ISO/TS 22859:2022
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport.
This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development.
This document does not apply to hUC-MSCs 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms and symbols
5 General requirements
5.1 General
5.2 Personnel, facilities and equipment
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
6.2 Collection procedure
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
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
10.2 Viability
10.3 Morphology
10.4 Population doubling time and subculture/passage
10.4.1 PDT
10.4.2 Subculture/passage
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
10.8.3 In vitro chondrogenic differentiation
10.8.4 In vitro osteogenic differentiation
10.9 Immunophenotyping by flow cytometry
10.10 Paracrine secretion/expression (protein-based assay of secretome)
10.11 Immunoregulation (modulation of immune cells)
10.12 Microbial contamination
11 Quality control
12 Storage
13 Thawing
14 Disposal
15 Distribution of hUC-MSCs — Information for users
16 Transport of hUC-MSCs
16.1 General
16.2 hUC-MSCs frozen in ampoules or cryovials
16.3 Living hUC-MSC cultures
Annex A (informative) Exemplary quality control test procedure for biobanking of hUC-MSCs
Annex B (informative) Examples for suitable methods for the isolation and primary culture of hUC-MSCs
Annex C (informative) Exemplary methods for characterization of hUC-MSCs
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms and symbols
5 General requirements
5.1 General
5.2 Personnel, facilities and equipment
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
6.2 Collection procedure
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
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
10.2 Viability
10.3 Morphology
10.4 Population doubling time and subculture/passage
10.4.1 PDT
10.4.2 Subculture/passage
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
10.8.3 In vitro chondrogenic differentiation
10.8.4 In vitro osteogenic differentiation
10.9 Immunophenotyping by flow cytometry
10.10 Paracrine secretion/expression (protein-based assay of secretome)
10.11 Immunoregulation (modulation of immune cells)
10.12 Microbial contamination
11 Quality control
12 Storage
13 Thawing
14 Disposal
15 Distribution of hUC-MSCs — Information for users
16 Transport of hUC-MSCs
16.1 General
16.2 hUC-MSCs frozen in ampoules or cryovials
16.3 Living hUC-MSC cultures
Annex A (informative) Exemplary quality control test procedure for biobanking of hUC-MSCs
Annex B (informative) Examples for suitable methods for the isolation and primary culture of hUC-MSCs
Annex C (informative) Exemplary methods for characterization of hUC-MSCs
Bibliography