Foreword

This PAS was sponsored by Innovate UK. Its development was facilitated by BSI Standards Limited and it was published under licence from The British Standards Institution. It came into effect on 31 March 2015.

This PAS was sponsored by Innovate UK. Its development was facilitated by BSI Standards Limited and it was published under licence from The British Standards Institution. It came into effect on 31 March 2015.

Acknowledgement is given to Patrick Ginty of Cell Therapy Catapult, as the technical author, and the following organizations that were involved in the development of this PAS as members of the steering group:

• CellData Services
• Cell Medica
• Consulting on Advanced Biologicals Limited
• GlaxoSmithKline (GSK)
• National Institute for Biological Standards and Control (NIBSC)
• Roslin Cells
• University College London

Acknowledgement is also given to the members of a wider review panel who were consulted in the development of this PAS.

The British Standards Institution retains ownership and copyright of this PAS. BSI Standards Limited as the publisher of the PAS reserves the right to withdraw or amend this PAS on receipt of authoritative advice that it is appropriate to do so. This PAS will be reviewed at intervals not exceeding two years, and any amendments arising from the review will be published as an amended PAS and publicized in Update Standards.

This PAS is not to be regarded as a British Standard. It will be withdrawn upon publication of its content in, or as, a British Standard.

The PAS process enables a guide to be rapidly developed in order to fulfil an immediate need in industry. A PAS can be considered for further development as a British Standard, or constitute part of the UK input into the development of a European or International Standard.

Relationship with other publications

This PAS builds on the content of three previous related PAS documents:

PAS 83 , Developing human cells for clinical applications in the European Union and the United States of America – Guide,PAS 84, Cell therapy and regenerative medicine – Glossary and PAS 93, Characterization of human cells for clinical applications – Guide. PAS 83 provides a detailed description of the development pathway and accompanying regulatory framework applicable to cellular therapy products for clinical use whereas PAS 84 provides a glossary of terms for cell therapy and regenerative medicine. PAS 93 provides guidance on the characterization of human cells for clinical applications within a regulatory context.

Use of this document

As a guide, this PAS takes the form of guidance and recommendations. It should not be quoted as if it were a specification or a code of practice and claims of compliance cannot be made to it.

It has been assumed in the preparation of this PAS that the execution of its provisions will be entrusted to appropriately qualified and experienced people, for whose use it has been produced.

Presentational conventions

The guidance in this standard is presented in roman (i.e. upright) type. Any recommendations are expressed in sentences in which the principal auxiliary verb is “should”.

Commentary, explanation and general informative material is presented in smaller italic type, and does not constitute a normative element.

Contractual and legal considerations

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a PAS cannot confer immunity from legal obligations.

Amendments/corrigenda issued since publication

Date	Text affected

PAS 157:2015

Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide

Published:

30 Apr 2015

Withdrawn:

14 Feb 2024