ISO 21973:2020

INTERNATIONAL ISO
STANDARD 21973
First edition
2020-06
Biotechnology — General
requirements for transportation of
cells for therapeutic use
Reference number
©
ISO 2020
© ISO 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 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General concepts . 4
5 Cell transportation specification . 5
5.1 General . 5
5.2 Items specified in the cell transportation specification . 5
5.2.1 General. 5
5.2.2 Information reflected in the cell transportation specification . 5
5.2.3 Capability of the cell transportation service provider and its external
service provider(s). 6
5.3 Risk management, verification and validation . 9
5.3.1 Risk management . 9
5.3.2 Verification and validation .10
6 Best practices for shipping container and labelling .10
6.1 General .10
6.2 Shipping container.11
6.2.1 Shipping container systems .11
6.2.2 Shipping container requirements .11
6.3 Labelling of the shipping container .12
6.3.1 Information to be labelled .12
6.3.2 Physical requirements for the label .13
6.3.3 Handling of labels.13
7 Operation .13
7.1 General operation .13
7.1.1 General.13
7.1.2 Preparation of shipment .13
7.1.3 Transportation .13
7.1.4 Inspection at the time of delivery.14
7.2 Traceability .14
7.3 System to handle exceptional operations .15
7.3.1 Emergency handling .15
7.3.2 Management in case of an incident.15
8 Organization .16
8.1 General .16
8.2 Personnel training .16
8.2.1 General.16
8.2.2 Training plans .16
8.2.3 Training records .17
8.3 Quality management system (QMS) considerations .17
9 Storage facility .18
9.1 General .18
9.2 Storage facility considerations .18
10 Documented information .18
Bibliography .19
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
through ISO technical committees. Each member body interested in a subject for which a technical
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 of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

Introduction
Cells for therapeutic use provide potential cures for the most challenging disease conditions. However,
in contrast to the unprecedented clinical benefits, managing the production and logistics of cells for
therapeutic use proves to be challenging. Not only the cost is exceedingly high to produce and transport
these products, the concerns over product safety and efficacy due to potential manufacturing or
transportation deficiencies have started mounting as more products are being developed and tested.
The cell therapy workflow begins with collection of cells (including tissues). With autologous cells for
therapeutic use, cells are collected from patients in the clinical setting before shipping to manufacturing
sites for processing and production. After manufacturing and testing for release, cells for therapeutic
use are transported to clinical sites for administration into patients.
Issues related to cell transportation have been identified in the product workflow. Some of these issues
include monitoring and controlling transportation conditions, managing traceability and maintaining
chain of custody, and establishing clear expectations and communications between cell product
manufacturer and transportation service provider. These issues all have significant impact on cells for
therapeutic use quality that can ultimately affect product safety and effectiveness. Therefore, there is
a need for standards to ensure cell transportation is appropriately and adequately planned, executed,
traced and documented.
This document intends to provide general requirements and points to consider for transportation
service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation
process.
Application of this document presupposes awareness of applicable legal requirements.
ISO 13022:2012, Annex G contains guidance for transport of human cells.
INTERNATIONAL STANDARD ISO 21973:2020(E)
Biotechnology — General requirements for transportation
of cells for therapeutic use
1 Scope
This document specifies general requirements and reviews the points to consider for the transportation
of cells for therapeutic use, including storage during transportation.
Transportation starts from the transfer of the packaged cells by the sender to the transportation
service provider and ends when the package is delivered to the receiver at its destination.
This document does not apply to transportation of cells within one facility.
This document includes the development of a transportation plan including verification and
validation, communication between the client and the transportation service provider, and associated
doc
...

INTERNATIONAL ISO
STANDARD 21973
First edition
2020-06
Biotechnology — General
requirements for transportation of
cells for therapeutic use
Reference number
©
ISO 2020
© ISO 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 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General concepts . 4
5 Cell transportation specification . 5
5.1 General . 5
5.2 Items specified in the cell transportation specification . 5
5.2.1 General. 5
5.2.2 Information reflected in the cell transportation specification . 5
5.2.3 Capability of the cell transportation service provider and its external
service provider(s). 6
5.3 Risk management, verification and validation . 9
5.3.1 Risk management . 9
5.3.2 Verification and validation .10
6 Best practices for shipping container and labelling .10
6.1 General .10
6.2 Shipping container.11
6.2.1 Shipping container systems .11
6.2.2 Shipping container requirements .11
6.3 Labelling of the shipping container .12
6.3.1 Information to be labelled .12
6.3.2 Physical requirements for the label .13
6.3.3 Handling of labels.13
7 Operation .13
7.1 General operation .13
7.1.1 General.13
7.1.2 Preparation of shipment .13
7.1.3 Transportation .13
7.1.4 Inspection at the time of delivery.14
7.2 Traceability .14
7.3 System to handle exceptional operations .15
7.3.1 Emergency handling .15
7.3.2 Management in case of an incident.15
8 Organization .16
8.1 General .16
8.2 Personnel training .16
8.2.1 General.16
8.2.2 Training plans .16
8.2.3 Training records .17
8.3 Quality management system (QMS) considerations .17
9 Storage facility .18
9.1 General .18
9.2 Storage facility considerations .18
10 Documented information .18
Bibliography .19
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
through ISO technical committees. Each member body interested in a subject for which a technical
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 of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

Introduction
Cells for therapeutic use provide potential cures for the most challenging disease conditions. However,
in contrast to the unprecedented clinical benefits, managing the production and logistics of cells for
therapeutic use proves to be challenging. Not only the cost is exceedingly high to produce and transport
these products, the concerns over product safety and efficacy due to potential manufacturing or
transportation deficiencies have started mounting as more products are being developed and tested.
The cell therapy workflow begins with collection of cells (including tissues). With autologous cells for
therapeutic use, cells are collected from patients in the clinical setting before shipping to manufacturing
sites for processing and production. After manufacturing and testing for release, cells for therapeutic
use are transported to clinical sites for administration into patients.
Issues related to cell transportation have been identified in the product workflow. Some of these issues
include monitoring and controlling transportation conditions, managing traceability and maintaining
chain of custody, and establishing clear expectations and communications between cell product
manufacturer and transportation service provider. These issues all have significant impact on cells for
therapeutic use quality that can ultimately affect product safety and effectiveness. Therefore, there is
a need for standards to ensure cell transportation is appropriately and adequately planned, executed,
traced and documented.
This document intends to provide general requirements and points to consider for transportation
service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation
process.
Application of this document presupposes awareness of applicable legal requirements.
ISO 13022:2012, Annex G contains guidance for transport of human cells.
INTERNATIONAL STANDARD ISO 21973:2020(E)
Biotechnology — General requirements for transportation
of cells for therapeutic use
1 Scope
This document specifies general requirements and reviews the points to consider for the transportation
of cells for therapeutic use, including storage during transportation.
Transportation starts from the transfer of the packaged cells by the sender to the transportation
service provider and ends when the package is delivered to the receiver at its destination.
This document does not apply to transportation of cells within one facility.
This document includes the development of a transportation plan including verification and
validation, communication between the client and the transportation service provider, and associated
doc
...