{"entity":{"id":"idea-reg-cart-potency-reference-standards","kind":"idea","name":"Public reference standards and potency assays for CAR-T so every lab measures alike","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"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)","url":"https://doi.org/10.1001/jamaoncol.2018.0977"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["car-t"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-reproducibility"],"keyPapers":["paper-hernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"medium","horizonYears":3},"route":"/ideas/idea-reg-cart-potency-reference-standards/","neighbours":{"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"}],"paper":[{"id":"paper-hernandez-jama-oncol","kind":"paper","name":"Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy","route":"/key-papers/paper-hernandez-jama-oncol/"}]}}