# Cell-therapy release and potency testing

Source: https://onco.cc/technologies/cell-therapy-release-testing/  
OnCo record `cell-therapy-release-testing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The quality checks a CAR-T batch must pass before it can be given: sterile, correct identity, enough live CAR-positive cells, and no replicating virus.

## Summary

Release panels include sterility (rapid methods such as BacT/ALERT cut 14 days to about 7), mycoplasma PCR, endotoxin, identity (HLA), viability and CAR expression by flow cytometry, vector copy number by qPCR, replication-competent lentivirus, and potency (cytokine release or cytotoxicity). Testing time is a large share of vein-to-vein time; rapid and in-line methods and reduced-testing strategies for early-phase products are active regulatory topics.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-09-08
- Tags: supporting
- Principle: Compendial and validated assays performed on samples of the final product, with defined acceptance criteria in the marketing authorisation.
- Strengths: Patient safety; Regulatory clarity
- Limitations: Adds days to delivery; Potency assays poorly predictive of clinical activity; Sample volume consumes product

## Sources

- FDA guidance: potency assurance for cellular and gene therapy products: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [Allogeneic (off-the-shelf) cell therapy](https://onco.cc/technologies/allogeneic-cell-therapy/), [Allogeneic cell banks: one donor, hundreds of doses](https://onco.cc/technologies/allogeneic-cell-banks/), [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-NK & CAR-macrophage](https://onco.cc/technologies/car-nk-macrophage/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Closed automated cell-therapy manufacturing](https://onco.cc/technologies/closed-automated-cell-manufacturing/), [Dendritic cell vaccines](https://onco.cc/technologies/dendritic-cell-vaccines/), [GMP, inspections, Form 483s and warning letters](https://onco.cc/technologies/pharmaceutical-gmp-inspections/), [Multiparameter flow cytometry MRD](https://onco.cc/technologies/flow-cytometry-mrd/), [NK cell therapy and CAR-NK](https://onco.cc/technologies/nk-cell-therapy/), [TCR-T cell therapy](https://onco.cc/technologies/tcr-t/), [TIL therapy](https://onco.cc/technologies/til-therapy/)
- companies: [BD (Becton, Dickinson and Company)](https://onco.cc/companies/becton-dickinson/), [Charles River Laboratories](https://onco.cc/companies/charles-river/)

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