ISO 18162:2024
(Main)Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells
Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells
This document specifies requirements for the biobanking of human neural stem cells (hPSC-NSCs) derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control (QC), storage, thawing and transport of hPSC-NSCs. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of hPSC-NSCs used for research and development in the life sciences. This document does not apply to hPSC-NSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements or multiple of them can also apply to specific topics covered in this document.
Biotechnologie — Biobanque — Exigences relatives aux cellules souches neuronales humaines dérivées de cellules souches pluripotentes
General Information
Standards Content (Sample)
International
Standard
ISO 18162
First edition
Biotechnology — Biobanking —
2024-12
Requirements for human neural
stem cells derived from pluripotent
stem cells
Biotechnologie — Biobanque — Exigences relatives aux cellules
souches neuronales humaines dérivées de cellules souches
pluripotentes
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 5
5 General requirements . 6
5.1 General .6
5.2 Legal and ethical requirements .7
5.3 Personnel, facilities and equipment .7
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 to the establishment,
characterization and QC of hPSCs . 8
7 Generation of hPSC-NSCs from hPSCs . 8
7.1 Processes .8
7.2 Unique identification .8
7.3 Testing for infectious agents .8
7.4 Generation of hNSCs and culture .8
7.5 Subculture and limited expansion .9
8 Characterization of hPSC-NSCs . 9
8.1 General .9
8.2 Viability .10
8.3 Morphology . .10
8.4 Population doubling time and subculture/passage.11
8.4.1 PDT .11
8.4.2 Subculture/passage .11
8.5 Cell population purity .11
8.6 Proliferation .11
8.7 Differentiation capability — in vitro multi-cell type differentiation . 12
8.7.1 General . 12
8.7.2 In vitro neuronal and glial differentiation . 12
8.8 Immunophenotyping by flow cytometry . 12
8.9 Microbial contamination . 13
8.10 Neural replacement and functional recovery . 13
9 Quality control . 14
10 Storage . 14
11 Thawing .15
12 Disposal . 16
13 Distribution of hPSC-NSCs — Information for users .16
14 Transport of hPSC-NSCs . 17
14.1 General .17
14.2 hPSC-NSCs frozen in ampoules or cryovials .17
14.3 Living hNSC cultures .17
Annex A (informative) Exemplary quality control test procedure for biobanking of hPSC-NSCs . 19
Annex B (informative) Examplary methods for the generation of hNSC from hPSCs .20
Bibliography .24
iii
Foreword
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iv
Introduction
Neural stem cells (NSCs) are the adult stem cells in the central nervous system (CNS). NSCs have self-
renewal ability and multipotency. NSCs can differentiate into various neurons and glial cells including
astrocytes and oligodendrocytes. NSCs play a major role in embryonic development and adult neurogenesis.
According to the hypothesis by Alvarez-Buylla, there are several types of cells can be called NSCs, including
[1]
neuroepithelium – epithelial cells of the ventricular zone (VZ) of the neural tube , radial glial cells (RGCs)
[2-4]
and basal (intermediate) progenitor cell (IPC) . In the adult, NSCs are restricted to specific brain regions,
such as the subventricular zone (SVZ) of the lateral ventricles and the subgranular zone (SGZ) of the dentate
[5]
gyrus (DG) of the hippocampus .
NOTE The term "neural" refers to any type of nerve cell, including a mixture of brain cells, whereas "neuronal" is
specifically related to neurons.
Despite these advances, substantial ambiguities persist regarding the nomenclature, nature, identity,
function, mode of isolation and experimental handling of these cells. NSCs are not fully defined by the initial
minimal criteria proposed out, and as such require careful characterization by a matrix of functional assays.
NSCs have been isolated from human fetal CNS (brain or spinal cord), cerebrospinal fluid, biopsy and autopsy
material, or differentiated from pluripotent stem cells (PSCs), which are widely used for animal and clinical
[6]
research . NSCs generated from different sources or differentiation protocols have different properties.
Different institutions use different practices for isolating, processing and biobanking these NSCs, making it
difficult to com
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