ISO/TS 23511:2023
Biotechnology — General requirements and considerations for cell line authentication
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles of cell line authentication
4.1 General
4.2 Confirmation of cell origin
4.3 Detection of cross-contamination
4.3.1 Detection of cell line inter-species cross-contamination
4.3.2 Detection of cell line intra-species cross-contamination
4.4 Identification of cell line-specific characteristics
4.4.1 Detection of cell line genome heterogeneity
4.4.2 Detection of cellular differentiation
5 Application scenarios of cell line authentication
6 Sample preparation
7 Method options for cell line authentication
7.1 General
7.2 DNA-based cell line authentication methods
7.2.1 Short tandem repeat profiling
7.2.2 Single nucleotide polymorphism profiling
7.2.3 DNA barcoding
7.2.4 Multiplex PCR
7.2.5 Whole genome sequencing
7.3 Related methods for cell line identification
8 Authentication method selection
8.1 General
8.2 Cell origin
8.2.1 Confirmation of cell line origin
8.2.2 Identification of cell line gene mutations
8.2.3 Identification of cell line-specific properties
8.3 Species types of cross-contamination
8.3.1 Cell line inter-species cross-contamination
8.3.2 Cell line intra-species cross-contamination
8.4 Cell culture methods
8.4.1 Authentication for co-cultured cells
8.4.2 Authentication for ex vivo cell culture
8.4.3 Authentication for laboratory operation
8.5 Authentication purpose
9 Quality control
9.1 Operator training
9.2 Instruments and equipment
9.3 Reagents
9.4 Validation and verification of methods
9.4.1 General
9.4.2 Validation
9.4.3 Verification
10 Report
10.1 Reporting
10.2 Evaluation of measurement uncertainty
Annex A (informative) Detection methods for cell line authentication
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles of cell line authentication
4.1 General
4.2 Confirmation of cell origin
4.3 Detection of cross-contamination
4.3.1 Detection of cell line inter-species cross-contamination
4.3.2 Detection of cell line intra-species cross-contamination
4.4 Identification of cell line-specific characteristics
4.4.1 Detection of cell line genome heterogeneity
4.4.2 Detection of cellular differentiation
5 Application scenarios of cell line authentication
6 Sample preparation
7 Method options for cell line authentication
7.1 General
7.2 DNA-based cell line authentication methods
7.2.1 Short tandem repeat profiling
7.2.2 Single nucleotide polymorphism profiling
7.2.3 DNA barcoding
7.2.4 Multiplex PCR
7.2.5 Whole genome sequencing
7.3 Related methods for cell line identification
8 Authentication method selection
8.1 General
8.2 Cell origin
8.2.1 Confirmation of cell line origin
8.2.2 Identification of cell line gene mutations
8.2.3 Identification of cell line-specific properties
8.3 Species types of cross-contamination
8.3.1 Cell line inter-species cross-contamination
8.3.2 Cell line intra-species cross-contamination
8.4 Cell culture methods
8.4.1 Authentication for co-cultured cells
8.4.2 Authentication for ex vivo cell culture
8.4.3 Authentication for laboratory operation
8.5 Authentication purpose
9 Quality control
9.1 Operator training
9.2 Instruments and equipment
9.3 Reagents
9.4 Validation and verification of methods
9.4.1 General
9.4.2 Validation
9.4.3 Verification
10 Report
10.1 Reporting
10.2 Evaluation of measurement uncertainty
Annex A (informative) Detection methods for cell line authentication
Bibliography