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BSI PAS 93:2011

BSI PAS 93:2011

$46.58

Characterization of human cells for clinical applications. Guide

Published By Publication Date Number of Pages
BSI 2011 36
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This PAS gives guidance on the characterization of human cells being developed for clinical applications.

This PAS is not a regulatory guideline, but gives guidance on the need for characterization of cells and key current, available cell characterization techniques. The choice of characterization techniques needs to be made by the developer on a case-by-case basis depending on the intended use of the cells.

This PAS covers the need for the characterization of cellular starting materials and cellular active substances and the characterization parameters (including identity, purity, cellular impurities, biological activity and viability).

This PAS is intended for use by organizations and individuals with an interest in the development of human cells for clinical applications including academic groups, small and medium sized enterprises (SMEs) and larger industrial manufacturers and the general public.

The guidance in this PAS is applicable to the characterization of human cells in the context of EU and US regulation of cell therapy products, but it will be broadly relevant to all regions/markets that accept or refer to International Conference on Harmonisation (ICH) guidance in the regulation of biological medicinal products including cell therapy products.

This PAS is not a manual for developing a cell therapy product and does not cover:

  1. complete characterization programmes;

  2. characterization of the manufacturing process;

  3. quality systems used to retain a state of control when carrying out characterization;

  4. safety testing of cells and cell therapy products; and

    NOTE Requirements for safety testing of cells and cell therapy products are addressed in detail in relevant legislation and guidance documents.

  5. xenografts, xenogeneic feeder cells, whole organ or bone marrow transplants and blood transfusions.

PDF Catalog

PDF Pages PDF Title
5 Contents
7 Ministerial statement
8 Foreword
9 Introduction
11 1 Scope
2 Terms, definitions and abbreviated terms
2.1 Terms and definitions
2.2 Abbreviations
12 3 The need for characterization
3.1 Scientific need for characterization
13 3.2 Regulatory need for characterization
15 4 Provenance of the cells
5 Characterization of cells
5.1 Identity
16 5.2 Purity
17 5.3 Biological activity
5.4 Viability
5.5 Specification
19 Annex A (informative) Cell characterization techniques
32 Bibliography
34 British Standards Institution (BSI)

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BSI PAS 93:2011
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