ISO 24603:2022

INTERNATIONAL ISO
STANDARD 24603
First edition
2022-08
Biotechnology — Biobanking —
Requirements for human and mouse
pluripotent stem cells
Biotechnologie — Biobanking — Exigences relatives aux cellules
souches pluripotentes humaines et murines
Reference number
© ISO 2022
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ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 5
5 General requirements . 6
5.1 General . 6
5.2 Legal and ethical requirements . 6
5.3 Personnel, facilities and equipment . 6
5.4 Reagents, consumables and other supplies . 7
5.5 Management of information and data . 7
6 Collection of biological source materials and associated data. 8
6.1 Information about the human donor and requirements for the biological material . 8
6.2 Information about the mouse donor and requirements for the biological material . 8
6.3 Collection procedure . 9
7 Transport of the biological source material or PSCs and associated data to the
biobank . 9
8 Reception and traceability of the biological source material or PSCs and associated
data .10
9 Establishment of cell lines .10
9.1 Processes . 10
9.2 Unique identification . 10
9.3 Testing for infectious agents . 10
10 Characterization .11
10.1 General . 11
10.2 Population doubling time and subculture/passage.12
10.2.1 PDT . 12
10.2.2 Subculture/passage .13
10.3 Stability of the culture .13
10.4 Functionality . 14
10.4.1 General . 14
10.4.2 In vitro differentiation . 14
10.5 Microbial contamination . 14
11 Quality control .14
12 Testing.15
13 Cell line management .15
14 Preservation of cell lines .15
15 Storage .16
16 Thawing .16
17 Disposal .17
18 Distribution .17
18.1 General requirements . 17
18.2 Information for users . 17
18.3 Transport . 18
Annex A (informative) Potency comparison .21
iii
Annex B (informative) Examples for methods for the establishment and culture of PSCs .22
Annex C (informative) Quality control procedure for biobanking of human and mouse PSCs .26
Bibliography .27
iv
Foreword
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v
Introduction
Pluripotent stem cells (PSCs), including embryonic stem cells (ESCs) and induced pluripotent stem cells
(iPSCs), have been extensively studied in scientific research in order to improve the understanding
of developmental biology and diseases, to create organoids for drug screening, and to be applied in
cell-based therapies. In just a few years, thousands of PSC lines have been established in laboratories
around the world. PSC lines hold unique characteristics and behaviour due to their capability for both
self-renewal and differentiation into multiple cell types. However, the stem cell phenotype can be
changed by suboptimal cell culture technique, prolonged passage or changing the culture conditions.
Clearly the consequences of using adversely affected cells would be wasted time and resources but,
even more seriously, the generation of erroneous data in the literature which could both confuse
and delay scientific progress in this area. Accordingly, mouse PSCs have been used to establish our
fundamental understanding of PSC biology and these discoveries have been translated into human PSC
research to drive the development of new human-cell-based in vitro assays and potential regenerative
medicines. Mouse PSCs and human PSCs have become the most widely studied species in this field and
many significant scientific advances have been made by using PSCs from these two species. Of course,
PSC lines have been established from other species such as rat, porcine, canine, bovine, primate, etc.
and those from primates in particular have provided understanding of the biology of these cells which
can be more relevant to human stem cell biology than data from mouse PSCs. However, PSCs from
these species are much less used in research laboratories than mouse and human and are therefore not
described specifically in this document although much of this document will be relevant to them.
Human PSCs developed in research environments will give the clues to the development of cell
...