Cell-therapy release and potency testing
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.
How it works
Compendial and validated assays performed on samples of the final product, with defined acceptance criteria in the marketing authorisation.
- Patient safety
- Regulatory clarity
- Adds days to delivery
- Potency assays poorly predictive of clinical activity
- Sample volume consumes product
Latest papers
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