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  • BSI
    PAS 93:2011 Characterization of human cells for clinical applications. Guide
    Edition: 2011
    $151.82
    / user per year

Description of PAS 93:2011 2011

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.



Standard NumberPAS 93:2011
TitleCharacterization of human cells for clinical applications. Guide
StatusWithdrawn
Publication Date2011-08-31
Withdrawn Date2022-04-19
DescriptorsImpurities, Identification methods, Clinical medicine, Diagnosis (medical), Human body, Cytology, Purity, Cells (biology), Biological analysis and testing, Human biology, Standardization, Medical sciences, Regulations
ICS11.100.01 Laboratory medicine in general
CommitteeZZ/1
ISBN978 0 580 69850 7
PublisherBSI
Pages36

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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