Automated, Rapid, Point-of-Collection Flow Cytometry for Leukapheresis-Derived Starting Materials
Standardizing Immunophenotyping to Support Cell and Gene Therapy
Objectives
- Evaluate performance of the automated ACCELLIX™ TBNK-16 (L) assay for phenotyping T cells, B cells, NK cells, and macrophages in leukopak products in a blood center setting.
- Compare ACCELLIX™ automated platform results to an in-house traditional flow cytometry method and workflow across a set of unique healthy donor leukopak samples.
- Evaluate precision and assay lot-to-lot reproducibility using commercial reference material.
- Assess ease of use and training requirements for operators without prior flow cytometry experience.
Summary
- The ACCELLIX™ platform provides reliable results at the point of collection through automation, and operators require minimal training and no previous experience.
- We used a set of healthy donor leukopak samples to compare TBNK cell phenotyping results from the automated TBNK-16 (L) assay to a traditional flow cytometry method and found that cell frequencies correlated strongly, despite differences in instruments, workflow, panel design, and gating methods.
- ACCELLIX™ TBNK-16 (L) assay was used to phenotype commercially-available reference material with low variability (CV < 7% across the cell phenotypes measured) and maintained accuracy and precision across different assay lots and operators.
The ACCELLIX™ platform enables automated, standardized characterization of leukapheresis-derived starting material at the point of collection, minimizing process variability and subjective data analysis, and providing rapid leukopak phenotyping for cell therapy development and manufacturing.
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