Biotechnology -- Ancillary materials present during the production of cellular therapeutic products

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Biotechnologie -- Matériaux auxiliaires présents lors de la production de produits thérapeutiques cellulaires

General Information

Status
Published
Publication Date
03-Dec-2018
Technical Committee
Current Stage
6060 - International Standard published
Start Date
15-Nov-2018
Completion Date
04-Dec-2018
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ISO/TS 20399-1:2018 - Biotechnology -- Ancillary materials present during the production of cellular therapeutic products
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TECHNICAL ISO/TS
SPECIFICATION 20399-1
First edition
2018-11
Biotechnology — Ancillary materials
present during the production of
cellular therapeutic products —
Part 1:
General requirements
Biotechnologie — Matériaux auxiliaires présents lors de la production
de produits thérapeutiques cellulaires —
Partie 1: Exigences générales
Reference number
ISO/TS 20399-1:2018(E)
ISO 2018
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ISO/TS 20399-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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.
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved
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ISO/TS 20399-1:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviated terms .............................................................................................................................................................................................. 3

5 Considerations ........................................................................................................................................................................................................ 3

5.1 General considerations .................................................................................................................................................................... 3

5.2 Animal-derived components of AM ...................................................................................................................................... 3

5.2.1 General...................................................................................................................................................................................... 3

5.2.2 Levels of ADCF ................................................................................................................................................................... 3

5.2.3 Key considerations in the use of animal-derived components ................................................ 4

5.2.4 Viral inactivation .............................................................................................................................................................. 4

5.3 Mutual responsibilities for AMs ............................................................................................................................................... 4

5.4 Example workflow ............................................................................................................................................................................... 5

6 Ancillary material requirements ......................................................................................................................................................... 6

6.1 Quality management system ....................................................................................................................................................... 6

6.2 Information on ancillary material products and materials used to produce

ancillary materials ............................................................................................................................................................................... 6

Annex A (informative) Example of workflow from AM supplier to AM user ...............................................................7

Annex B (informative) Information on AM products and materials used to produce AM ............................8

Bibliography .............................................................................................................................................................................................................................10

© ISO 2018 – All rights reserved iii
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ISO/TS 20399-1:2018(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

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.
A list of all parts in the ISO/TS 20399 series can be found on the ISO website.

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 2018 – All rights reserved
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ISO/TS 20399-1:2018(E)
Introduction

Ancillary materials (AMs) are materials that come into contact with the cellular therapeutic product

during the manufacturing process, but are not intended to be in the final product.

AMs include culture media and growth factors, among other biological and non-biological components.

They can be a complex mixture of many components, and a variation in their lot-to-lot composition can

hamper the ability to produce consistent cellular therapeutic products with specified quality attributes.

As such, AMs can have implications with regard to the safety and effectiveness of a cellular therapeutic

product. Appropriate control of ancillary materials is determined by a risk-based approach.

This document specifies definitions and general requirements for AMs and contributes to their control

by suppliers and users of such materials.

The ISO/TS 20399 series provides general requirements and guidance regarding ancillary materials

to maintain a high level of lot-to-lot consistency, as well as the accompanying documentation, so that

consistent ancillary materials products and documentation provided by the suppliers can help AM users.

It is intended to ensure the quality and consistency of AMs used in the manufacturing of cellular

therapeutic products. Good manufacturing practice (GMP) is taken into account, when necessary.

© ISO 2018 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 20399-1:2018(E)
Biotechnology — Ancillary materials present during the
production of cellular therapeutic products —
Part 1:
General requirements
1 Scope

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell

processing of cellular therapeutic products.

This document is applicable to cellular therapeutic products, including those gene therapy products

whereby cells form part of the final product. It does not apply to products without cells.

This document does not cover the selection, assessment or control of starting materials and excipients.

NOTE International, regional or national regulations or requirements can also apply to specific topics

covered in this document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
ancillary material

material that comes into contact with the cell or tissue product during cell-processing, but is not

intended to be part of the final product formulation

Note 1 to entry: AMs exclude non-biological consumables (e.g. tissue culture flasks, bags, tubing, pipettes,

needles) and other plastic ware that comes into contact with the cell or tissue, but include consumables which

can have a biological component (e.g. coated dishes or beads).
Note 2 to entry: AMs exclude cells (e.g. feeder cells).
Note 3 to entry: In some cases AM is described as raw material.
3.2
AM user

entity who makes use of AM (3.1) and conducts cell-processing for cellular therapeutic product

3.3
AM supplier
entity who manufactures and/or supplies the AM (3.1) for AM user (3.2)
© ISO 2018 – All rights reserved 1
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ISO/TS 20399-1:2018(E)
3.4
animal-derived component free
ADCF
absence of animal or human origin material(s)

Note 1 to entry: The main purpose of defining ADCF is to provide necessary information for a user's risk

assessment of ancillary material.
Note 2 to entry: There are levels of ADCF, which are listed in 5.2.2.

Note 3 to entry: In some cases, animal-derived component free (ADCF) is described as animal origin free.

Note 4 to entry: In cases where there is absence of non-human animal components, the term xeno-free is

commonly used.
3.5
cellular therapeutic product
product containing cells as the active substance
EXAMPLE Cell therapy medicinal product, tissue engineered product.
3.6
chain of custody

responsibility for or control of materials as they move through each step of a process

Note 1 to entry: For the purpose of this document, “chain of custody” is the unbroken path of an AM product from

the production of AM to the end customer. It covers controls, distribution and logistics to the end-user.

3.7
excipient

material that is present in the cellular therapeutic product (3.5) administered to a patient(s), other than

the active substance(s)
EXAMPLE Cryopreservation components.

Note 1 to entry: For the purpose of this document, “active substance” corresponds to cellular therapeutic product.

3.8
maximum shelf life

period during which an AM (3.1) is expected to comply with the specifications, if stored under defined

conditions
3.9
specification

list of tests, references to analytical procedures, and appropriate acceptance criteria that would be

expected to be met to demonstrate suitability for its intended use definition
3.10
stability

characteristic of a material, when stored under specified conditions, to maintain a value(s) for stated

property(ies) within specified limits for a specified period of time

[SOURCE: ISO Guide 30:2015, 2.1.15, modified — “reference material” has been replaced by “material”,

“a specified property value” has been replaced by “a value(s) for stated property(ies)”, the Note 1 to

entry has been deleted.]
3.11
starting material

any substance of cellular origin that constitutes the cellular therapeutic product (3.5)

2 © ISO 2018 – All rights reserved
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ISO/TS 20399-1:2018(E)
4 Abbreviated terms
ADCF animal-derived component free
AM ancillary material
BSE bovine spongiform encephalopathy
CoA certificate of analysis
CoO
...

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