Evidence map›Paper›PMID 37736833›Full record

ArticleJournal of fluorescence2024

Practical Characterization Strategies for Comparison, Qualification, and Selection of Cell Viability Detection Methods for Cellular Therapeutic Product Development and Manufacturing.

Yongyang Huang, Rachel Watkins, Samir Patel, Mackenzie Pierce, Carolina Franco Nitta, Henry Qazi, William L Rice, Bo Lin, Chris Lowe, Carlos le Sage and 1 more

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Journal of fluorescence, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yongyang HuangRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA. yongyang.huang@revvity.com.
Rachel WatkinsHorizon Discovery Ltd., Cambridge, CB25 9TL, UK.
Samir PatelRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
Mackenzie PierceRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
Carolina Franco NittaRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
Henry QaziRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
William L RiceRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
Bo LinRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.
Chris LoweHorizon Discovery Ltd., Cambridge, CB25 9TL, UK.
Carlos le SageHorizon Discovery Ltd., Cambridge, CB25 9TL, UK.
Leo Li-Ying ChanRevvity Health Sciences, Inc., 360 Merrimack St., Suite 200, Lawrence, MA, 01843, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cellular therapy development and manufacturing has focused on providing novel therapeutic cell-based products for various diseases. The International Organization for Standardization (ISO) has provided guidance on critical quality attributes (CQAs) that shall be considered when testing and releasing cellular therapeutic products. Cell count and viability measurements are two of the CQAs that are determined during development, manufacturing, testing, and product release. The ISO Cell Counting Standard Part 1 and 2 addressed the needs for improving the quality of cell counting results. However, there is currently no guidance on the qualification and selection of a fit-for-purpose cell viability detection method. In this work, we present strategies for the characterization and comparison of AO/PI and AO/DAPI staining methods using the heat-killed (HK) and low temperature/nutrient-deprived (LT/ND) cell death models to evaluate the comparability of cell viability measurements and identify potential causes of differences. We compared the AO/PI and AO/DAPI staining methods using HK and LT/ND-generated dead cells, investigated the staining time effects on cell viability measurements, and determined their viability linearity with different mixtures of live and dead cells. Furthermore, we validated AO/PI and AO/DAPI cell viability measurement with a long-term cell proliferation assay. Finally, we demonstrate a practical example of cell viability measurement comparison using AO/PI and AO/DAPI on antibiotic-selected transduced Jurkat and THP-1 cells to select a fit-for-purpose method for functional genomics screening. The proposed strategies may potentially enable scientists to properly characterize, compare, and select cell viability detection methods that are critical for cellular therapeutic product development and manufacturing.

Indexed as

Cell SurvivalCell- and Tissue-Based TherapyCell ProliferationHumansStaining and Labeling4′,6-diamidino-2-phenylindole (DAPI)Acridine orangeCell therapyCell viabilityHigh-throughput cell counterImage cytometryPropidium iodide

Identifiers

PMID37736833

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.