Comparative Evaluation of Automated and Conventional Flow Cytometry Methods for Leukapheresis characterization upon Cryopreservation Processes
Description: Leukapheresis products stand at the foundation of cell and gene therapy manufacturing, serving as critical starting materials whose cellular composition directly influences both process performance and clinical outcomes. While cryopreservation has enabled more flexible and decentralized workflows, it remains limited by a lack of standardized approaches for robust and reproducible sample characterization. Traditionally, cellular characterization has been performed only after thawing, offering a limited window into process variability. The introduction of automated flow cytometry checkpoints marks a significant evolution, enabling real-time monitoring of cellular populations at critical cryopreservation stages. IntegriCell® cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. An expanding network of cryopreservation centers across the United States and Europe allows leukapheresis products to be processed and cryopreserved within 24 hours of collection, in close proximity to the patient.
- The first objective of this study was to compare the analytical performance of a conventional flow cytometry method with the automated Accellix platform for the characterization of lymphocyte subpopulations in cryopreserved leukapheresis samples.
- The second objective was to evaluate the ability of the Accellix automated platform to monitor changes in key lymphocyte subpopulations throughout the leukapheresis cryopreservation process, from the fresh material to the final cryopreserved product.
This study demonstrates the ability of the Accellix Platform to deliver robust and reproducible monitoring of key lymphocyte subpopulations (CD45+, CD3+, CD4+ and CD8+) throughout leukapheresis and cryopreservation, with consistent performance across assays and independent production runs.
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