BS ISO 21709:2020+A1:2021

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Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

Published By	Publication Date	Number of Pages
BSI	2021	26

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This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines.

This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies.

This document does not apply to biological material intended for therapeutic use.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages	PDF Title
2	National foreword
7	Foreword
8	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
11	4 Requirements 4.1 General 4.2 Legal and ethical requirements 4.3 Facilities 4.3.1 General
12	4.3.2 Cell culture facility 4.4 Equipment 4.4.1 General
13	4.4.2 Equipment inspection 4.5 Reagents
14	4.6 Personnel 4.6.1 General 4.6.2 Personnel competence 4.6.3 Personnel training 4.6.4 Biorisk and biosafety of personnel
15	5 Process requirements 5.1 Establishment of cell lines within the biobank 5.1.1 General 5.1.2 Isolation and purification of primary cells 5.1.3 Primary cultures
16	5.1.4 Cell lines 5.2 Reception of established cell lines 5.2.1 General 5.2.2 Review of the deposit request
17	5.2.3 Decision on the deposit request 5.2.4 Transfer of material and associated data
18	5.2.5 Characterization and authentication of the cell line
19	5.2.6 Assignment of accession number 5.3 Cell line management 5.3.1 Planning for cell banking 5.3.2 Accession 5.3.3 Propagation of cell lines
20	5.3.4 Preservation and storage 5.3.5 Inventory management
21	5.3.6 Disposal management 5.4 Distribution 5.4.1 General 5.4.2 Acceptance of order request 5.4.3 Distribution review 5.4.4 Transport
22	5.5 Quality control, validation and verification 5.5.1 Quality control
23	5.5.2 Validation and verification 6 Performance evaluation and improvement
24	Annex A (informative) Recommended units for biobanking of cell lines
25	Bibliography