From Variability to Consistency: Cryoport's Experience with the ACCELLIX™ automated flow cytometry platform
Cell and Gene Therapy manufacturers continue to face a common challenge: variability in cellular starting materials. As therapies scale globally, consistent characterization of leukapheresis products becomes increasingly important to ensure manufacturing efficiency, reproducibility, and product quality.
Cryoport, a global leader in temperature-controlled supply chain and cryopreservation solutions for the cell and gene therapy industry, recently collaborated with bioMérieux's ACCELLIX™ team to evaluate the use of the ACCELLIX™ automated flow cytometry within their cryopreservation workflow.
The study, presented at ISCT 2026, assessed how ACCELLIX™ compares with conventional flow cytometry while supporting a more standardized and scalable manufacturing approach.
Standardizing Cell Characterization Across Sites
For organizations operating across multiple manufacturing and processing locations, standardization is critical. One of the key challenges that Dominic Clarke, VP of Technical Operations at Cryoport, notes is that a lot of processes are manual, leading to uncontrolled variability.
Cryoport's IntegriCell platform was designed to bring consistency to leukapheresis cryopreservation. ACCELLIX™ complements that approach by extending standardization of the cellular characterization using flow cytometry testing.
“ACCELLIX™ came into play as a nice complement to the solution we're providing, helping address an area where standardization has traditionally been difficult.”
Simplifying Testing Workflow with Automated Flow Cytometry
Traditional flow cytometry remains the gold standard for cell characterization, but it often requires highly trained personnel, complex workflows, and significant hands-on time.
Through their experience, the Cryoport team highlighted how the ACCELLIX™ workflow simplifies testing through an automated cartridge-based approach.
“It's a simple process: collect, add to the reagent, put it on the cartridge, put it in the machine, push a button, and walk away.”
By reducing manual intervention, laboratories can minimize operator-dependent variability while supporting GMP manufacturing requirements.
Delivering Fast and Reliable Results
In cell therapy manufacturing, actionable data is often needed in real time.
Cryoport evaluated ACCELLIX™ at multiple workflow checkpoints, including incoming leukapheresis material, in-process controls, and final formulation – all with the conclusion that ACCELLIX™ provided rapid access to results and enabled testing at process stages where conventional flow cytometry was difficult to perform within operational time constraints.
Not only did ACCELLIX™ provide fast results, but it also proved to bring minimal inter-assay variability and maintained characterization of key cell populations throughout processing and cryopreservation.
“The key finding was that the ACCELLIX™ platform delivered results comparable to conventional flow cytometry, with minimal bias and significantly faster turnaround times.”
Fig. 1: Comparison across processing steps and platforms
By helping reduce operator variability, accelerate turnaround times, and standardize testing across sites, ACCELLIX™ supports the Cell and Gene therapy industry's move toward more robust and decentralized manufacturing models.
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