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Product Product ISO/TS 23511:2023
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Description Description

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).

Standard Number Standard Number ISO/TS 23511:2023
Title Title ISO/TS 23511:2023 Biotechnology — General requirements and considerations for cell line authentication
Status Status Published
Publication Date Publication Date 20 Jun 2023
Cross References Cross References
Descriptors Descriptors
ICS ICS 07.080
Committee Committee ISO/TC 276 Biotechnology
ISBN ISBN
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 18
File Size File Size KB