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Cell viability testing is a fundamental quality control service for mammalian cell bank (MCB/WCB) release. It accurately measures the percentage of live cells in a population, serving as a core indicator of membrane integrity, metabolic activity, and proliferative potential.
Viability testing is a mandatory release parameter. It directly reflects the effectiveness of freezing and thawing processes and is required at multiple time points: MCB banking, WCB banking, and stability studies. We offer two complementary methods – Trypan blue dye exclusion (manual or automated) and flow cytometry (PI/7-AAD) – designed to align with USPANDA guidance.
Trypan blue is a membrane-impermeable dye. Live cells with intact membranes exclude the dye and remain clear; dead cells with damaged membranes take up the dye and appear blue. Detection is performed by microscope or automated cell counters (Vi-CELL, Countess).
Fluorescent dyes (PI, 7-AAD, AO/PI) specifically label dead cells. Individual cells are analyzed at high speed using laser excitation and fluorescence detection. Flow cytometry can also distinguish apoptotic and necrotic cells (e.g., Annexin V/PI dual staining). Recommended by NMPA for CAR-T product release.
| Guideline | Key Requirement |
| USPANDA | Provides a framework for cell counting and viability method validation. |
| ICH Q5C | Viability is a key parameter in stability studies for cell therapy products. |
| USPANDA | For cell/gene therapy products, the FDA suggests viability >70%, EMA >80%. |
| Cell Bank Type | Requirement |
| MCB | Must test post-banking viability as baseline |
| WCB | Must test; verify consistency with MCB |
| Stability studies | Must test at multiple timepoints |
| EOPC | Must test; compare to MCB for production stability |
For a customized cell viability testing strategy, method validation, or IND/BLA submission support, contact Creative Biogene's technical team.
Q: How to choose between Trypan blue and flow cytometry?
A: Trypan blue is simple, low-cost, and suitable for routine MCB/WCB release and process control. Flow cytometry offers higher sensitivity, multiplexing (apoptosis, surface markers), and is recommended for CAR-T and cell therapy product release per NMPA guidance. We can recommend the optimal method based on your product stage.
Q: Why is viability testing mandatory for cell bank release?
A: Viability directly reflects freezing/thawing process effectiveness. Low viability indicates poor banking process and may compromise subsequent production (proliferation, gene expression, protein yield). It is a basic release parameter for MCB and WCB.
Q: Can the test report be used for US or EU submissions?
A: Yes. Our protocols align with USPANDA and ICH Q5C. Report formats support regulatory frameworks for major authorities. Contact us for submission strategy.
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