinical and commercial entities to increase the reproducibility and speed of their manufacturing processes, to increase potency and to lower cost.

Project types at GT

1. Cell characterization projects

• Clinical grade cell analysis: (expanded text: Supporting clinical partners with in-depth characterization to ensure safety, efficacy, and regulatory compliance.)

• Commercial cell profiling (expanded text: Enhancing product consistency and performance through robust analytical methods tailored for commercial applications.)

• National recognition: Designated as the only In-Depth Cell Characterization Hub in the U.S. for NIH’s Regenerative Medicine Innovation Project: https://www.nih.gov/rmi.

2. Platform tools and technology development

• Advanced Characterization and analytics for critical quality attributes (expanded text: Developing tools to identify and monitor critical quality attributes (CQAs) essential for consistent and effective cell therapies.

• Process development and automation (expanded text: Innovating scalable, automated solutions to streamline manufacturing workflows and reduce variability.)

• Collaborative Innovation: Driving automation research in partnership with GTRI and through our NSF-funded Engineering Research Center. Learn more: https://cellmanufacturingusa.org/research

Why are we unique?

We offer the rare combination of tools and expertise that bridges the gap between basic science and translational technology in cell therapy development. Our integrated approach enables the co-development of:

· Cell characterization – deep phenotyping, potency assays and quality metrics

· Manufacturing technologies – automation, scale-up and process optimization

This iterative and collaborative model accelerates innovation, ensuring scientific discovery and manufacturing evolve hand-in-hand.

What types of cells do we characterize?

Our platforms and characterization workflows are cell agnostic, enabling broad application across therapeutic areas:

· Autologous cells – patient derived cells for personalized therapies

· Allogenic cells – donor derived cells for scalable off the shelf solutions

· Genetically-modified cells – engineered cells for targeted therapeutic functions

· Cells across therapeutic areas – from ophthalmology to orthopaedics to oncology, our capabilities span a wide range of clinical applications

· Explore our NIH-supported work – for an sample (not comprehensive) of the cell types characterized through our NIH award, please see: https://www.nih.gov/rmi/funded-awards

For more information contact:

Dr. Johnna S. Temenoff, Wallace H. Coulter Distinguished Chair and Director, CMaT and Marcus Center of Excellence in Cell Biomanufacturing

Ph: (404)385-5026

Email: johnna.temenoff@bme.gatech.edu