Status : Published (To be revised)

This standard will be replaced by ISO/CD 23511
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Abstract

This document defines terms related to cell line authentication in the field of biotechnology. It describes the general principles, detection strategies and analytical methods for cell line authentication. It specifies requirements and key considerations for method selection, quality control parameters, data analysis and reporting.

This document is applicable to routine inspection of cell lines in culture and in storage in the fields of basic research, translational studies and product manufacturing. It is also applicable to cell line origin validation in academic and industrial laboratories, cell banks and manufacturing sites. It is primarily applicable to mammalian cells, including human cells.

This document does not apply to non-animal cells (e.g. microbial contamination, plant cells), nor to cells in complex matrices (e.g. tissues, organs, organoids, plants).

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General information

  • Status
     : Published
    Publication date
     : 2023-05
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 1
    Number of pages
     : 18
  • Technical Committee :
    ISO/TC 276
    ICS :
    07.080 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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