Reproducible and Efficient Phenotyping for Cell Therapy Manufacturing Using the Accellix Automated Flow Cytometer...

Measuring cellular quality attributes of cell therapy products is crucial because it ensures their safety, purity, potency, identity, and stability. These attributes help determine whether the therapy is effective and consistent across batches. Since cell therapy products are biologically complex, assessing their quality helps maintain lot-to-lot consistency, supports clinical data generation, and ensures compliance with regulatory standards. Additionally, critical quality attributes are essential for monitoring process control and validating the therapy's effectiveness. Many of these cellular quality attributes are assessed using flow cytometry; however, beyond well-established clinical immunophenotyping assays, the technology remains insufficiently standardized, complicating alignment with Good Manufacturing Practice and regulatory expectations. The work outlined here assesses the feasibility of the Accellix Platform for automated cellular sample analysis by analyzing repeatability and reproducibility across sites, operators, and dedicated instruments. The data presented demonstrate the potential of combining cytometry automation with advanced T cell engineering techniques to achieve robust and compliant manufacturing processes for innovative cellular therapies.