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Bryan Wang
BioE Ph.D. Proposal Presentation
10:00AM, Wednesday, May 11, 2022
Location: CHOA EBB and BlueJeans: https://bluejeans.com/127673857/2821
Meeting ID: 127 673 857
Committee Members:
Krishnendu Roy, Ph.D. (Advisor), Department of Biomedical Engineering, Georgia Institute of Technology & Emory University
Carolyn Yeago, Ph.D. (Co-Advisor), Marcus Center for Therapeutic Cell Characterization and Manufacturing
Johnna Temenoff, Ph.D., Department of Biomedical Engineering, Georgia Institute of Technology & Emory University
Fani Boukuvala, Ph.D. School of Chemical & Biomolecular Engineering, Georgia Institute of Technology
Stephen Balakirsky, Ph.D., Georgia Tech Research Institute
Process Development and Process Analytical Technology Integration for Cell Therapy Manufacturing
Cell therapies have the potential to effectively treat and even cure complex, currently untreatable diseases with unprecedented success. Despite the tremendous promise, significant and unique challenges must be overcome to make cell therapy manufacturing reproducible, scalable, high-quality, and cost-effective. The many challenges of cell therapy manufacturing are primarily because the therapy itself is composed of live cells. Cells are highly responsive to their surrounding conditions and endure rigorous processing from procurement to administration into a patient. The upstream cell expansion process is critical for producing high-yield and high-quality cell products. This step utilizes bioreactors as a unit operation to cultivate desired cell types. Current bioreactors for cell therapies are unresponsive, manual, and poorly characterized for each specific product. Process analytical technology (PAT) is a system to characterize, monitor, and eventually control the process to ensure final product quality. PAT is a powerful tool that has been successfully implemented in the pharmaceutical industry but remains mostly unexplored in the cell therapy industry. This thesis project aims to (1) design bench-scale bioreactors and processes configurable to PAT integration; (2) utilize PAT and biological assays to characterize expansion processes and products to determine critical process parameters; (3) compare different bioreactor types and use PAT to understand how process parameters contribute to product differences. The overall approach will be applied to two different cell types: Mesenchymal Stromal Cells and T Cells, each requiring a unique culture environment. The overall objective of this thesis is to leverage engineering tools to better understand the biology behind the cell expansion processes in bioreactors. The central hypothesis is that bioreactors can effectively expand therapeutic cells, and PAT integration on bioreactors can enhance process understanding and mitigate risks associated with at-scale cell therapy manufacturing.
