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BSI PD ISO/TS 22859-1:2022

BSI PD ISO/TS 22859-1:2022

$167.15

Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Published By Publication Date Number of Pages
BSI 2022 44
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PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 Abbreviated terms and symbols
18 5 General requirements
5.1 General
5.2 Personnel, facilities and equipment
19 5.3 Reagents, consumables and other supplies
5.4 Management of information and data
6 Collection of umbilical cord and associated data
6.1 Information about the umbilical cord donor
20 6.2 Collection procedure
21 7 Transport of umbilical cord or hUC-MSCs and associated data to the biobank
8 Reception and traceability of umbilical cord tissue or hUC-MSCs and associated data
9 Isolation and expansion of hUC-MSCs
9.1 Processes
22 9.2 Unique identification
9.3 Testing for infectious agents
9.4 Isolation of hUC-MSCs and primary culture
9.5 Subculture and limited expansion
10 Characterization of hUC-MSCs
10.1 General
23 10.2 Viability
10.3 Morphology
24 10.4 Population doubling time and subculture/passage
10.4.1 PDT
10.4.2 Subculture/passage
25 10.5 Cell population purity
10.6 In vitro self-renewal assessment
10.7 Proliferation
10.8 Differentiation capability — In vitro multilineage differentiation
10.8.1 General
10.8.2 In vitro adipogenic differentiation
26 10.8.3 In vitro chondrogenic differentiation
10.8.4 In vitro osteogenic differentiation
27 10.9 Immunophenotyping by flow cytometry
28 10.10 Paracrine secretion/expression (protein-based assay of secretome)
10.11 Immunoregulation (modulation of immune cells)
29 10.12 Microbial contamination
11 Quality control
30 12 Storage
31 13 Thawing
32 14 Disposal
15 Distribution of hUC-MSCs — Information for users
33 16 Transport of hUC-MSCs
16.1 General
16.2 hUC-MSCs frozen in ampoules or cryovials
34 16.3 Living hUC-MSC cultures
35 Annex A (informative) Exemplary quality control test procedure for biobanking of hUC-MSCs
36 Annex B (informative) Examples for suitable methods for the isolation and primary culture of hUC-MSCs
38 Annex C (informative) Exemplary methods for characterization of hUC-MSCs
40 Bibliography

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BSI PD ISO/TS 22859-1:2022
$167.15