# Public reference standards and potency assays for CAR-T so every lab measures alike

Source: https://onco.cc/ideas/idea-reg-cart-potency-reference-standards/  
OnCo record `idea-reg-cart-potency-reference-standards` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

There is no agreed ruler for measuring how strong a CAR-T product is. Shared reference materials would let hospitals, companies and regulators compare products fairly.

## Summary

How strongly a CAR-T batch kills its target cells is the release attribute regulators worry about most for cell therapies, and every developer measures it with a different in-house assay, making comparability, decentralised manufacturing and biosimilar-like competition impossible. The proposal is a programme, led by a metrology institute such as NIST or NIBSC with the ISCT and regulators, to produce certified reference CAR-T cell materials, reference target cells and standardised cytotoxicity and cytokine assays with published acceptance criteria, made available at cost.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Adoption of reference standards reduces inter-laboratory coefficient of variation in CAR-T potency measurement from above 40% to below 15% and is accepted by FDA and EMA as the basis for site-to-site comparability without clinical bridging.
- Rationale: Reference standards underpinned the biosimilar revolution and the standardisation of flow cytometry for CD34 counting. Cell-therapy potency is technically harder but not different in kind.
- Proposed test: Produce pilot reference materials, run an international ring trial across 20 laboratories, and publish variance before and after standardised protocols.
- Maturity: early-clinical
- Actor: research

## Sources

- Bottleneck evidence (Manufacturing cost and time for living and radioactive medicines): Hernandez, Prasad & Gellad, Total costs of chimeric antigen receptor T-cell immunotherapy (JAMA Oncology 2018): https://doi.org/10.1001/jamaoncol.2018.0977

## Connected records

- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/)
- key papers: [Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy](https://onco.cc/key-papers/paper-hernandez-jama-oncol/)

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