ISO INTERNATIONAL STANDARD 21709 First edition 2020-11 Biotechnology Biobanking Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines Biotechnologie - Biobanking - Exigences de processus et de qualité pour la génération, le maintien et la caractérisation des lignées cellulaires de mammiferes Reference number ISO 21709:2020(E) ISO ISO2020 IS0 21709:2020(E) COPYRIGHT PROTECTED DOCUMENT @iS0 2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2020 - All rights reserved IS0 21709:2020(E) Contents Page Foreword .V Introduction. ..vi 1 Scope. .1 2 Normative references. ..1 3 Terms and definitions .1 4 Requirements .3 4.1 General. 3 4.2 Legal and ethical requirements 3 4.3 Facilities 4 4.3.1 General. 4 4.3.2 Cell culture facility 4 4.4 Equipment. .4 4.4.1 General. 4 4.4.2 Equipment inspection .5 4.5 Reagents 6 4.6 Informed consent. 6 4.6.1 General. .6 4.6.2 Procedure ofobtaining informed consent 6 4.6.3 Specialcircumstancesforinformedconsent 7 4.6.4 Information provided to the donor/patient or the donor's/patient's legally designated or nominated representative. 7 4.6.5 Informed consent signature. 8 4.7 Personnel 8 4.7.1 General. 8 4.7.2 Personnel competence. 9 4.7.3 Personnel training 9 4.7.4 Biorisk and biosafety of personnel 9 5 Process requirements 9 5.1 Establishment of cell lines within the biobank .9 5.1.1 General. 9 5.1.2 Isolation and purification of primary cells 10 5.1.3 Primary cultures 10 5.1.4 Cell lines 11 5.2 Reception of established cell lines 11 5.2.1 General. 11 5.2.2 Review of the deposit request. 11 5.2.3 Decision on the deposit request 12 5.2.4 Transfer of material and associated data 12 5.2.5 Characterization and authentication of the cell line 13 5.2.6 Assignment of accession number. 13 5.3 Cell line management. 14 5.3.1 Planning for cell banking .14 5.3.2 Accession 14 5.3.3 Propagation of cell lines 14 5.3.4 Preservation and storage. 15 5.3.5 Inventory management .15 5.3.6 Disposal management. 15 5.4 Distribution. 16 5.4.1 General. 16 5.4.2 Acceptance of order request. 16 5.4.3 Distribution review 5.4.4 Transport. 16 @ IS0 2020 - All rights reserved ii IS0 21709:2020(E) 5.5 Quality control, validation and verification ..17 5.5.1 Quality control. 5.5.2 Validation and verification ..17 Performance evaluation and improvement ..17 6 Annex A (informative) Recommended units for biobanking of cell lines ..19 Bibliography .20 iv @ IS0 2020 - All rights reserved IS0 21709:2020(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out throughIsotechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnica. committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with Iso, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of IsO documents should be noted. This document was drafted in accordance with the editorial rules