Officials at Cellares say the Integrated Development and Manufacturing Organization (IDMO) entered multiple strategic technology partnerships to advance the Cell Q™, a fully automated quality control testing platform purpose-built to match the commercial-scale throughput for cell therapy manufacturing.
Cellares is unveiling these partnerships ahead of the 10th Annual CAR-TCR Summit, where it will, for the first time, present drug product release data automatically generated on the Cell Q and case studies highlighting the automation of system verification, thawing, assay preparation, and execution of vector copy number (VCN) quantification.
Cell Q is the first of its kind, i.e., a modular, highly configurable QC platform that automates and streamlines labor-intensive, error-prone in-process and release assays, according to Fabian Gerlinghaus, CEO and co-founder of Cellares. While traditional manual QC infrastructure will struggle to keep pace, a single Cell Q system can support automated QC release testing of up to 6,000 cell therapy batches per year, unlocking true end-to-end scalability, he continues.
Working with technology providers like Tecan, Advanced Instruments, Cytek Biosciences, Slingshot Biosciences, and AltemisLab, Cell Q “streamlines” all critical QC testing operations, from high-throughput sample preparation to real-time data tracking and reporting, claims Gerlinghaus.
New standard for QC automation
Gerlinghaus says Cellares drove product development and integration of best-in-class technology providers across five key domains—liquid handling, liquid property characterization, flow cytometry, synthetic controls, and sample tracking—to co-develop specialized hardware, software, and reagents designed to integrate seamlessly into the Cell Q platform:
- Tecan: Delivered advanced liquid handling systems and hardware-software interfaces to enable scalable, reproducible workflows and results.
- Advanced Instruments: Integrated and automated verification of liquid handling, performance, and calibration with its Artel® portfolio.
- Cytek Biosciences: Optimized fully automated full spectrum flow cytometry workflows, from plate mapping through takedown.
- Slingshot Biosciences: Developed cell mimics and ready-to-use flow cytometry panels that enable reproducible results across sites, operators, and instruments.
- AltemisLab: Integrated pre-barcoded cryovials, tube decapping, and automated thawing to preserve Chain of Identity (COI) and Chain of Custody (COC) across the QC lifecycle.
As regulators raise expectations for data integrity, method validation, and lifecycle management, a spokesperson for Cellares explained that Cell Q provides a ready-made infrastructure to support GMP compliance, digital traceability, and audit-readiness from day one. For early-stage developers, this helps de-risk tech transfer and can accelerate IND timelines, while for commercial developers, it can reduce labor dependency and batch failure risk while enabling global scaleup, the spokesperson points out.
“Cell Q was built to match the commercial manufacturing throughput of the Cell Shuttle,” stated Gerlinghaus, “with fewer handoffs, less failure, and more importantly, better data quality.”
At the upcoming 10th Annual CAR-TCR Summit, John Cesarek, Cellares’ senior director of automation, will present “From Bottlenecks to Breakthroughs: Automating Commercial-Scale QC Testing with Cell Q” on Thursday, September 25 at 2:15 PM ET.