Implementing Dynamic Automated Flow Cytometric Analysis for Rapid Cell Therapy Manufacturing QC
The Value of Automated Data Analysis – Cell subset frequencies and counts are used for cell therapy analytical and process development, as well as for decision making during the manufacturing and release of drug products. Ambiguity in threshold placement due to noisy or poorly defined borders between cell populations leads to inherent subjectivity, inconsistent results, and increased measurement uncertainty. Consistency in how thresholds are placed is crucial for setting quantitative acceptance criteria for QC test results and reproducibly manufacturing a cell therapy. Automating flow cytometric analysis enables all levels of technicians to generate accurate and precise cell enumeration and phenotyping results in real time, providing actionable in-process information.
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