ISO 21709:2020

INTERNATIONAL ISO
STANDARD 21709
First edition
2020-11
Biotechnology — Biobanking —
Process and quality requirements
for establishment, maintenance and
characterization of mammalian cell
lines
Biotechnologie — Biobanking — Exigences de processus et de qualité
pour la génération, le maintien et la caractérisation des lignées
cellulaires de mammifères
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General . 3
4.2 Legal and ethical requirements . 3
4.3 Facilities . 4
4.3.1 General. 4
4.3.2 Cell culture facility . 4
4.4 Equipment . 4
4.4.1 General. 4
4.4.2 Equipment inspection . 5
4.5 Reagents. 6
4.6 Informed consent . 6
4.6.1 General. 6
4.6.2 Procedure of obtaining informed consent . 6
4.6.3 Special circumstances for informed consent . 7
4.6.4 Information provided to the donor/patient or the donor's/patient’s
legally designated or nominated representative . 7
4.6.5 Informed consent signature . 8
4.7 Personnel . 8
4.7.1 General. 8
4.7.2 Personnel competence . . 9
4.7.3 Personnel training . 9
4.7.4 Biorisk and biosafety of personnel . 9
5 Process requirements . 9
5.1 Establishment of cell lines within the biobank . 9
5.1.1 General. 9
5.1.2 Isolation and purification of primary cells .10
5.1.3 Primary cultures .10
5.1.4 Cell lines .11
5.2 Reception of established cell lines .11
5.2.1 General.11
5.2.2 Review of the deposit request .11
5.2.3 Decision on the deposit request .12
5.2.4 Transfer of material and associated data .12
5.2.5 Characterization and authentication of the cell line .13
5.2.6 Assignment of accession number .13
5.3 Cell line management .14
5.3.1 Planning for cell banking .14
5.3.2 Accession .14
5.3.3 Propagation of cell lines .14
5.3.4 Preservation and storage .15
5.3.5 Inventory management .15
5.3.6 Disposal management .15
5.4 Distribution .16
5.4.1 General.16
5.4.2 Acceptance of order request .16
5.4.3 Distribution review .16
5.4.4 Transport .16
5.5 Quality control, validation and verification .17
5.5.1 Quality control .17
5.5.2 Validation and verification .17
6 Performance evaluation and improvement .17
Annex A (informative) Recommended units for biobanking of cell lines .19
Bibliography .20
iv © ISO 2020 – All rights reserved

Foreword
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This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
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Introduction
Scientific research using cell lines has contributed greatly to the understanding of human health. Cell
cultures are increasingly used to complement studies using animal models. Although cell lines are
important research tools, potential problems have recently been identified.
Cell lines have unique characteristics and behaviour that can change as they continue to be passaged.
The original phenotype (e.g. expression of specific biomarkers) can be lost or new characteristics or
behaviour (e.g. development of tumorigenicity) may develop. It is important to minimize passaging to
retain the original characteristics that were present when
...