Research Focus: Process Analytical Technology Integration for Cell Therapy Manufacturing and Process Development.

Cell therapies have the potential to treat and even cure complex, currently untreatable diseases with unprecedented success. Despite the tremendous promise, significant challenges must be overcome to make cell therapy manufacturing scalable, high-quality, and cost-effective. The many challenges are primarily because the therapy itself is composed of live cells, which are highly responsive to their surroundings and endure rigorous processing. Current cell expansion processes are unresponsive, manual, and poorly characterized. Process analytical technology (PAT) is a system to characterize, monitor, and eventually control the process to ensure final product quality. By investigating the effects of process parameters on process outputs, PAT can be implemented to modulate the process in real-time. The overall approach will be applied to Mesenchymal Stromal Cells and T Cells. The central hypothesis is that PAT integration can enhance process understanding and mitigate risks, and feedback-controlled bioreactors can improve the yield and quality of manufactured cells.

Relevant Publications:

• P. Casteleiro Costa, B. Wang, C. Filan, A. Bowles-Welch, C. Yeago, K. Roy, FE. Robles 2022. Functional imaging with dynamic quantitative oblique back-illumination microscopy. J Biomed Opt. (6) 066502.
• B. Wang, A. C. Bowles-Welch, C. Yeago, K. Roy 2022. Process analytical technologies in cell therapy manufacturing: State-of-the-art and future directions. J. Adv. Manuf. Process. 4(1).