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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.
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.
Compendial and validated assays performed on samples of the final product, with defined acceptance criteria in the marketing authorisation.
Nothing recorded yet: a foundation, or a gap to fill.
Dependencies are what this technology cannot be delivered without: manufacturing steps, instruments, software, upstream methods. See its full chain on the map.
Query for this technology: (TITLE:"Cell-therapy release and potency testing" OR ABSTRACT:"Cell-therapy release and potency testing") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cell-therapy release and potency testing, not a curated reading list.
Shares NK cell therapy and CAR-NK, Allogeneic cell banks: one donor, hundreds of doses, Autologous CAR-T manufacturing, batch by batch, TIL therapy and the tag supporting.
Shares Charles River Laboratories, Allogeneic cell banks: one donor, hundreds of doses, Autologous CAR-T manufacturing, batch by batch, CAR-NK & CAR-macrophage and the tag supporting.
Shares Dendritic cell vaccines, Autologous CAR-T manufacturing, batch by batch, TCR-T cell therapy, CAR-T cell therapy and the tag supporting.
Shares Closed automated cell-therapy manufacturing, Autologous CAR-T manufacturing, batch by batch and the tag supporting.
Shares Closed automated cell-therapy manufacturing, Autologous CAR-T manufacturing, batch by batch and the tag supporting.
Shares CAR-NK & CAR-macrophage, Allogeneic (off-the-shelf) cell therapy, CAR-T cell therapy and the tag supporting.
Shares Closed automated cell-therapy manufacturing, Autologous CAR-T manufacturing, batch by batch and the tag supporting.
Shares Closed automated cell-therapy manufacturing, GMP, inspections, Form 483s and warning letters, Autologous CAR-T manufacturing, batch by batch and the tag supporting.