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BS ISO 24651:2022

BS ISO 24651:2022

$167.15

Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from bone marrow

Published By Publication Date Number of Pages
BSI 2022 36
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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
15 5 General requirements
5.1 General
5.2 Personnel, facilities and equipment
16 5.3 Reagents, consumables and other supplies
5.4 Management of information and data
6 Collection of bone marrow samples and associated data
6.1 Information about the bone marrow donor
17 6.2 Anatomical collection site
6.3 Collection volume
6.4 Collection procedure
6.4.1 General
18 6.4.2 Obtaining bone marrow by puncturing into the intramedullary canal
6.4.3 Obtaining bone marrow by aspirate
7 Transport of bone marrow samples or hBM-MSCs and associated data to the biobank
8 Reception and traceability of bone marrow or hBM-MSCs and associated data
19 9 Isolation and expansion of hBM-MSCs
9.1 Processes
9.2 Unique identification
9.3 Testing for infectious agents
9.4 Isolation of hBM-MSCs from bone marrow samples obtained by puncturing into the intramedullary canal and primary culture
20 9.5 Isolation of hBM-MSCs from bone marrow samples obtained by aspirate and primary culture
9.6 Subculture and limited expansion
10 Characterization of hBM-MSCs
10.1 General
21 10.2 Viability
10.3 Morphology
10.4 Population doubling time and subculture/passage
10.4.1 PDT
22 10.4.2 Subculture/passage
10.5 Cell population purity
10.6 In vitro self-renewal assessment
10.7 Proliferation
23 10.8 Differentiation capability — In vitro multilineage differentiation
10.8.1 General
10.8.2 In vitro adipogenic differentiation
10.8.3 In vitro chondrogeneic differentiation
24 10.8.4 In vitro osteogenic differentiation
10.9 Immunophenotyping by flow cytometry
25 10.10 Paracrine secretion/expression (protein-based assay of secretome)
10.11 Immunoregulation (modulation of immune cells)
26 10.12 Microbial contamination
11 Quality control
27 12 Storage
28 13 Thawing
14 Disposal
15 Distribution of hBM-MSCs — Information for users
29 16 Transport of hBM-MSCs
16.1 General
30 16.2 hBM-MSCs frozen in ampoules or cryovials
16.3 Living hBM-MSC cultures
31 Annex A (informative) Preparation of human bone marrow mononuclear cells (hBM-MNCs)
32 Bibliography

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BS ISO 24651:2022
$167.15