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BSI PAS 157:2015

BSI PAS 157:2015

$46.58

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

Published By Publication Date Number of Pages
BSI 2015 32
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This PAS gives guidance on the evaluation of materials of biological origin used in the production of cell-based medicinal products for human use; including those gene therapy products whereby the cells form part of the final drug product.

This PAS also includes guidance on identifying, assessing and controlling risks to patients associated with materials of biological origin.

This PAS covers the evaluation of all materials of biological origin that come into contact with the cellular active substance.

This PAS focuses primarily on materials of human and animal origin and their potential impurities and contaminants. However, reagents derived from diverse biological sources including plants, insects and marine organisms are also used in the development of cell-based medicinal products. Therefore the fundamental principles of risk management also apply for these materials.

This PAS also covers legislation for cell-based medicinal products and is intended for developers who wish to undertake clinical trials and/or license products in both the EU and the US.

This PAS does not cover the selection, assessment or control of cellular active substances, nor the starting materials as defined in Directive 2001/83/EC [1] and excipients. However, it is anticipated that these are still covered by general risk management procedures.

This PAS does not cover biological materials that are used in the development of any other biological medicinal product.

This PAS is applicable for product developers at all stages of development; however maximum benefits can be gained by the implementation of recommendations in this PAS in the early stages of development.

This PAS is intended for use by organizations and individuals with an interest in the development of cell-based medicinal products for clinical applications.

PDF Catalog

PDF Pages PDF Title
3 Contents
5 Foreword
6 Innovate UK statement
7 Introduction
9 1 Scope
2 Terms, definitions and abbreviations
11 3 Regulatory requirements and guidance applicable to biological materials used in the production of cell-based medicinal products (EU and US)
17 4 Evaluation criteria and mitigation of risk
22 5 Characterization of biological materials
23 6 Managing changes to materials
24 Annex A (informative) Excerpts of EC legislation that refer to raw materials
28 Annex B (informative) Regulatory documents and guidance referenced in this guide
29 Bibliography

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BSI PAS 157:2015
$46.58