Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features

This document provides general requirements for cell morphometry to quantify cell morphological features including cell shape, size and texture. This document addresses aspects of cell image capture using optical microscopy and image processing for morphometry. This document does not address the statistics associated with a morphological analysis of a cellular sample. This document also gives terms and definitions corresponding to cell morphological descriptors, and lists examples and their formulae, that represent quantitative cellular morphological features for evaluation of cell morphology in cell analysis. This document primarily applies to morphological analysis of cultured mammalian cells. This document is not intended for imaging used in clinical diagnostics.

Biotechnologie — Analyse morphologique cellulaire — Exigences générales et considérations pour la morphométrie cellulaire afin de quantifier les caractéristiques morphologiques des cellules

General Information

Status
Published
Publication Date
16-Oct-2024
Current Stage
6060 - International Standard published
Start Date
17-Oct-2024
Due Date
22-Oct-2024
Completion Date
17-Oct-2024
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ISO 24479:2024 - Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features Released:17. 10. 2024
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International
Standard
ISO 24479
First edition
Biotechnology — Cellular
2024-10
morphological analysis — General
requirements and considerations
for cell morphometry to quantify
cell morphological features
Biotechnologie — Analyse morphologique cellulaire — Exigences
générales et considérations pour la morphométrie cellulaire afin
de quantifier les caractéristiques morphologiques des cellules
Reference number
© ISO 2024
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ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 4
5 General Concept . 5
5.1 Cell morphometry .5
5.2 Steps for cell morphometry .5
6 Target of interest (TOI) . 5
7 Image capture . 6
7.1 Microscopic observation method . .6
7.1.1 General .6
7.1.2 Cell properties to be observed .7
7.1.3 Sample preparation .7
7.2 Microscope system and its settings .9
7.2.1 General .9
7.2.2 Light source .11
7.2.3 Objective lens and condenser lens .11
7.2.4 Components in optical path .11
7.2.5 Image capture device . 12
7.2.6 Image data . 12
7.2.7 Environmental conditions . 12
7.2.8 Observing position . 12
7.2.9 Image capturing conditions . 13
7.3 Execution of image capture . 13
7.3.1 Single image capture. 13
7.3.2 Multiple image capture . 13
8 Segmentation of the TOI .13
9 Quantification . 14
9.1 General .14
9.2 Procedure to quantify morphological features of segmented object .14
10 Qualification of Measurement . 14
11 Reporting .15
11.1 General . 15
11.2 Reporting of sample properties and sample preparation . 15
11.3 Reporting of the microscopic observation method . 15
11.4 Reporting of the image data, image pre-processing, and image analysis for
morphometric analysis .16
11.5 Reporting of the morphological features for morphometric analysis .17
Annex A (informative) Check sheet regarding selection of contrast-enhancing techniques for
optical microscopy .18
Annex B (informative) Check sheet regarding selection of microscope system .20
Annex C (informative) List of cell morphological descriptors, definitions and formulae for cell
shape, size .21
Annex D (informative) List of cell morphological descriptors, definitions and formulae for cell
texture .29

iii
Annex E (informative) Points to consider when acquiring phase-contrast images of cells
suitable for image analysis .34
Bibliography .43

iv
Foreword
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This document was prepared by Technical Committee ISO/TC 276, Biotechnology, Subcommittee SC 1,
Analytical methods.
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v
Introduction
Optical microscopy is a widely practiced technique for characterization of processed cells. Morphology of
cells, such as shape, size, texture of whole or parts of cells, can provide information about various aspects of
cells including identity, phenotype, viability, doubling time, as well as the states of stress and drug responses.
Morphological evaluation of cells is widely employed in basic research, drug discovery, in-process control
and release testing for cell manufacturing and cell banks for cell-based therapeutic products.
Therefore, it is desired to establish a common understanding of definitions and formulae regarding cell
morphological descriptors in which specialists in research and business fields can refer to and compare
information, within an institution, and with other interested parties.
The current situation is that characteristics of cell morphology obtained from microscopic images are
frequently described qualitatively in expressions such as "unevenness around", "elongated", "rounded". Even
when cell morphological descriptors characterizing the morphology of the cell are measured and quantified
from the cell image, these cell morphological descriptors are not consistently used.
This document allows to check whether the numerical values
...

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