Скачать или смотреть Navigating the Opportunities and Challenges in Analytical Development of Flow Cytometry for T-Cell..

Presented By: Therese Choquette

Speaker Biography: With extensive experience in Cell Therapy and Analytical Development, Therese Choquette has been involved in every process stage, from early development to commercialization. At Novartis, she led the development of potency assays for the groundbreaking CAR-T product, now known as Kymriah. She then transitioned to the role of analytical project leader. After that, she joined Janssen Pharmaceuticals as an Analytical Scientific Integrator, specializing in vaccines and cell therapy products. Later, she became the Director for Global QC at Iovance Biotherapeutics, focusing on TIL cells. Now as the Head of Analytical Development in the early development of T-cell therapy products at Tigen Pharma. As a former Licensed Practical Nurse, her passion lies in providing high-quality cell therapies to patients. She constantly seeks to understand what makes a cell therapy product of the highest quality and strives to implement the best analytical methods for achieving this. During her PhD project and post-doc, her research focused on immune cells from both humans and mice, utilizing flow cytometry, immunohistochemistry, ELISA, and ELISpot techniques for the identification and functional analysis of cell populations.

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

Webinar Abstract: 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



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