PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
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PAS 157:2015

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

Status : Current   Published : April 2015

Format
HARDCOPY



PAS 157: Evaluation of materials of biological origin in the production of cell-based medicinal products. Guide

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Download your copy of PAS 157:2015 for free.

PAS 157 aims to provide guidance to help developers improve the consistency and quality of the materials used in the production of cell-based medicinal products, with a view to eliminating/mitigating potential risks to product quality.

The recommendations cover biological materials that are used in the production of cell-based medicinal products and include gene therapies where the cells form part of the final drug product, such as ex-vivo transduced cells. They do not cover biological materials that are used in the development of any other medicinal product. 

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

It is applicable both in the European Union and the US.

PAS 157 is intended for product developers at all stages of development but maximum benefit can be gained if it is used during the early stages of development. 

It is also relevant to organizations and individuals with an interest in the development of cell-based medicinal products, even if they are not themselves developing these products.

Members of the steering group who worked on developing PAS 157 are as follows:

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

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Standard NumberPAS 157:2015
TitleEvaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
StatusCurrent
Publication Date30 April 2015
DescriptorsBiology, Biological analysis and testing, Cytology
ICS11.020.20
CommitteeZZ/4
ISBN978 0 580 89867 9
PublisherBSI
FormatA4
DeliveryNo
Pages32
File Size0 KB
NotesAvailable as free of charge download from http://shop.bsigroup.com/ProductDetail/?pid=0000000000 30321643
Price£50.00


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