International Standard
ISO/TS 23511:2023
Biotechnology — General requirements and considerations for cell line authentication
Reference number
ISO/TS 23511:2023
Edición 1
2023-05
International Standard
Vista previa
ISO/TS 23511:2023
75854
No disponible en español
Publicado (Edición 1, 2023)

ISO/TS 23511:2023

ISO/TS 23511:2023
75854
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CHF 96
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Resumen

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).

Informaciones generales

  •  : Publicado
     : 2023-05
    : Norma Internacional para revisar [90.92]
  •  : 1
     : 18
  • ISO/TC 276
    07.080 
  • RSS actualizaciones

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