Flow cytometric analysis for cellular therapy products: design and practical considerations

Flow cytometry is the most commonly used technique for quality control of cellular therapy products. In developing and then validating flow cytometry QC assays for living medicines, these research-originated assay techniques must be made sufficiently robust for manufacturing use. Key to success is truly understanding all the aspects of design and validation that a GMP-compliant process entails. In this translational insight paper, the authors highlight major themes found in designing and applying flow cytometric analysis for cellular therapies and discuss practical solutions to common problems.

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