{"entity":{"id":"cell-therapy-release-testing","kind":"technology","name":"Cell-therapy release and potency testing","aka":[],"tldr":"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.","status":"established","asOf":"2026-09-08","links":[{"label":"FDA guidance: potency assurance for cellular and gene therapy products","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["cell-therapy"],"technologies":["car-t","closed-automated-cell-manufacturing","flow-cytometry-mrd"],"targets":[],"drugs":[],"companies":["charles-river","becton-dickinson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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"]},"route":"/technologies/cell-therapy-release-testing/","neighbours":{"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"}],"technology":[{"id":"allogeneic-cell-therapy","kind":"technology","name":"Allogeneic (off-the-shelf) cell therapy","route":"/technologies/allogeneic-cell-therapy/"},{"id":"allogeneic-cell-banks","kind":"technology","name":"Allogeneic cell banks: one donor, hundreds of doses","route":"/technologies/allogeneic-cell-banks/"},{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"car-nk-macrophage","kind":"technology","name":"CAR-NK & CAR-macrophage","route":"/technologies/car-nk-macrophage/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"closed-automated-cell-manufacturing","kind":"technology","name":"Closed automated cell-therapy manufacturing","route":"/technologies/closed-automated-cell-manufacturing/"},{"id":"dendritic-cell-vaccines","kind":"technology","name":"Dendritic cell vaccines","route":"/technologies/dendritic-cell-vaccines/"},{"id":"pharmaceutical-gmp-inspections","kind":"technology","name":"GMP, inspections, Form 483s and warning letters","route":"/technologies/pharmaceutical-gmp-inspections/"},{"id":"flow-cytometry-mrd","kind":"technology","name":"Multiparameter flow cytometry MRD","route":"/technologies/flow-cytometry-mrd/"},{"id":"nk-cell-therapy","kind":"technology","name":"NK cell therapy and CAR-NK","route":"/technologies/nk-cell-therapy/"},{"id":"tcr-t","kind":"technology","name":"TCR-T cell therapy","route":"/technologies/tcr-t/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}],"company":[{"id":"becton-dickinson","kind":"company","name":"BD (Becton, Dickinson and Company)","route":"/companies/becton-dickinson/"},{"id":"charles-river","kind":"company","name":"Charles River Laboratories","route":"/companies/charles-river/"}]}}