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.
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