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BSI - BS PAS 157

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

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Organization: BSI
Publication Date: 30 April 2015
Status: active
Page Count: 32
ICS Code (Medical science): 11.020.20

Document History

BS PAS 157
April 30, 2015
Evaluation of materials of biological origin used in the production of cell-based medicinal products – Guide
A description is not available for this item.

References

This document is referenced by:
ISO TS 20399-2 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 2: Best practice guidance for ancillary material suppliers
Published by ISO on November 1, 2018
This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well...
This document is referenced by:
BS PD ISO/TS 20399-2 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 2: Best practice guidance for ancillary material suppliers
Published by BSI on December 31, 2018
A description is not available for this item.
This document is referenced by:
TS 23565 - Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
Published by ISO on October 1, 2021
This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This...
This document is referenced by:
PD ISO/TS 23565 - Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
Published by BSI on December 31, 2021
A description is not available for this item.
This document is referenced by:
BS ISO 20399 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products
Published by BSI on January 31, 2023
A description is not available for this item.
This document is referenced by:
20399 - Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
Published by ISO on December 1, 2022
This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical...
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