Cell & Gene Therapy Resources

A practical one-page scoring tool to evaluate cell counters against 21 CFR Part 11.

The compliance explainer: what 21 CFR Part 11 actually demands of a cell counter — audit trail, e-signature, access control, and a Secure Mode.

An educational field guide to the audit-ready framing and the five requirements of a count you can defend.

A demand-creation reframe: in GMP cell therapy, the cell count can function as a release assay — and what that shift means for how you count and prove it.

The evergreen guide to what makes a GMP cell-therapy count audit-ready — the hub for the Part 11 and volumetric-vs-image explainers.

The method explainer: volumetric vs image-based counting for CAR-T QC, and why the CV gap matters at lot release.

Peer-reviewed concordance data showing the Moxi GO II consolidates cell counting, sizing, viability, and 2-color immunophenotyping into a single 15-second, at-bench measurement for CAR-T expansion monitoring — replacing the standard two-instrument core-lab workflow. In a University of Pennsylvania study (Pajarillo et al., Cytotherapy 2024), the Moxi GO II matched gold-standard reference instruments for viability (r² = 0.97), CD4+ T cell identification (r² = 0.997), and CAR19 transduction efficiency (r² = 0.90), eliminating the 3–6 hour turnaround for routine expansion checkpoints. For Research Use Only.

The authors used a Moxi GO II to count and monitor CAR T cells (including cell size/growth kinetics) throughout expansion, advancing the products into in vitro cytotoxicity assays and in vivo PTCL PDX studies only once the cells’ kinetics/size indicated they had “rested” from stimulation.

The authors used a Moxi GO II to count engineered T-cell cultures every other day and monitor cell size/growth kinetics as a practical criterion for when the cells had rested from stimulation and were ready to proceed into downstream adoptive T-cell experiments.

Scientists are concerned with speed, accuracy, and convenience, and those running the lab and industries are concerned with the cost typically associated with high-performing instruments. Our proprietary Coulter Principle-based system delivers on all three accounts, and is therefore a perfect fit for any cell biology benchtop.

There are a variety of ways to monitor this process in cell culture, the two most prominent being cell counting via imaging-based and coulter-based cell counting methods and higher-level cellular analysis with fluorophore-tagged antibodies and fluorescent reporters via flow cytometry. While each instrument used to achieve these two things has its advantages and disadvantages, few and far between can do both at once. Out of all your options, no other instrument has the power to do both with the speed, precision, and ease that Precision Cell Systems' Moxi Go II can. In this document, we will take you through how you can unlock the next stage in your cellular analysis process for CAR-T with our instruments.