Cell Viability
يعرف أيضا باسم: 세포 생존율
Cell viability is the proportion of living, functional cells in a sample; it is a key quality measure for cell preparations such as SVF before and after processing or freezing.
What is an acceptable cell viability for cell therapy products?
For cell therapy products, the FDA generally expects a minimum viability specification above 70%, and sponsors must justify a lower limit with data [2]. NK-cell trials in the US and Europe used ≥70% across the board [4]. Some products use stricter limits. The commercial specification for the CAR T product tisagenlecleucel is at least 80%, although a 2019 analysis found no link between viability below 80% and remission rates [3].
حقائق أساسية
| المحمول | القيمة | المصدر |
|---|---|---|
| Definition of a viable cell | A cell with an intact membrane or the capacity for metabolism, motility, proliferation or response to stimuliحتى تاريخ 19 يناير 2022 | [1]journalQuantitative, traceable determination of cell viability using absorbance microscopyPLoS One |
| Dye-exclusion principle | Trypan blue enters cells with damaged membranes and stains them blue; unstained cells are counted as viableحتى تاريخ 19 يناير 2022 | [1]journalQuantitative, traceable determination of cell viability using absorbance microscopyPLoS One |
| Common plate-reader assay classes | Tetrazolium reduction (MTT, MTS, XTT, WST-1), resazurin reduction, protease substrate (GF-AFC), ATP luciferase and real-time luminescent assaysحتى تاريخ 1 يوليو 2016 | [2]journalCell Viability Assays (Assay Guidance Manual)National Center for Biotechnology Information (NCBI Bookshelf), Riss TL et al. |
| Typical research uses | Measuring cell proliferation, testing compounds for cytotoxic effects, and as an internal control for viable cell number in multiplexed assaysحتى تاريخ 1 يوليو 2016 | [2]journalCell Viability Assays (Assay Guidance Manual)National Center for Biotechnology Information (NCBI Bookshelf), Riss TL et al. |
| ATP assay characteristics | Described as the fastest and most sensitive viability assay and less prone to artifacts, but it is an endpoint assay that lyses cellsحتى تاريخ 1 يوليو 2016 | [2]journalCell Viability Assays (Assay Guidance Manual)National Center for Biotechnology Information (NCBI Bookshelf), Riss TL et al. |
| Trypan blue measurement variability | Image-based trypan blue scoring depends on microscope optics, cameras and settings; heat-killed cells took up about 50% more dye than formaldehyde-fixed cells in a NIST studyحتى تاريخ 19 يناير 2022 | [1]journalQuantitative, traceable determination of cell viability using absorbance microscopyPLoS One |
| Related standard | ISO 20391 (Biotechnology — Cell counting), cited in NIST work on traceable viability measurementحتى تاريخ 19 يناير 2022 | [1]journalQuantitative, traceable determination of cell viability using absorbance microscopyPLoS One |
| CAR T (CTL019) viability release specification | At least 80% for the commercial product; early clinical trials used at least 70% %حتى تاريخ 1 يناير 2019 | [3]journalCAR T cell viability release testing and clinical outcomes: is there a lower limit?Blood (Chong EA et al.), 134(21):1873–1875 |
| Viability and clinical outcome (CAR T) | No link was found between product viability below 80% and response, expansion or survival in 123 pediatric ALL and 25 adult DLBCL patientsحتى تاريخ 1 يناير 2019 | [3]journalCAR T cell viability release testing and clinical outcomes: is there a lower limit?Blood (Chong EA et al.), 134(21):1873–1875 |
| NK cell therapy viability acceptance range | ≥70% in all reviewed Phase 1/2 trials; assay protocols were not harmonized across trials %حتى تاريخ 11 نوفمبر 2025 | [4]journalQuality standards for NK cell immunotherapiesFrontiers in Bioengineering and Biotechnology (von Werz et al.) |
نظرة عامة
Cell viability is the number or proportion of living cells in a sample. It is usually reported as percent viable cells or as viable cells per unit volume. Because 'viable' is defined by what a test measures (an intact membrane, or functions such as metabolism or proliferation), results depend on the assay used. Dye-exclusion methods, such as trypan blue or fluorescent dyes read by automated counters, check whether the cell membrane is intact. Plate-based assays measure tetrazolium or resazurin reduction, protease activity or ATP. Viability is used in cytotoxicity testing, cell culture, cryopreservation research and as a release criterion for cell therapy products, where clinical trials have commonly used thresholds of 70–80%. ISO 20391 covers cell counting methods. Readers should check which assay, instrument and definition a reported figure is based on.
المراجع
نسبة المصادر المستقلة 100% (4/4)- المستوى B · journalQuantitative, traceable determination of cell viability using absorbance microscopy — PLoS One · تاريخ الاطلاع 11 نوفمبر 2026 · صفحة الدليل
- المستوى B · journalCell Viability Assays (Assay Guidance Manual) — National Center for Biotechnology Information (NCBI Bookshelf), Riss TL et al. · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل
- المستوى B · journalCAR T cell viability release testing and clinical outcomes: is there a lower limit? — Blood (Chong EA et al.), 134(21):1873–1875 · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل
- المستوى B · journalQuality standards for NK cell immunotherapies — Frontiers in Bioengineering and Biotechnology (von Werz et al.) · تاريخ الاطلاع 10 نوفمبر 2026 · صفحة الدليل