ISO/TS 23511:2023

Indisponible en français

Publiée (Edition 1, 2023)

ISO/TS 23511:2023

CHF 96

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Résumé

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).

Informations générales

État actuel
: Publiée

Date de publication
: 2023-05

Stade
: Norme internationale à réviser [90.92]
Edition
: 1
Comité technique :
ISO/TC 276

ICS :
07.080
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