Navigating the Opportunities and Challenges in Analytical Development of Flow Cytometry for T-Cell Therapy: A Primer for Cell Therapy Guidelines and Panel Discussion

Flow cytometry plays a crucial role in the rapidly growing field of cell therapy, this method is used to identify different types of cells throughout the manufacturing process, from initial screening to final product assessment. Flow cytometry provides valuable insights into the starting material, product characteristics, and functional assessments. As the technology advances, the number of markers and fluorophores that can be used in a single panel is increasing. However, the field faces challenges such as a need for more standardization, limited reference materials, and subjective data analysis. Guidelines are still very general for cell therapy applications, and harmonized validation protocols are lacking. This makes method qualification and validation complex and resource-intensive. In this presentation, we will delve into these challenges and explore how new tools for flow cytometry can enhance the qualification and validation process. The webinar will close with a 20-minute panel discussion with experts to speak about the next steps for harmonized protocols in cell therapy.

 

Panelists will include:

 

Heba Degheidy, MD, PhD of FDA, CBER, OTAT

Virginia Litwin, PhD, Director of Scientific Affairs at Eurofins

Lili Wang (Fed), PhD, Research Chemist at NIST

Daniel Baker, PhD student,  University of Pennsylvania School of Medicine

 

Learning Objectives