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

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




DOWNLOAD your PDF copy of PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide for FREE
 

What is this PAS about?

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

Who is this PAS for? 

  • Product developers at all stages but crucially at the early stages of development
  • Organizations and individuals with an interest in the development of cell-based medicinal products

Why should you use this PAS? 

It offers recommendations and guidelines covering biological materials to be used in the production of cell-based medicinal products. This include gene therapies where the cells form part of the final drug product, such as ex-vivo transduced cells, but does 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.


You might also be interested in: 





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
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
DescriptorsBiology, Biological analysis and testing, Cytology
ICS11.020.20
CommitteeZZ/4
ISBN978 0 580 89867 9
PublisherBSI
FormatA4
DeliveryNo
Pages32
File Size291 KB
NotesAvailable as free of charge download from http://shop.bsigroup.com/ProductDetail/?pid=0000000000 30321643
Price£58.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Collaborate, Innovate, Accelerate.


Worldwide Standards
We can source any standard from anywhere in the world